NCT01587703 · OUTCOME
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16
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 Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure What was measured Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Analysis population: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Groups in this outcome 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
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 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Reported measurements Glucose; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 Not reported Not reported Not reported Not reported
Glucose; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Glucose; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Albumin; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported
Albumin; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Albumin; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
ALP; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
ALP; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
ALP; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
ALT; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
ALT; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
ALT; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Amylase; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Amylase; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Amylase; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
AST; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
AST; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
AST; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Dir bil; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Dir bil; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Dir bil; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Bilirubin; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4 Not reported Not reported Not reported Not reported
Bilirubin; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported
Bilirubin; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
NT-BNP; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
NT-BNP; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
NT-BNP; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Calcium; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported
Calcium; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Calcium; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Cholesterol; Any grade increase; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Cholesterol; Increase to Grade 3; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Cholesterol; Increase to Grade 4; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CK; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CK; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CK; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Chloride; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Chloride; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Chloride; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CO2; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CO2; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
CO2; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Creatinine; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
Creatinine; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Creatinine; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
GGT; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
GGT; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
GGT; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
HDL; Any grade increase; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
HDL; Increase to Grade 3; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
HDL; Increase to Grade 4; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Insulin; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Insulin; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Insulin; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Potassium; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported
Potassium; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Potassium; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
LDL; Any grade increase; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
LDL; Increase to Grade 3; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
LDL; Increase to Grade 4; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Lipase; Any grade increase; n=5,4 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Lipase; Increase to Grade 3; n=5,4 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Lipase; Increase to Grade 4;n=5,4 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 4
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Magnesium; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
Magnesium; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
Magnesium; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Protein; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Protein; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Protein; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Sodium; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3 Not reported Not reported Not reported Not reported
Sodium; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported
Sodium; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Thyroxine; Any grade increase; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Thyroxine; Increase to Grade 3; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Thyroxine; Increase to Grade 4; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Testosterone; Any grade increase; n=2,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Testosterone; Increase to Grade 3; n=2,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Testosterone; Increase to Grade 4; n=2,1 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Triglycerides; Any grade increase; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 2 Not reported Not reported Not reported Not reported
Triglycerides; Increase to Grade 3; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Triglycerides; Increase to Grade 4; n=5,3 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 3
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin I; Any grade increase; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin I; Increase to Grade 3; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin I; Increase to Grade 4; n=1,0 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 1 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin T; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin T; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Troponin T; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urate; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urate; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urate; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urea; Any grade increase; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urea; Increase to Grade 3; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Urea; Increase to Grade 4; n=5,5 Analysis denominator · Participants
Group Source count 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 5
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 4
group Id OG001
value 5 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Glucose; Any grade increase; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Glucose; Increase to Grade 3; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Glucose; Increase to Grade 4; n=5,5 categories measurements
group Id OG000
value 3
group Id OG001
value 3 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Albumin; Any grade increase; n=5,5 categories measurements
group Id OG000
value 1
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Albumin; Increase to Grade 3; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title Albumin; Increase to Grade 4; n=5,5 categories measurements
group Id OG000
value 1
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALP; Any grade increase; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALP; Increase to Grade 3; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALP; Increase to Grade 4; n=5,5 categories measurements
group Id OG000
value 1
group Id OG001
value 1 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALT; Any grade increase; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALT; Increase to Grade 3; n=5,5 categories measurements
group Id OG000
value 0
group Id OG001
value 0 denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
title ALT; Increase to Grade 4; n=5,5 Show more (12 of 93) denoms counts
group Id OG000
value 5
group Id OG001
value 5
units Participants
description Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. groups
description Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
id OG000
title 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes
description Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
id OG001
title 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
param Type COUNT_OF_PARTICIPANTS
population Description All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
reporting Status POSTED
time Frame Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
title Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle