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NCT01492088 · OUTCOME

Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)

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: ng/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 MMAE plasma concentrations.

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 ng/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	32

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.416	0.480	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.368	0.309	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	32

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	4.63	3.20	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	4.88	3.55	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	32

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	4.20	1.95	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	5.36	3.72	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	32

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2.80	0.300	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	4.43	3.04	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	31

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.196	0.0641	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.530	0.552	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	29

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.0647	0.0358	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0739	0.0640	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	29

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.556	0.562	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.478	0.461	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	8

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	5.63	5.72	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.71	3.94	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	30

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	4.60	3.70	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	3.86	3.18	Not reported	Not reported	Not reported

Cycle 2 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	29

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	2.60	1.04	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	2.70	1.69	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.0250	0.0354	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0650	0.0590	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	25

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.216	0.0361	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.514	0.684	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	19

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.0565	0.00495	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0866	0.0784	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	19

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.234	0.0742	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.376	0.449	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	18

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.0820	NA	Not reported	Not reported	Standard deviation was not estimable for 2 participants.
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0862	0.0729	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	18

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.334	0.0955	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.301	0.248	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	15

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.0680	0.0156	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0841	0.0632	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	15

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.247	0.00707	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.450	0.663	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	16

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.104	0.0389	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0830	0.0578	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	15

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1	0.326	0.0361	Not reported	Not reported	Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.310	0.282	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	13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.101	0.934	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	12

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.295	0.151	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	13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	1.96	1.31	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	13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	1.91	1.29	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	13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	2.00	1.05	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	12

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.325	0.214	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	13

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0819	0.0496	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	12

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.218	0.128	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.727	0.0517	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.204	0.0982	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	7

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0763	0.0368	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	7

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.255	0.133	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	5

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.105	0.0983	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	5

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.252	0.116	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.110	0.0629	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	0
Brentuximab Vedotin 1.8 mg/kg: Phase 1	6

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.244	0.130	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.109	0.0529	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.320	0.138	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.0843	0.0548	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.404	0.192	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.139	0.0926	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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1	0.381	0.277	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
0.480
value
0.416
group Id
OG001
spread
0.309
value
0.368
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 1, 5 Minutes Post-Dose
categories
measurements
group Id
OG000
spread
3.20
value
4.63
group Id
OG001
spread
3.55
value
4.88
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
1.95
value
4.20
group Id
OG001
spread
3.72
value
5.36
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.300
value
2.80
group Id
OG001
spread
3.04
value
4.43
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 5, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.0641
value
0.196
group Id
OG001
spread
0.552
value
0.530
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 1 Day 14, 312 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.0358
value
0.0647
group Id
OG001
spread
0.0640
value
0.0739
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
29
units
Participants
title
Cycle 2 Day 1, Pre-Dose
categories
measurements
group Id
OG000
spread
0.562
value
0.556
group Id
OG001
spread
0.461
value
0.478
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
29
units
Participants
title
Cycle 2 Day 1, 5-minutes Post-Dose
categories
measurements
group Id
OG000
spread
5.72
value
5.63
group Id
OG001
spread
3.94
value
3.71
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
8
units
Participants
title
Cycle 2 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
3.70
value
4.60
group Id
OG001
spread
3.18
value
3.86
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
30
units
Participants
title
Cycle 2 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
1.04
value
2.60
group Id
OG001
spread
1.69
value
2.70
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
29
units
Participants
title
Cycle 2 Day 5, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.0354
value
0.0250
group Id
OG001
spread
0.0590
value
0.0650
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 MMAE plasma concentrations.

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

Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice