NCT02981368 · OUTCOME

Shift From Baseline in Selected Clinical Chemistry 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 clinical chemistry 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 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 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 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 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

Alkaline Phosphatase

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	8
Cohort B - Follow-up Value: Low	0
Cohort A - Follow-up Value: Normal	218
Cohort B - Follow-up Value: Normal	61
Cohort A - Follow-up Value: High	3
Cohort B - Follow-up Value: High	13
Cohort A - Follow-up Value: Missing	39
Cohort B - Follow-up Value: Missing	43

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	3	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	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: 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	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	4	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	5	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	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	38	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	61	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	4	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	35	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	3	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	9	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	4	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	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: Missing

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	0
Cohort B - Follow-up Value: Low	1
Cohort A - Follow-up Value: Normal	207
Cohort B - Follow-up Value: Normal	67
Cohort A - Follow-up Value: High	21
Cohort B - Follow-up Value: High	6
Cohort A - Follow-up Value: Missing	40
Cohort B - Follow-up Value: Missing	43

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Cohort B - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	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	197	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	7	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	35	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	67	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	42	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	9	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	14	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	4	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	4	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	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: Missing

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	12
Cohort B - Follow-up Value: Low	0
Cohort A - Follow-up Value: Normal	199
Cohort B - Follow-up Value: Normal	61
Cohort A - Follow-up Value: High	12
Cohort B - Follow-up Value: High	10
Cohort A - Follow-up Value: Missing	45
Cohort B - Follow-up Value: Missing	46

Cohort A - Baseline Value: Low

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	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 B - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	8	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	193	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	4	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	43	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	60	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	4	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	45	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	8	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	5	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	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: 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	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

Bilirubin

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	1
Cohort B - Follow-up Value: Low	0
Cohort A - Follow-up Value: Normal	200
Cohort B - Follow-up Value: Normal	70
Cohort A - Follow-up Value: High	28
Cohort B - Follow-up Value: High	4
Cohort A - Follow-up Value: Missing	39
Cohort B - Follow-up Value: Missing	43

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Cohort B - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	1	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	22	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	33	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	69	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	41	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	5	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	6	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	5	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	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	2	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	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: Missing

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Calcium

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	26
Cohort B - Follow-up Value: Low	1
Cohort A - Follow-up Value: Normal	223
Cohort B - Follow-up Value: Normal	83
Cohort A - Follow-up Value: High	1
Cohort B - Follow-up Value: High	0
Cohort A - Follow-up Value: Missing	18
Cohort B - Follow-up Value: Missing	33

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	1	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 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	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	0	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	25	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	219	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	18	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	81	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	32	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	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	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	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Creatinine

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	2
Cohort B - Follow-up Value: Low	5
Cohort A - Follow-up Value: Normal	231
Cohort B - Follow-up Value: Normal	71
Cohort A - Follow-up Value: High	19
Cohort B - Follow-up Value: High	8
Cohort A - Follow-up Value: Missing	16
Cohort B - Follow-up Value: Missing	33

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	1	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	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: 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	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	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	0	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	1	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	223	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	9	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	15	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	66	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	32	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	8	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	6	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	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	2	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: 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	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	0	Not reported	Not reported	Not reported	Not reported

Glucose

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	0
Cohort B - Follow-up Value: Low	2
Cohort A - Follow-up Value: Normal	178
Cohort B - Follow-up Value: Normal	39
Cohort A - Follow-up Value: High	73
Cohort B - Follow-up Value: High	43
Cohort A - Follow-up Value: Missing	17
Cohort B - Follow-up Value: Missing	33

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Cohort B - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	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	155	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	19	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	9	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	25	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	14	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	16	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	20	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	53	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	7	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	13	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	29	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	17	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	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: 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	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	0	Not reported	Not reported	Not reported	Not reported

Potassium

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	5
Cohort B - Follow-up Value: Low	2
Cohort A - Follow-up Value: Normal	237
Cohort B - Follow-up Value: Normal	78
Cohort A - Follow-up Value: High	7
Cohort B - Follow-up Value: High	1
Cohort A - Follow-up Value: Missing	19
Cohort B - Follow-up Value: Missing	36

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	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	0	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	5	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	226	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	7	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	18	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	75	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	35	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	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	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	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	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	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	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: 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	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	0	Not reported	Not reported	Not reported	Not reported

Urea Nitrogen

Analysis denominator · Participants

Group	Source count
Cohort A - Follow-up Value: Low	3
Cohort B - Follow-up Value: Low	0
Cohort A - Follow-up Value: Normal	235
Cohort B - Follow-up Value: Normal	58
Cohort A - Follow-up Value: High	15
Cohort B - Follow-up Value: High	24
Cohort A - Follow-up Value: Missing	15
Cohort B - Follow-up Value: Missing	35

Cohort A - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	2	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 B - Baseline Value: Low

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	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	1	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	222	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	8	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	54	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	8	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	25	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	11	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	7	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: 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	4	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	16	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: 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	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: Missing

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort A - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Low	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Normal	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: High	Not reported	Not reported	Not reported	Not reported
Cohort A - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported
Cohort B - Follow-up Value: Missing	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
3
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
0
group Id
OG007
value
0
title
Cohort A - Baseline Value: Low
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
4
title
Cohort B - Baseline Value: Low
measurements
group Id
OG000
value
5
group Id
OG001
value
0
group Id
OG002
value
210
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
38
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
61
group Id
OG004
value
0
group Id
OG005
value
4
group Id
OG006
value
0
group Id
OG007
value
35
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
3
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
9
group Id
OG006
value
0
group Id
OG007
value
4
title
Cohort B - Baseline Value: High
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: 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
8
group Id
OG001
value
0
group Id
OG002
value
218
group Id
OG003
value
61
group Id
OG004
value
3
group Id
OG005
value
13
group Id
OG006
value
39
group Id
OG007
value
43
units
Participants
title
Alkaline Phosphatase
categories
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 A - Baseline Value: Low
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: Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
197
group Id
OG003
value
0
group Id
OG004
value
7
group Id
OG005
value
0
group Id
OG006
value
35
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
67
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
42
title
Cohort B - Baseline Value: Normal
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
9
group Id
OG003
value
0
group Id
OG004
value
14
group Id
OG005
value
0
group Id
OG006
value
4
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
4
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
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: 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
0
group Id
OG001
value
1
group Id
OG002
value
207
group Id
OG003
value
67
group Id
OG004
value
21
group Id
OG005
value
6
group Id
OG006
value
40
group Id
OG007
value
43
units
Participants
title
Alanine Aminotransferase
categories
measurements
group Id
OG000
value
4
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 A - Baseline Value: Low
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: Low
measurements
group Id
OG000
value
8
group Id
OG001
value
0
group Id
OG002
value
193
group Id
OG003
value
0
group Id
OG004
value
4
group Id
OG005
value
0
group Id
OG006
value
43
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
60
group Id
OG004
value
0
group Id
OG005
value
4
group Id
OG006
value
0
group Id
OG007
value
45
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
8
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
5
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
1
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
1
group Id
OG006
value
0
group Id
OG007
value
0
title
Cohort B - Baseline Value: Missing
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
0
group Id
OG002
value
199
group Id
OG003
value
61
group Id
OG004
value
12
group Id
OG005
value
10
group Id
OG006
value
45
group Id
OG007
value
46
units
Participants
title
Aspartate Aminotransferase
categories
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 A - Baseline Value: Low
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: Low
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
194
group Id
OG003
value
0
group Id
OG004
value
22
group Id
OG005
value
0
group Id
OG006
value
33
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
69
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
41
title
Cohort B - Baseline Value: Normal
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
6
group Id
OG005
value
0
group Id
OG006
value
5
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
2
group Id
OG006
value
0
group Id
OG007
value
2
title
Cohort B - Baseline Value: High
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: 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
1
group Id
OG001
value
0
group Id
OG002
value
200
group Id
OG003
value
70
group Id
OG004
value
28
group Id
OG005
value
4
group Id
OG006
value
39
group Id
OG007
value
43
units
Participants
title
Bilirubin
categories
measurements
group Id
OG000
value
1
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 A - Baseline Value: Low
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
0
title
Cohort B - Baseline Value: Low
measurements
group Id
OG000
value
25
group Id
OG001
value
0
group Id
OG002
value
219
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
18
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
81
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
32
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
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
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
26
group Id
OG001
value
1
group Id
OG002
value
223
group Id
OG003
value
83
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
18
group Id
OG007
value
33
units
Participants
title
Calcium
categories
measurements
group Id
OG000
value
1
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
0
group Id
OG007
value
0
title
Cohort A - Baseline Value: Low
measurements
group Id
OG000
value
0
group Id
OG001
value
3
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
0
title
Cohort B - Baseline Value: Low
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
223
group Id
OG003
value
0
group Id
OG004
value
9
group Id
OG005
value
0
group Id
OG006
value
15
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
66
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
32
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
8
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
6
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
1
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
0
group Id
OG006
value
1
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
1
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
2
group Id
OG001
value
5
group Id
OG002
value
231
group Id
OG003
value
71
group Id
OG004
value
19
group Id
OG005
value
8
group Id
OG006
value
16
group Id
OG007
value
33
units
Participants
title
Creatinine
categories
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 A - Baseline Value: Low
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: Low
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
155
group Id
OG003
value
0
group Id
OG004
value
19
group Id
OG005
value
0
group Id
OG006
value
9
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
25
group Id
OG004
value
0
group Id
OG005
value
14
group Id
OG006
value
0
group Id
OG007
value
16
title
Cohort B - Baseline Value: Normal
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
20
group Id
OG003
value
0
group Id
OG004
value
53
group Id
OG005
value
0
group Id
OG006
value
7
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
13
group Id
OG004
value
0
group Id
OG005
value
29
group Id
OG006
value
0
group Id
OG007
value
17
title
Cohort B - Baseline Value: High
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: Missing
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
0
title
Cohort B - Baseline Value: Missing
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
178
group Id
OG003
value
39
group Id
OG004
value
73
group Id
OG005
value
43
group Id
OG006
value
17
group Id
OG007
value
33
units
Participants
title
Glucose
categories
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 A - Baseline Value: Low
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
0
title
Cohort B - Baseline Value: Low
measurements
group Id
OG000
value
5
group Id
OG001
value
0
group Id
OG002
value
226
group Id
OG003
value
0
group Id
OG004
value
7
group Id
OG005
value
0
group Id
OG006
value
18
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
75
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
35
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
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
1
group Id
OG004
value
0
group Id
OG005
value
1
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
4
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: Missing
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
0
title
Cohort B - Baseline Value: Missing
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
237
group Id
OG003
value
78
group Id
OG004
value
7
group Id
OG005
value
1
group Id
OG006
value
19
group Id
OG007
value
36
units
Participants
title
Potassium
categories
measurements
group Id
OG000
value
2
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 A - Baseline Value: Low
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: Low
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
222
group Id
OG003
value
0
group Id
OG004
value
8
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
54
group Id
OG004
value
0
group Id
OG005
value
8
group Id
OG006
value
0
group Id
OG007
value
25
title
Cohort B - Baseline Value: Normal
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
11
group Id
OG003
value
0
group Id
OG004
value
7
group Id
OG005
value
0
group Id
OG006
value
2
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
4
group Id
OG004
value
0
group Id
OG005
value
16
group Id
OG006
value
0
group Id
OG007
value
10
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
1
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
3
group Id
OG001
value
0
group Id
OG002
value
235
group Id
OG003
value
58
group Id
OG004
value
15
group Id
OG005
value
24
group Id
OG006
value
15
group Id
OG007
value
35
units
Participants
title
Urea Nitrogen

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

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 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 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 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 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 Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice