NCT01780662 · OUTCOME

Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma · Source last updated 2021-10-28

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: 13 months from first dose

What was measured

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

Analysis population: All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

Groups in this outcome

Dose 1.4mg/kg (Phase I)

Patients who were enrolled in Phase I and took dose 1.4mg/kg

Dose 1.8mg/kg (Phase I + Phase II)

Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg

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
Dose 1.4mg/kg (Phase I)	3
Dose 1.8mg/kg (Phase I + Phase II)	42

Reported measurements

Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Adrenal insufficiency

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	1	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	13	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	1	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	4	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	1	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	10	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Dental caries

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	3	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	2	Not reported	Not reported	Not reported	Not reported

GGT increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Hemolytic uremic syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	2	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	4	Not reported	Not reported	Not reported	Not reported

Infections and infestations - Other- Specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Investigations - Other- Specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	2	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	3	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	8	Not reported	Not reported	Not reported	Not reported

Myositis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	2	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	3	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	28	Not reported	Not reported	Not reported	Not reported

Non-cardiac chest pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Pain in extremity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Pericardial effusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	13	Not reported	Not reported	Not reported	Not reported

Pneumonitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	1	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	0	Not reported	Not reported	Not reported	Not reported

Pruritus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	1	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	0	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	3	Not reported	Not reported	Not reported	Not reported

Skin infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	1	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose 1.4mg/kg (Phase I)	3	Not reported	Not reported	Not reported	Not reported
Dose 1.8mg/kg (Phase I + Phase II)	15	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Abdominal pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Adrenal insufficiency
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
13
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Anorexia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
10
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Dehydration
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Dental caries
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
title
Diarrhea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Febrile neutropenia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
GGT increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Hemolytic uremic syndrome

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
42
units
Participants

description

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

groups

description
Patients who were enrolled in Phase I and took dose 1.4mg/kg
id
OG000
title
Dose 1.4mg/kg (Phase I)
description
Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
id
OG001
title
Dose 1.8mg/kg (Phase I + Phase II)

param Type

COUNT_OF_PARTICIPANTS

population Description

All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

reporting Status

POSTED

time Frame

13 months from first dose

title

Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice