Trial Outcomes & Findings for Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies (NCT NCT01461538)
NCT ID: NCT01461538
Last Updated: 2016-03-04
Results Overview
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2016-03-04
Participant Flow
Oct 2011 - Dec 2014
One additional patient enrolled, but withdrew prior to treatment group assignment.
Participant milestones
| Measure |
BV 1.8 mg/kg Q3Week
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 2.4 mg/kg Q3Week
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
28
|
9
|
|
Overall Study
COMPLETED
|
28
|
20
|
7
|
|
Overall Study
NOT COMPLETED
|
18
|
8
|
2
|
Reasons for withdrawal
| Measure |
BV 1.8 mg/kg Q3Week
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 2.4 mg/kg Q3Week
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Overall Study
Death
|
15
|
6
|
2
|
|
Overall Study
Study Stopped by Sponsor
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Baseline characteristics by cohort
| Measure |
BV 1.8 mg/kg Q3Week
n=46 Participants
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 2.4 mg/kg Q3Week
n=28 Participants
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
64 years
n=107 Participants
|
76 years
n=206 Participants
|
65 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
28 participants
n=107 Participants
|
9 participants
n=206 Participants
|
83 participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0
|
13 participants
n=99 Participants
|
5 participants
n=107 Participants
|
1 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1
|
20 participants
n=99 Participants
|
15 participants
n=107 Participants
|
5 participants
n=206 Participants
|
40 participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
3-5
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Missing
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
2 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Height
|
170.2 centimeters (cm)
n=99 Participants
|
171.9 centimeters (cm)
n=107 Participants
|
167.6 centimeters (cm)
n=206 Participants
|
170.2 centimeters (cm)
n=7 Participants
|
|
Weight
|
74.8 kilograms (kg)
n=99 Participants
|
75.1 kilograms (kg)
n=107 Participants
|
73.4 kilograms (kg)
n=206 Participants
|
74.8 kilograms (kg)
n=7 Participants
|
|
Body Mass Index
|
25.3 kg per meter squared (kg/m^2)
n=99 Participants
|
27.4 kg per meter squared (kg/m^2)
n=107 Participants
|
26.3 kg per meter squared (kg/m^2)
n=206 Participants
|
26.0 kg per meter squared (kg/m^2)
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: Efficacy-evaluable population
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Outcome measures
| Measure |
Solid Tumors
n=59 Participants
Participants with solid tumors
|
Leukemia
n=14 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Objective Response Rate (ORR) by Investigator
|
12 percentage of participants
Interval 4.9 to 22.9
|
14 percentage of participants
Interval 1.8 to 42.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: Efficacy-evaluable population
Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Outcome measures
| Measure |
Solid Tumors
n=59 Participants
Participants with solid tumors
|
Leukemia
n=14 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Complete Remission (CR) Rate by Investigator
|
2 percentage of participants
Interval 0.0 to 9.1
|
0 percentage of participants
Interval 0.0 to 23.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: Participants with objective response (CR \[+CRi; leukemia\] + PR)
Duration of objective response (CR \[+CRi; leukemia\] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Outcome measures
| Measure |
Solid Tumors
n=7 Participants
Participants with solid tumors
|
Leukemia
n=2 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Duration of Objective Response by Kaplan-Meier Analysis
|
2.9 months
Interval 1.5 to 23.5
|
2.1 months
Interval 1.0 to 3.1
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: Participants with CR
Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Outcome measures
| Measure |
Solid Tumors
n=1 Participants
Participants with solid tumors
|
Leukemia
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Duration of Complete Response by Kaplan-Meier Analysis
|
22.3 months
Interval 22.3 to 22.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All treated patients, excluding 3 patients without available response results
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Outcome measures
| Measure |
Solid Tumors
n=63 Participants
Participants with solid tumors
|
Leukemia
n=17 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Progression-Free Survival by Kaplan-Meier Analysis
|
2.1 months
Interval 1.3 to 2.8
|
0.7 months
Interval 0.7 to 1.3
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Outcome measures
| Measure |
Solid Tumors
n=46 Participants
Participants with solid tumors
|
Leukemia
n=28 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Any TEAE
|
45 participants
|
28 participants
|
9 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
TEAE related to study drug
|
31 participants
|
24 participants
|
5 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
TEAE with severity grade >/=3
|
31 participants
|
18 participants
|
7 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Discontinued treatment due to adverse event
|
5 participants
|
2 participants
|
2 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Serious adverse event
|
24 participants
|
13 participants
|
5 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Serious adverse event related to study drug
|
5 participants
|
6 participants
|
2 participants
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Deaths (within 30 days of last dose)
|
10 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients
Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category
Outcome measures
| Measure |
Solid Tumors
n=46 Participants
Participants with solid tumors
|
Leukemia
n=28 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Laboratory Abnormalities >/= Grade 3
Any >/= Grade 3 laboratory abnormality
|
24 participants
|
12 participants
|
9 participants
|
|
Laboratory Abnormalities >/= Grade 3
Alanine aminotransferase high
|
0 participants
|
1 participants
|
1 participants
|
|
Laboratory Abnormalities >/= Grade 3
Albumin low
|
2 participants
|
3 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Alkaline phosphatase high
|
0 participants
|
1 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Aspartate aminotransferase high
|
0 participants
|
1 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Bilirubin high
|
0 participants
|
1 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Calcium low
|
1 participants
|
1 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Glucose high
|
2 participants
|
1 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Glucose low
|
1 participants
|
0 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Sodium low
|
4 participants
|
2 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Urate high
|
2 participants
|
0 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Prothrombin INR high
|
0 participants
|
0 participants
|
1 participants
|
|
Laboratory Abnormalities >/= Grade 3
Absolute neutrophil count low
|
6 participants
|
2 participants
|
5 participants
|
|
Laboratory Abnormalities >/= Grade 3
Hemoglobin low
|
4 participants
|
0 participants
|
3 participants
|
|
Laboratory Abnormalities >/= Grade 3
Leukocytes high
|
0 participants
|
1 participants
|
1 participants
|
|
Laboratory Abnormalities >/= Grade 3
Leukocytes low
|
4 participants
|
0 participants
|
4 participants
|
|
Laboratory Abnormalities >/= Grade 3
Lymphocytes high
|
1 participants
|
2 participants
|
0 participants
|
|
Laboratory Abnormalities >/= Grade 3
Lymphocytes low
|
9 participants
|
3 participants
|
1 participants
|
|
Laboratory Abnormalities >/= Grade 3
Neutrophils low
|
6 participants
|
3 participants
|
7 participants
|
|
Laboratory Abnormalities >/= Grade 3
Platelets low
|
4 participants
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients with available ADC Ceoi results
Outcome measures
| Measure |
Solid Tumors
n=42 Participants
Participants with solid tumors
|
Leukemia
n=25 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
|
40 ug/mL
Geometric Coefficient of Variation 26
|
54 ug/mL
Geometric Coefficient of Variation 28
|
25 ug/mL
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients with available ADC Ctrough results
Outcome measures
| Measure |
Solid Tumors
n=34 Participants
Participants with solid tumors
|
Leukemia
n=10 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
|
0.36 ug/mL
Geometric Coefficient of Variation 180
|
0.55 ug/mL
Geometric Coefficient of Variation 210
|
1.5 ug/mL
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients with available Cmax of MMAE results
Outcome measures
| Measure |
Solid Tumors
n=43 Participants
Participants with solid tumors
|
Leukemia
n=25 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
|
4.0 ng/mL
Geometric Coefficient of Variation 78
|
6.2 ng/mL
Geometric Coefficient of Variation 71
|
2.6 ng/mL
Geometric Coefficient of Variation 83
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All treated patients with available MMAE Ctrough results
Outcome measures
| Measure |
Solid Tumors
n=34 Participants
Participants with solid tumors
|
Leukemia
n=11 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=9 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
|
0.22 ng/mL
Geometric Coefficient of Variation 92
|
0.35 ng/mL
Geometric Coefficient of Variation 82
|
1.5 ng/mL
Geometric Coefficient of Variation 65
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: Immunogenicity-evaluable set
Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.
Outcome measures
| Measure |
Solid Tumors
n=36 Participants
Participants with solid tumors
|
Leukemia
n=23 Participants
Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
|
BV 1.2 mg/kg Q1Week
n=8 Participants
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Incidence of Anti-therapeutic Antibodies (ATA)
Baseline (BL) negative
|
33 participants
|
21 participants
|
8 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL negative, negative post-BL
|
14 participants
|
14 participants
|
8 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL negative, transiently positive post-BL
|
18 participants
|
6 participants
|
0 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL negative, persistently positive post-BL
|
1 participants
|
1 participants
|
0 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL positive
|
3 participants
|
2 participants
|
0 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL positive, negative post-BL
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL positive, transiently positive post-BL
|
2 participants
|
1 participants
|
0 participants
|
|
Incidence of Anti-therapeutic Antibodies (ATA)
BL positive, persistently positive post-BL
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
BV 1.8 mg/kg Q3Week
Serious events: 24 serious events
Other events: 42 other events
Deaths: 0 deaths
BV 2.4 mg/kg Q3Week
Serious events: 13 serious events
Other events: 28 other events
Deaths: 0 deaths
BV 1.2 mg/kg Q1Week
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BV 1.8 mg/kg Q3Week
n=46 participants at risk
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 2.4 mg/kg Q3Week
n=28 participants at risk
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 1.2 mg/kg Q1Week
n=9 participants at risk
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Systemic mastocytosis
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Atrial flutter
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Cardiac arrest
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Abdominal hernia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Fatigue
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Diverticulitis
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Escherichia sepsis
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Pneumonia
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Sepsis
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Erythroleukemia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Seizure
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Renal and urinary disorders
Azotemia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Renal and urinary disorders
Renal tubular necrosis
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Vascular disorders
Lymphoedema
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
Other adverse events
| Measure |
BV 1.8 mg/kg Q3Week
n=46 participants at risk
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 2.4 mg/kg Q3Week
n=28 participants at risk
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
|
BV 1.2 mg/kg Q1Week
n=9 participants at risk
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
19.6%
9/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
25.0%
7/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Diarrhea
|
30.4%
14/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
17.9%
5/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
22.2%
2/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Dizziness
|
10.9%
5/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Headache
|
10.9%
5/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.9%
5/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.4%
8/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
25.0%
7/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Psychiatric disorders
Anxiety
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Psychiatric disorders
Delirium
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Nausea
|
28.3%
13/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
39.3%
11/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Vomiting
|
23.9%
11/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
25.0%
7/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Asthenia
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Chest pain
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Chills
|
13.0%
6/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Fatigue
|
56.5%
26/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
35.7%
10/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
33.3%
3/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Malaise
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Edema peripheral
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
21.4%
6/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Pain
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
22.2%
2/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
General disorders
Pyrexia
|
13.0%
6/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Bronchitis
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Skin infection
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Investigations
Weight decreased
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.9%
11/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
32.1%
9/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
22.2%
2/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
22.2%
2/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
4/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
17.9%
5/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
6/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
44.4%
4/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
33.3%
3/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Cardiac disorders
Tachycardia
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Abdominal pain
|
10.9%
5/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Gastrointestinal disorders
Ascites
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Psychiatric disorders
Insomnia
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
5/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
8/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
21.4%
6/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
33.3%
3/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
2/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
3.6%
1/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
7.1%
2/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.0%
6/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
25.0%
7/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
22.2%
2/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
3/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
6/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
25.0%
7/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
8/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
10.7%
3/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
11.1%
1/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
|
Vascular disorders
Flushing
|
2.2%
1/46 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
14.3%
4/28 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
0.00%
0/9 • Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60