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NCT01492088 · OUTCOME

Serum Concentration of Total Antibodies (Conjugated and Unconjugated)

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: ug/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

What was measured

Blood samples were collected and tested for conjugated and unconjugated antibodies.

Analysis population: PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.

Groups in this outcome

Brentuximab Vedotin 1.4 mg/kg: Phase 1

Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.

Brentuximab Vedotin 1.8 mg/kg: Phase 1

Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

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
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	33

Reported measurements

Cycle 1 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	32

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	NA	NA	Not reported	Not reported	Data was below the limit of quantification.
Brentuximab Vedotin 1.8 mg/kg: Phase 1	NA	NA	Not reported	Not reported	Data was below the limit of quantification.

Cycle 1 Day 1, 5 Minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	33

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	26.3	2.29	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	34.7	13.4	Not reported	Not reported	Not reported

Cycle 1 Day 2, 24 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	33

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	16.7	1.50	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	25.0	9.59	Not reported	Not reported	Not reported

Cycle 1 Day 3, 48 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	33

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	12.7	3.13	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	18.5	7.57	Not reported	Not reported	Not reported

Cycle 1 Day 5, 96 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	33

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	8.63	5.11	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	11.8	5.02	Not reported	Not reported	Not reported

Cycle 1 Day 14, 312 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	32

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2.23	0.833	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.50	1.70	Not reported	Not reported	Not reported

Cycle 2 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	32

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.470	0.459	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	1.16	0.825	Not reported	Not reported	Not reported

Cycle 2 Day 1, 5-minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	31

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	26.9	7.98	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	35.6	12.0	Not reported	Not reported	Not reported

Cycle 2 Day 2, 24 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	10

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	17.1	10.4	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17.2	7.93	Not reported	Not reported	Not reported

Cycle 2 Day 3, 48 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	31

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	9.60	5.39	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	16.0	6.73	Not reported	Not reported	Not reported

Cycle 2 Day 3, 96 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	30

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	6.43	3.69	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	10.2	5.16	Not reported	Not reported	Not reported

Cycle 3 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	26

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.415	0.586	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	1.62	1.07	Not reported	Not reported	Not reported

Cycle 3 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	26

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	30.0	5.87	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	38.2	13.1	Not reported	Not reported	Not reported

Cycle 4 Day 1, Pre-dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	21

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.875	1.03	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	1.95	1.26	Not reported	Not reported	Not reported

Cycle 4 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	21

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	29.6	8.13	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	37.1	15.6	Not reported	Not reported	Not reported

Cycle 5 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	21

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.844	0.928	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	2.45	1.68	Not reported	Not reported	Not reported

Cycle 5 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	21

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	29.4	3.04	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	38.0	18.8	Not reported	Not reported	Not reported

Cycle 6 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	1.05	1.20	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	2.99	1.81	Not reported	Not reported	Not reported

Cycle 6 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	29.4	5.37	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	39.8	19.8	Not reported	Not reported	Not reported

Cycle 7 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.995	0.998	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	2.92	1.62	Not reported	Not reported	Not reported

Cycle 7 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	24.0	2.69	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	41.0	21.2	Not reported	Not reported	Not reported

Cycle 8 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.29	1.14	Not reported	Not reported	Not reported

Cycle 8 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	41.4	9.47	Not reported	Not reported	Not reported

Cycle 8 Day 2, 24 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	28.2	6.38	Not reported	Not reported	Not reported

Cycle 8 Day 3, 48 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	22.9	5.67	Not reported	Not reported	Not reported

Cycle 8 Day 5, 96 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	17.3	4.93	Not reported	Not reported	Not reported

Cycle 8 Day 14, 312 Hours Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	13

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	5.74	2.02	Not reported	Not reported	Not reported

Cycle 9 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	14

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6.30	12.0	Not reported	Not reported	Not reported

Cycle 9 Day 1, 5 Minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	13

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	35.1	11.3	Not reported	Not reported	Not reported

Cycle 10 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	12

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.48	1.13	Not reported	Not reported	Not reported

Cycle 10 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	12

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	41.4	8.63	Not reported	Not reported	Not reported

Cycle 11 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	8

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.96	2.24	Not reported	Not reported	Not reported

Cycle 11 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	8

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	42.8	8.85	Not reported	Not reported	Not reported

Cycle 12 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.47	1.28	Not reported	Not reported	Not reported

Cycle 12 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	44.8	10.3	Not reported	Not reported	Not reported

Cycle 13 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	11.3	17.1	Not reported	Not reported	Not reported

Cycle 13 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	3
Brentuximab Vedotin 1.8 mg/kg: Phase 1	32

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	NA	NA	Not reported	Not reported	No participant was analyzed in this arm group at this time point.
Brentuximab Vedotin 1.8 mg/kg: Phase 1	40.3	19.2	Not reported	Not reported	Not reported

Cycle 14 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.97	1.14	Not reported	Not reported	Not reported

Cycle 14 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	44.5	7.05	Not reported	Not reported	Not reported

Cycle 15 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	4.02	1.40	Not reported	Not reported	Not reported

Cycle 15 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	49.7	6.88	Not reported	Not reported	Not reported

Cycle 16 Day 1, Pre-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	4.60	1.67	Not reported	Not reported	Not reported

Cycle 16 Day 1, 5 minutes Post-Dose

Analysis denominator · Participants

Group	Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	49.7	7.61	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Data was below the limit of quantification.
group Id
OG000
spread
NA
value
NA
comment
Data was below the limit of quantification.
group Id
OG001
spread
NA
value
NA
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 1, Pre-Dose
categories
measurements
group Id
OG000
spread
2.29
value
26.3
group Id
OG001
spread
13.4
value
34.7
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 1, 5 Minutes Post-Dose
categories
measurements
group Id
OG000
spread
1.50
value
16.7
group Id
OG001
spread
9.59
value
25.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
3.13
value
12.7
group Id
OG001
spread
7.57
value
18.5
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
5.11
value
8.63
group Id
OG001
spread
5.02
value
11.8
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 5, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.833
value
2.23
group Id
OG001
spread
1.70
value
3.50
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 14, 312 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.459
value
0.470
group Id
OG001
spread
0.825
value
1.16
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 2 Day 1, Pre-Dose
categories
measurements
group Id
OG000
spread
7.98
value
26.9
group Id
OG001
spread
12.0
value
35.6
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 2 Day 1, 5-minutes Post-Dose
categories
measurements
group Id
OG000
spread
10.4
value
17.1
group Id
OG001
spread
7.93
value
17.2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
10
units
Participants
title
Cycle 2 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
5.39
value
9.60
group Id
OG001
spread
6.73
value
16.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 2 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
3.69
value
6.43
group Id
OG001
spread
5.16
value
10.2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
30
units
Participants
title
Cycle 2 Day 3, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.586
value
0.415
group Id
OG001
spread
1.07
value
1.62
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
26
units
Participants
title
Cycle 3 Day 1, Pre-Dose

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants

description

Blood samples were collected and tested for conjugated and unconjugated antibodies.

dispersion Type

Standard Deviation

groups

description
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
id
OG000
title
Brentuximab Vedotin 1.4 mg/kg: Phase 1
description
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
id
OG001
title
Brentuximab Vedotin 1.8 mg/kg: Phase 1

param Type

MEAN

population Description

PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.

reporting Status

POSTED

time Frame

Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose

title

Serum Concentration of Total Antibodies (Conjugated and Unconjugated)

type

SECONDARY

unit Of Measure

ug/mL

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Preserved source evidence · Not medical advice