Trial Outcomes & Findings for A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT01990534)
NCT ID: NCT01990534
Last Updated: 2021-04-09
Results Overview
Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Baseline until disease progression, death or end of study (EOS) (Up to 24 months)
Results posted on
2021-04-09
Participant Flow
Participants took part in the study at 18 investigative sites in Czech Republic, Germany, Malaysia, Poland, Spain, Thailand and Turkey, from 14 March 2014 to 12 March 2020.
Participants with a diagnosis of relapsed or refractory Hodgkin Lymphoma were enrolled in 1 treatment group to receive brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion on Day 1 of every 3-week cycle and were followed for progression free survival (PFS) and overall survival (OS) up to the End of study (approximately 6 years).
Participant milestones
| Measure |
Brentuximab Vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Brentuximab Vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Overall Study
Death
|
22
|
|
Overall Study
Progressive disease
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal of Informed Consent
|
2
|
|
Overall Study
Symptomatic Deterioration
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Reason not Specified
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 13.83 • n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Czech Republic
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Malaysia
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
26 Participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Thailand
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
Turkey
|
9 Participants
n=93 Participants
|
|
Baseline Height
|
171.0 cm
STANDARD_DEVIATION 9.66 • n=93 Participants
|
|
Baseline Weight
|
70.3 kg
STANDARD_DEVIATION 19.41 • n=93 Participants
|
|
Body Mass Index (BMI)
|
23.864 kg/m^2
STANDARD_DEVIATION 5.4085 • n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression, death or end of study (EOS) (Up to 24 months)Population: Intent-to-Treat (ITT) Population included all participants who were enrolled in the study.
Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Objective Response Rate (ORR)
|
50 percentage of participants
Interval 37.0 to 63.0
|
SECONDARY outcome
Timeframe: From first documented complete or partial remission until disease progression (Up to 24 months)Population: ITT Population included all participants who were enrolled in the study. DOR was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplantation (SCT), or discontinued treatment due to undocumented PD after last disease assessment. All responders were evaluated in this outcome measure.
DOR is defined as the time in months from the date of first documentation of a CR or PR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=30 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Duration of Response (DOR)
|
4.6 months
Interval 3.42 to 7.85
|
SECONDARY outcome
Timeframe: Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 yearsPopulation: ITT Population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.
PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.8 months
Interval 2.96 to 5.32
|
SECONDARY outcome
Timeframe: Baseline until disease progression, death or EOS (Up to approximately 6 years)Population: ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.
Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Complete Remission Rate
|
13 percentage of participants
Interval 6.0 to 25.0
|
SECONDARY outcome
Timeframe: From first documented complete remission until disease progression (up to approximately 6 years)Population: ITT Population included all participants who were enrolled in the study. Duration of complete remission was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than SCT, or discontinued treatment due to undocumented PD after last disease assessment. Only participants with CR were analyzed for this outcome measure.
Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=8 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Duration of Complete Remission
|
6.1 months
Interval 2.1 to
Upper limit of CI was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years)Population: ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.
OS is the time in months from start of study treatment to date of death due to any cause.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Median and 95% confidence interval (CI) was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline up to EOS (up to approximately 6 years)Population: ITT Population included all participants who were enrolled in the study.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Percentage of Participants Who Received Hematopoietic SCT
|
53 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose through 30 days after the last dose of study medication (Up to 24 months)Population: Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE a serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
Any AEs
|
52 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
Grade 3 or higher AEs
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
Drug-related AEs
|
41 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
Drug-related Grade 3 or higher AEs
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
SAEs
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
Drug-related SAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first dose through 30 days after the last dose of study medication (Up to 24 months)Population: Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Neutrophil count decreased
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Lymphocyte count decreased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Alanine aminotransferase increased
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Aspartate aminotransferase increased
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Gamma-glutamyltransferase increased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Blood thyroid stimulating hormone increased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Platelet count decreased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Haemoglobin decreased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Blood alkaline phosphatase increased
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs
Blood lactate dehydrogenase increased
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)Population: Pharmacokinetic (PK)-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point.
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 1 Day 1, Pre-Dose
|
0.00 ng/mL
Standard Deviation 0.000
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 1 Day 1, 10 minutes Post-Dose
|
35504.65 ng/mL
Standard Deviation 10226.104
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 1 Day 2, 24 hours Post-Dose
|
14517.67 ng/mL
Standard Deviation 4481.312
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 1 Day 15, 336 hours Post-Dose
|
1410.43 ng/mL
Standard Deviation 1946.525
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 2 Day 1, Pre-Dose
|
526.42 ng/mL
Standard Deviation 350.467
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 2 Day 1, 10 minutes Post-Dose
|
37118.32 ng/mL
Standard Deviation 11678.088
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 3 Day 1, Pre-Dose
|
2283.30 ng/mL
Standard Deviation 7552.322
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 3 Day 1, 10 minutes Post-Dose
|
35878.77 ng/mL
Standard Deviation 12724.898
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 3 Day 2, 24 hours Post-Dose
|
14737.82 ng/mL
Standard Deviation 4512.358
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 3 Day 15, 336 hours Post-Dose
|
1586.45 ng/mL
Standard Deviation 680.955
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 4 Day 1, Pre-Dose
|
1313.56 ng/mL
Standard Deviation 2566.360
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 4 Day 1, 10 minutes Post-Dose
|
42915.34 ng/mL
Standard Deviation 28221.764
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 5 Day 1, Pre-Dose
|
1117.01 ng/mL
Standard Deviation 637.637
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 5 Day 1, 10 minutes Post-Dose
|
36418.77 ng/mL
Standard Deviation 10041.935
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 6 Day 1, Pre-Dose
|
1231.45 ng/mL
Standard Deviation 714.383
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 6 Day 1, 10 minutes Post-Dose
|
39000.95 ng/mL
Standard Deviation 12484.458
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 7 Day 1, Pre-Dose
|
1285.91 ng/mL
Standard Deviation 712.625
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 7 Day 1, 10 minutes Post-Dose
|
38814.82 ng/mL
Standard Deviation 12471.299
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 8 Day 1, Pre-Dose
|
1413.98 ng/mL
Standard Deviation 782.391
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 8 Day 1, 10 minutes Post-Dose
|
39027.22 ng/mL
Standard Deviation 9919.251
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 9 Day 1, Pre-Dose
|
1277.18 ng/mL
Standard Deviation 594.603
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 9 Day 1, 10 minutes Post-Dose
|
38359.15 ng/mL
Standard Deviation 13421.064
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 10 Day 1, Pre-Dose
|
1498.44 ng/mL
Standard Deviation 754.721
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 10 Day 1, 10 minutes Post-Dose
|
39890.12 ng/mL
Standard Deviation 5376.038
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 11 Day 1, Pre-Dose
|
1511.35 ng/mL
Standard Deviation 461.907
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 11 Day 1, 10 minutes Post-Dose
|
39132.17 ng/mL
Standard Deviation 6316.541
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 12 Day 1, Pre-Dose
|
1479.38 ng/mL
Standard Deviation 397.816
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 12 Day 1, 10 minutes Post-Dose
|
39955.13 ng/mL
Standard Deviation 7821.656
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 13 Day 1, Pre-Dose
|
1423.56 ng/mL
Standard Deviation 415.744
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 13 Day 1, 10 minutes Post-Dose
|
37609.69 ng/mL
Standard Deviation 4563.601
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 14 Day 1, Pre-Dose
|
1185.62 ng/mL
Standard Deviation 422.664
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 14 Day 1, 10 minutes Post-Dose
|
38282.29 ng/mL
Standard Deviation 10324.023
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 15 Day 1, Pre-Dose
|
2279.42 ng/mL
Standard Deviation 2919.545
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 15 Day 1, 10 minutes Post-Dose
|
39068.14 ng/mL
Standard Deviation 7981.110
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 16 Day 1, Pre-Dose
|
1452.23 ng/mL
Standard Deviation 429.731
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
Cycle 16 Day 1, 10 minutes Post-Dose
|
38414.73 ng/mL
Standard Deviation 9427.315
|
|
Antibody-drug Conjugate (ADC) Serum Concentrations
End of Treatment
|
1515.30 ng/mL
Standard Deviation 6413.367
|
SECONDARY outcome
Timeframe: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)Population: PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point.
Blood samples were collected and tested for conjugated and unconjugated antibodies.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 1 Day 1, Pre-Dose
|
0.00 ng/mL
Standard Deviation 0.000
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 1 Day 1, 10 minutes Post-Dose
|
37329.59 ng/mL
Standard Deviation 17724.247
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 1 Day 2, 24 hours Post-Dose
|
23248.90 ng/mL
Standard Deviation 8228.938
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 1 Day 15, 336 hours Post-Dose
|
2791.49 ng/mL
Standard Deviation 1413.452
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 2 Day 1, Pre-Dose
|
1254.86 ng/mL
Standard Deviation 774.586
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 2 Day 1, 10 minutes Post-Dose
|
39801.87 ng/mL
Standard Deviation 12914.837
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 3 Day 1, Pre-Dose
|
2645.22 ng/mL
Standard Deviation 5685.914
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 3 Day 1, 10 minutes Post-Dose
|
36461.28 ng/mL
Standard Deviation 11144.634
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 3 Day 2, 24 hours Post-Dose
|
27071.46 ng/mL
Standard Deviation 8069.489
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 3 Day 15, 336 hours Post-Dose
|
4033.28 ng/mL
Standard Deviation 1760.094
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 4 Day 1, Pre-Dose\
|
2600.73 ng/mL
Standard Deviation 2275.881
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 4 Day 1, 10 minutes Post-Dose
|
41823.31 ng/mL
Standard Deviation 11761.223
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 5 Day 1, Pre-Dose
|
2690.61 ng/mL
Standard Deviation 1254.886
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 5 Day 1, 10 minutes Post-Dose
|
43786.57 ng/mL
Standard Deviation 15470.979
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 6 Day 1, Pre-Dose
|
2806.17 ng/mL
Standard Deviation 1021.877
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 6 Day 1, 10 minutes Post-Dose
|
44936.89 ng/mL
Standard Deviation 13827.929
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 7 Day 1, Pre-Dose
|
3889.94 ng/mL
Standard Deviation 6201.351
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 7 Day 1, 10 minutes Post-Dose
|
41840.20 ng/mL
Standard Deviation 12552.597
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 8 Day 1, Pre-Dose
|
2932.19 ng/mL
Standard Deviation 1089.138
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 8 Day 1, 10 minutes Post-Dose
|
42013.77 ng/mL
Standard Deviation 12754.334
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 9 Day 1, Pre-Dose
|
2959.26 ng/mL
Standard Deviation 970.811
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 9 Day 1, 10 minutes Post-Dose
|
37300.95 ng/mL
Standard Deviation 13442.910
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 10 Day 1, Pre-Dose
|
3189.16 ng/mL
Standard Deviation 1484.258
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 10 Day 1, 10 minutes Post-Dose
|
38910.05 ng/mL
Standard Deviation 6169.552
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 11 Day 1, Pre-Dose
|
3393.07 ng/mL
Standard Deviation 1160.604
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 11 Day 1, 10 minutes Post-Dose
|
41238.25 ng/mL
Standard Deviation 8081.750
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 12 Day 1, Pre-Dose
|
3270.44 ng/mL
Standard Deviation 965.895
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 12 Day 1, 10 minutes Post-Dose
|
37550.64 ng/mL
Standard Deviation 12459.906
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 13 Day 1, Pre-Dose
|
3406.00 ng/mL
Standard Deviation 1067.414
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 13 Day 1, 10 minutes Post-Dose
|
35694.80 ng/mL
Standard Deviation 3720.378
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 14 Day 1, Pre-Dose
|
2723.01 ng/mL
Standard Deviation 1286.457
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 14 Day 1, 10 minutes Post-Dose
|
40848.64 ng/mL
Standard Deviation 8704.538
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 15 Day 1, Pre-Dose
|
3111.63 ng/mL
Standard Deviation 941.200
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 15 Day 1, 10 minutes Post-Dose
|
37091.56 ng/mL
Standard Deviation 6644.258
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 16 Day 1, Pre-Dose
|
3159.38 ng/mL
Standard Deviation 1017.679
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Cycle 16 Day 1, 10 minutes Post-Dose
|
39266.07 ng/mL
Standard Deviation 9358.163
|
|
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
End of Treatment
|
2340.49 ng/mL
Standard Deviation 6715.837
|
SECONDARY outcome
Timeframe: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)Population: PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point.
Blood samples were collected and tested for MMAE serum concentrations.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 1 Day 1, Pre-Dose
|
0.78 pg/mL
Standard Deviation 5.976
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 1 Day 1, 10 minutes Post-Dose
|
591.09 pg/mL
Standard Deviation 662.608
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 1 Day 2, 24 hours Post-Dose
|
6056.44 pg/mL
Standard Deviation 3850.457
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 1 Day 15, 336 hours Post-Dose
|
746.12 pg/mL
Standard Deviation 1123.502
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 2 Day 1, Pre-Dose
|
140.11 pg/mL
Standard Deviation 111.036
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 2 Day 1, 10 minutes Post-Dose
|
539.38 pg/mL
Standard Deviation 593.150
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 3 Day 1, Pre-Dose
|
130.62 pg/mL
Standard Deviation 84.152
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 3 Day 1, 10 minutes Post-Dose
|
484.88 pg/mL
Standard Deviation 701.402
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 3 Day 2, 24 hours Post-Dose
|
3076.75 pg/mL
Standard Deviation 2330.510
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 3 Day 15, 336 hours Post-Dose
|
442.63 pg/mL
Standard Deviation 259.360
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 4 Day 1, Pre-Dose
|
150.95 pg/mL
Standard Deviation 123.841
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 4 Day 1, 10 minutes Post-Dose
|
497.20 pg/mL
Standard Deviation 520.110
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 5 Day 1, Pre-Dose
|
153.95 pg/mL
Standard Deviation 123.337
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 5 Day 1, 10 minutes Post-Dose
|
392.50 pg/mL
Standard Deviation 320.346
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 6 Day 1, Pre-Dose
|
158.89 pg/mL
Standard Deviation 109.024
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 6 Day 1, 10 minutes Post-Dose
|
369.53 pg/mL
Standard Deviation 260.871
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 7 Day 1, Pre-Dose
|
185.91 pg/mL
Standard Deviation 147.311
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 7 Day 1, 10 minutes Post-Dose
|
363.83 pg/mL
Standard Deviation 237.883
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 8 Day 1, Pre-Dose
|
136.37 pg/mL
Standard Deviation 86.947
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 8 Day 1, 10 minutes Post-Dose
|
303.43 pg/mL
Standard Deviation 202.351
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 9 Day 1, Pre-Dose
|
142.30 pg/mL
Standard Deviation 114.794
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 9 Day 1, 10 minutes Post-Dose
|
224.52 pg/mL
Standard Deviation 159.833
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 10 Day 1, Pre-Dose
|
100.78 pg/mL
Standard Deviation 57.270
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 10 Day 1, 10 minutes Post-Dose
|
253.73 pg/mL
Standard Deviation 113.311
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 11 Day 1, Pre-Dose
|
158.09 pg/mL
Standard Deviation 169.963
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 11 Day 1, 10 minutes Post-Dose
|
302.60 pg/mL
Standard Deviation 175.869
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 12 Day 1, Pre-Dose
|
175.02 pg/mL
Standard Deviation 141.192
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 12 Day 1, 10 minutes Post-Dose
|
382.52 pg/mL
Standard Deviation 428.255
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 13 Day 1, Pre-Dose
|
146.76 pg/mL
Standard Deviation 61.758
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 13 Day 1, 10 minutes Post-Dose
|
258.78 pg/mL
Standard Deviation 108.871
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 14 Day 1, Pre-Dose
|
82.13 pg/mL
Standard Deviation 22.661
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 14 Day 1, 10 minutes Post-Dose
|
204.29 pg/mL
Standard Deviation 121.162
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 15 Day 1, Pre-Dose
|
133.78 pg/mL
Standard Deviation 59.213
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 15 Day 1, 10 minutes Post-Dose
|
246.63 pg/mL
Standard Deviation 98.399
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 16 Day 1, Pre-Dose
|
163.39 pg/mL
Standard Deviation 114.821
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
Cycle 16 Day 1, 10 minutes Post-Dose
|
264.63 pg/mL
Standard Deviation 103.269
|
|
Monomethyl Auristatin E (MMAE) Serum Concentrations
End of Treatment
|
139.72 pg/mL
Standard Deviation 220.211
|
SECONDARY outcome
Timeframe: Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 24 months)Population: Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.
Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers.
Outcome measures
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=56 Participants
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
ATA Positive
|
21 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Transient Positive
|
17 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
Persistently Positive
|
4 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
ATA Titer Low (≤25)
|
21 Participants
|
|
Number of Participants With Antitherapeutic Antibodies (ATA)
ATA Titer High (>25)
|
0 Participants
|
Adverse Events
Brentuximab Vedotin 1.8 mg/kg
Serious events: 11 serious events
Other events: 51 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 participants at risk
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related sepsis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic shock
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Dengue fever
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Serum sickness-like reaction
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
General physical health deterioration
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Brentuximab Vedotin 1.8 mg/kg
n=60 participants at risk
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
5/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
6/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Diplopia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
6/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
5/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site inflammation
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Extravasation
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
18.3%
11/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Soft tissue inflammation
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Temperature regulation disorder
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vaccination site pain
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Breast cellulitis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Coxsackie viral infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Dengue fever
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hordeolum
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Klebsiella infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
5/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
4/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
4/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Autonomic neuropathy
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Facial nerve disorder
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
6/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.7%
7/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
8.3%
5/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal tubular disorder
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
3/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Lymphoedema
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.7%
1/60 • First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER