NCT01716806 · OUTCOME

Number of Participants With Laboratory Abnormalities

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-06-11

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: Up to 30 months

What was measured

Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.

Analysis population: All subjects who received at least one dose of study drug

Groups in this outcome

Part A

Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.

Part B

BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part C

BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.

Part D

BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part E

BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

Part F

BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

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
Part A	27
Part B	22
Part C	20
Part D	21
Part E	30
Part F	7

Reported measurements

Hemoglobin High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Hemoglobin High. Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Hemoglobin High. Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Hemoglobin High. Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Hemoglobin Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	10	Not reported	Not reported	Not reported	Not reported
Part B	6	Not reported	Not reported	Not reported	Not reported
Part C	10	Not reported	Not reported	Not reported	Not reported
Part D	9	Not reported	Not reported	Not reported	Not reported
Part E	13	Not reported	Not reported	Not reported	Not reported
Part F	4	Not reported	Not reported	Not reported	Not reported

Hemoglobin Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	5	Not reported	Not reported	Not reported	Not reported
Part B	6	Not reported	Not reported	Not reported	Not reported
Part C	6	Not reported	Not reported	Not reported	Not reported
Part D	5	Not reported	Not reported	Not reported	Not reported
Part E	6	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Hemoglobin Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Hemoglobin Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Leukocytes Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	3	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	5	Not reported	Not reported	Not reported	Not reported
Part F	4	Not reported	Not reported	Not reported	Not reported

Leukocytes Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	3	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Leukocytes Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Leukocytes Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Lymphocytes High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Lymphocytes High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Lymphocytes High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Lymphocytes Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	7	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Lymphocytes Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	4	Not reported	Not reported	Not reported	Not reported
Part B	7	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	6	Not reported	Not reported	Not reported	Not reported
Part E	7	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Lymphocytes Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	6	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	6	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Lymphocytes Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	9	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Neutrophils Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Neutrophils Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	4	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Neutrophils Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	3	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Neutrophils Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Platelets Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	4	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	8	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	5	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Platelets Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Platelets Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Platelets Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	8	Not reported	Not reported	Not reported	Not reported
Part B	9	Not reported	Not reported	Not reported	Not reported
Part C	6	Not reported	Not reported	Not reported	Not reported
Part D	16	Not reported	Not reported	Not reported	Not reported
Part E	7	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	4	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Albumin Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	8	Not reported	Not reported	Not reported	Not reported
Part B	6	Not reported	Not reported	Not reported	Not reported
Part C	9	Not reported	Not reported	Not reported	Not reported
Part D	9	Not reported	Not reported	Not reported	Not reported
Part E	6	Not reported	Not reported	Not reported	Not reported
Part F	3	Not reported	Not reported	Not reported	Not reported

Albumin Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	3	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	6	Not reported	Not reported	Not reported	Not reported
Part E	4	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Albumin Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Albumin Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	10	Not reported	Not reported	Not reported	Not reported
Part B	10	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	4	Not reported	Not reported	Not reported	Not reported
Part E	12	Not reported	Not reported	Not reported	Not reported
Part F	3	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	4	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Amylase High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	5	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Amylase High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Amylase High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Amylase High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	14	Not reported	Not reported	Not reported	Not reported
Part B	8	Not reported	Not reported	Not reported	Not reported
Part C	8	Not reported	Not reported	Not reported	Not reported
Part D	16	Not reported	Not reported	Not reported	Not reported
Part E	9	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	6	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Calcium Corrected for Albumin Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Creatinine High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	20	Not reported	Not reported	Not reported	Not reported
Part B	14	Not reported	Not reported	Not reported	Not reported
Part C	12	Not reported	Not reported	Not reported	Not reported
Part D	12	Not reported	Not reported	Not reported	Not reported
Part E	18	Not reported	Not reported	Not reported	Not reported
Part F	3	Not reported	Not reported	Not reported	Not reported

Creatinine High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Creatinine High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Creatinine High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glomerular Filtration Rate, Estimated Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Glomerular Filtration Rate, Estimated Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	11	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Glomerular Filtration Rate, Estimated Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glomerular Filtration Rate, Estimated Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glucose High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	15	Not reported	Not reported	Not reported	Not reported
Part B	13	Not reported	Not reported	Not reported	Not reported
Part C	12	Not reported	Not reported	Not reported	Not reported
Part D	12	Not reported	Not reported	Not reported	Not reported
Part E	11	Not reported	Not reported	Not reported	Not reported
Part F	3	Not reported	Not reported	Not reported	Not reported

Glucose High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	10	Not reported	Not reported	Not reported	Not reported
Part B	6	Not reported	Not reported	Not reported	Not reported
Part C	3	Not reported	Not reported	Not reported	Not reported
Part D	5	Not reported	Not reported	Not reported	Not reported
Part E	8	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Glucose High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	4	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Glucose High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glucose Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Glucose Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glucose Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Glucose Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Lipase High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Lipase High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Lipase High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Lipase High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Phosphate Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	9	Not reported	Not reported	Not reported	Not reported
Part B	8	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	7	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Phosphate Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	5	Not reported	Not reported	Not reported	Not reported
Part C	3	Not reported	Not reported	Not reported	Not reported
Part D	6	Not reported	Not reported	Not reported	Not reported
Part E	4	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Phosphate Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	4	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Phosphate Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Potassium High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Potassium High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Potassium High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Potassium High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Potassium Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	6	Not reported	Not reported	Not reported	Not reported
Part B	5	Not reported	Not reported	Not reported	Not reported
Part C	5	Not reported	Not reported	Not reported	Not reported
Part D	8	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	2	Not reported	Not reported	Not reported	Not reported

Potassium Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Potassium Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	2	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	3	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Potassium Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Sodium High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	2	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Sodium High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Sodium High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Sodium High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Sodium Low, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	11	Not reported	Not reported	Not reported	Not reported
Part B	7	Not reported	Not reported	Not reported	Not reported
Part C	4	Not reported	Not reported	Not reported	Not reported
Part D	9	Not reported	Not reported	Not reported	Not reported
Part E	7	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Sodium Low, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Sodium Low, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	1	Not reported	Not reported	Not reported	Not reported
Part B	1	Not reported	Not reported	Not reported	Not reported
Part C	3	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	1	Not reported	Not reported	Not reported	Not reported

Sodium Low, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	0	Not reported	Not reported	Not reported	Not reported
Part E	1	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	2	Not reported	Not reported	Not reported	Not reported
Part C	4	Not reported	Not reported	Not reported	Not reported
Part D	3	Not reported	Not reported	Not reported	Not reported
Part E	2	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	1	Not reported	Not reported	Not reported	Not reported
Part D	4	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	0	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	1	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Total Bilirubin High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Urate High, Grade 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Urate High, Grade 2

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part A	Not reported	Not reported	Not reported	Not reported
Part B	Not reported	Not reported	Not reported	Not reported
Part C	Not reported	Not reported	Not reported	Not reported
Part D	Not reported	Not reported	Not reported	Not reported
Part E	Not reported	Not reported	Not reported	Not reported
Part F	Not reported	Not reported	Not reported	Not reported

Urate High, Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	5	Not reported	Not reported	Not reported	Not reported
Part B	7	Not reported	Not reported	Not reported	Not reported
Part C	4	Not reported	Not reported	Not reported	Not reported
Part D	9	Not reported	Not reported	Not reported	Not reported
Part E	4	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Urate High, Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A	3	Not reported	Not reported	Not reported	Not reported
Part B	0	Not reported	Not reported	Not reported	Not reported
Part C	0	Not reported	Not reported	Not reported	Not reported
Part D	2	Not reported	Not reported	Not reported	Not reported
Part E	0	Not reported	Not reported	Not reported	Not reported
Part F	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
0
title
Hemoglobin High, Grade 1
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
title
Hemoglobin High. Grade 2
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
title
Hemoglobin High. Grade 3
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
title
Hemoglobin High. Grade 4
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
6
group Id
OG002
value
10
group Id
OG003
value
9
group Id
OG004
value
13
group Id
OG005
value
4
title
Hemoglobin Low, Grade 1
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
6
group Id
OG002
value
6
group Id
OG003
value
5
group Id
OG004
value
6
group Id
OG005
value
1
title
Hemoglobin Low, Grade 2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
title
Hemoglobin Low, Grade 3
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
title
Hemoglobin Low, Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
3
group Id
OG004
value
5
group Id
OG005
value
4
title
Leukocytes Low, Grade 1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
1
title
Leukocytes Low, Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
5
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
0
title
Leukocytes Low, Grade 3
categories
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
title
Leukocytes Low, Grade 4

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
22
group Id
OG002
value
20
group Id
OG003
value
21
group Id
OG004
value
30
group Id
OG005
value
7
units
Participants

description

groups

description
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
id
OG000
title
Part A
description
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
id
OG001
title
Part B
description
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
id
OG002
title
Part C
description
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
id
OG003
title
Part D
description
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
id
OG004
title
Part E
description
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
id
OG005
title
Part F

param Type

COUNT_OF_PARTICIPANTS

population Description

All subjects who received at least one dose of study drug

reporting Status

POSTED

time Frame

Up to 30 months

title

Number of Participants With Laboratory Abnormalities

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice