Trial Outcomes & Findings for A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma (NCT NCT01950364)
NCT ID: NCT01950364
Last Updated: 2016-05-11
Results Overview
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Cycle 1: Predose
Results posted on
2016-05-11
Participant Flow
Participants took part in the study at 5 investigative sites in Belgium, Lithuania and Spain from 27 November 2013 to 16 June 2015.
Participants with a historical diagnosis of relapsed or refractory classical hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were enrolled in 1 of 2 treatment groups: Brentuximab vedotin; Brentuximab vedotin + Rifampicin.
Participant milestones
| Measure |
Brentuximab Vedotin
Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
Brentuximab Vedotin + Rifampicin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Brentuximab Vedotin
Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
Brentuximab Vedotin + Rifampicin
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Stem Cell Transplant
|
2
|
6
|
|
Overall Study
Disease Progression
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
Brentuximab Vedotin + Rifampicin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 12.15 • n=39 Participants
|
40.1 years
STANDARD_DEVIATION 9.13 • n=41 Participants
|
41.2 years
STANDARD_DEVIATION 10.52 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
20 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
20 participants
n=35 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=39 Participants
|
5 participants
n=41 Participants
|
9 participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=39 Participants
|
1 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Region of Enrollment
Lithuania
|
4 participants
n=39 Participants
|
4 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Weight
|
71.11 kilogram (kg)
STANDARD_DEVIATION 17.056 • n=39 Participants
|
76.84 kilogram (kg)
STANDARD_DEVIATION 24.213 • n=41 Participants
|
73.98 kilogram (kg)
STANDARD_DEVIATION 20.595 • n=35 Participants
|
|
Height
|
169.9 centimeter (cm)
STANDARD_DEVIATION 3.80 • n=39 Participants
|
169.7 centimeter (cm)
STANDARD_DEVIATION 6.45 • n=41 Participants
|
169.8 centimeter (cm)
STANDARD_DEVIATION 5.15 • n=35 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
3 participants
n=39 Participants
|
6 participants
n=41 Participants
|
9 participants
n=35 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
6 participants
n=39 Participants
|
4 participants
n=41 Participants
|
10 participants
n=35 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Disease Type
Hodgkin lymphoma
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
20 participants
n=35 Participants
|
|
Disease Type
sALCL
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
|
Months from Initial Diagnosis to First Dose
|
34.7 months
STANDARD_DEVIATION 31.23 • n=39 Participants
|
61.9 months
STANDARD_DEVIATION 46.96 • n=41 Participants
|
48.3 months
STANDARD_DEVIATION 41.25 • n=35 Participants
|
|
Ann Arbor Stage
I
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Ann Arbor Stage
II
|
2 participants
n=39 Participants
|
6 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Ann Arbor Stage
III
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Ann Arbor Stage
IV
|
6 participants
n=39 Participants
|
4 participants
n=41 Participants
|
10 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Cycle 1: PredosePopulation: Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
MMAE
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 2: PredosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
MMAE
|
0.0795 ng/mL
Standard Deviation 0.14220
|
0.0919 ng/mL
Standard Deviation 0.05695
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: PredosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
MMAE
|
0.0727 ng/mL
Standard Deviation 0.05936
|
0.1046 ng/mL
Standard Deviation 0.10840
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: 0.5 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
MMAE
|
0.2149 ng/mL
Standard Deviation 0.43900
|
0.3902 ng/mL
Standard Deviation 1.33635
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0184 ng/mL
Standard Deviation 0.00613
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0267 ng/mL
Standard Deviation 0.02119
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0108 ng/mL
Standard Deviation 0.00360
|
PRIMARY outcome
Timeframe: Cycle 2: 0.5 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
MMAE
|
0.2929 ng/mL
Standard Deviation 1.39185
|
0.3119 ng/mL
Standard Deviation 1.69249
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
C8
|
0.0228 ng/mL
Standard Deviation 0.00760
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 0.5 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
MMAE
|
0.2577 ng/mL
Standard Deviation 0.26736
|
0.3307 ng/mL
Standard Deviation 2.33539
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0256 ng/mL
Standard Deviation 0.00905
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0323 ng/mL
Standard Deviation 0.03266
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0210 ng/mL
Standard Deviation 0.00742
|
PRIMARY outcome
Timeframe: Cycle 1: 4 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
MMAE
|
1.7836 ng/mL
Standard Deviation 0.93129
|
2.2778 ng/mL
Standard Deviation 4.42089
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0547 ng/mL
Standard Deviation 0.02737
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0254 ng/mL
Standard Deviation 0.01326
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0195 ng/mL
Standard Deviation 0.01293
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
C8
|
0.0160 ng/mL
Standard Deviation 0.00921
|
0.0557 ng/mL
Standard Deviation 0.05631
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0151 ng/mL
Standard Deviation 0.00752
|
PRIMARY outcome
Timeframe: Cycle 3: 4 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
MMAE
|
1.4529 ng/mL
Standard Deviation 1.36620
|
1.7171 ng/mL
Standard Deviation 4.42914
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0397 ng/mL
Standard Deviation 0.01323
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0163 ng/mL
Standard Deviation 0.00804
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0118 ng/mL
Standard Deviation 0.00600
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
C8
|
0.0190 ng/mL
Standard Deviation 0.01265
|
0.0446 ng/mL
Standard Deviation 0.05011
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0191 ng/mL
Standard Deviation 0.00637
|
PRIMARY outcome
Timeframe: Cycle 1: 24 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
MMAE
|
3.1227 ng/mL
Standard Deviation 2.38909
|
3.7950 ng/mL
Standard Deviation 4.12446
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
C4
|
0.0191 ng/mL
Standard Deviation 0.00637
|
0.0443 ng/mL
Standard Deviation 0.05328
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0218 ng/mL
Standard Deviation 0.02814
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0206 ng/mL
Standard Deviation 0.01477
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
C8
|
0.0196 ng/mL
Standard Deviation 0.01702
|
0.0805 ng/mL
Standard Deviation 0.06986
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
C13
|
0.0113 ng/mL
Standard Deviation 0.00377
|
0.0142 ng/mL
Standard Deviation 0.00660
|
PRIMARY outcome
Timeframe: Cycle 3: 24 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
C8
|
0.0177 ng/mL
Standard Deviation 0.01284
|
0.0715 ng/mL
Standard Deviation 0.04523
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
MMAE
|
2.2558 ng/mL
Standard Deviation 1.60345
|
3.2336 ng/mL
Standard Deviation 2.26369
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0200 ng/mL
Standard Deviation 0.01071
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0203 ng/mL
Standard Deviation 0.01109
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0164 ng/mL
Standard Deviation 0.00868
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0105 ng/mL
Standard Deviation 0.00371
|
PRIMARY outcome
Timeframe: Cycle 1: 48 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
MMAE
|
3.3727 ng/mL
Standard Deviation 2.61792
|
4.2140 ng/mL
Standard Deviation 3.69470
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
C4
|
0.0128 ng/mL
Standard Deviation 0.00565
|
0.0424 ng/mL
Standard Deviation 0.05259
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0168 ng/mL
Standard Deviation 0.02553
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0187 ng/mL
Standard Deviation 0.01608
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
C8
|
0.0210 ng/mL
Standard Deviation 0.01455
|
0.0959 ng/mL
Standard Deviation 0.06780
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0134 ng/mL
Standard Deviation 0.00763
|
PRIMARY outcome
Timeframe: Cycle 3: 48 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
MMAE
|
2.2156 ng/mL
Standard Deviation 1.70890
|
3.4733 ng/mL
Standard Deviation 2.17792
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0193 ng/mL
Standard Deviation 0.01407
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0198 ng/mL
Standard Deviation 0.01316
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0170 ng/mL
Standard Deviation 0.01112
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
C8
|
0.0195 ng/mL
Standard Deviation 0.01114
|
0.0746 ng/mL
Standard Deviation 0.06162
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0124 ng/mL
Standard Deviation 0.00438
|
PRIMARY outcome
Timeframe: Cycle 1: 72 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
MMAE
|
3.0948 ng/mL
Standard Deviation 2.03516
|
3.8931 ng/mL
Standard Deviation 3.61834
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
C4
|
0.0127 ng/mL
Standard Deviation 0.00423
|
0.0501 ng/mL
Standard Deviation 0.06242
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0190 ng/mL
Standard Deviation 0.02664
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0241 ng/mL
Standard Deviation 0.01640
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
C8
|
0.0187 ng/mL
Standard Deviation 0.01111
|
0.0899 ng/mL
Standard Deviation 0.06688
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0133 ng/mL
Standard Deviation 0.00644
|
PRIMARY outcome
Timeframe: Cycle 3: 72 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
MMAE
|
1.9732 ng/mL
Standard Deviation 1.32391
|
3.3047 ng/mL
Standard Deviation 2.14127
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0310 ng/mL
Standard Deviation 0.01563
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0256 ng/mL
Standard Deviation 0.01510
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0168 ng/mL
Standard Deviation 0.01126
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
C8
|
0.0187 ng/mL
Standard Deviation 0.01079
|
0.0728 ng/mL
Standard Deviation 0.04348
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: 96 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
MMAE
|
3.2956 ng/mL
Standard Deviation 2.97022
|
2.9148 ng/mL
Standard Deviation 1.70500
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
C4
|
0.1420 ng/mL
Standard Deviation 0.04733
|
0.0136 ng/mL
Standard Deviation 0.00481
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
C5
|
0.0593 ng/mL
Standard Deviation 0.01977
|
0.0120 ng/mL
Standard Deviation 0.00643
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
C7
|
0.0374 ng/mL
Standard Deviation 0.01247
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
C8
|
0.0228 ng/mL
Standard Deviation 0.06198
|
0.0660 ng/mL
Standard Deviation 0.04349
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
C13
|
0.0108 ng/mL
Standard Deviation 0.00360
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 96 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
MMAE
|
2.2344 ng/mL
Standard Deviation 1.81211
|
2.4449 ng/mL
Standard Deviation 1.44334
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
C4
|
0.0418 ng/mL
Standard Deviation 0.01393
|
0.0140 ng/mL
Standard Deviation 0.00704
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
C5
|
0.0294 ng/mL
Standard Deviation 0.00980
|
0.0205 ng/mL
Standard Deviation 0.01017
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
C7
|
0.0252 ng/mL
Standard Deviation 0.00840
|
0.0121 ng/mL
Standard Deviation 0.00428
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
C8
|
0.0392 ng/mL
Standard Deviation 0.04163
|
0.0622 ng/mL
Standard Deviation 0.04328
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0105 ng/mL
Standard Deviation 0.00371
|
PRIMARY outcome
Timeframe: Cycle 1: 144 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
MMAE
|
1.7990 ng/mL
Standard Deviation 0.89695
|
2.3326 ng/mL
Standard Deviation 1.45619
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0297 ng/mL
Standard Deviation 0.02569
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0174 ng/mL
Standard Deviation 0.01006
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0196 ng/mL
Standard Deviation 0.00693
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
C8
|
0.0120 ng/mL
Standard Deviation 0.00542
|
0.0497 ng/mL
Standard Deviation 0.02722
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 144 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
MMAE
|
1.2920 ng/mL
Standard Deviation 0.75690
|
2.0555 ng/mL
Standard Deviation 1.07315
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0198 ng/mL
Standard Deviation 0.00976
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0140 ng/mL
Standard Deviation 0.00760
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0137 ng/mL
Standard Deviation 0.00484
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
C8
|
0.0145 ng/mL
Standard Deviation 0.00648
|
0.0441 ng/mL
Standard Deviation 0.02147
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: 336 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
MMAE
|
0.2723 ng/mL
Standard Deviation 0.16544
|
0.3130 ng/mL
Standard Deviation 0.15743
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0127 ng/mL
Standard Deviation 0.00672
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 336 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
MMAE
|
0.2578 ng/mL
Standard Deviation 0.10847
|
0.4258 ng/mL
Standard Deviation 0.30565
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0168 ng/mL
Standard Deviation 0.01011
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 480 hour postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
MMAE
|
0.0941 ng/mL
Standard Deviation 0.03974
|
0.1189 ng/mL
Standard Deviation 0.15808
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
C4
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
C5
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
C7
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
C8
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0114 ng/mL
Standard Deviation 0.00431
|
|
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
C13
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: PredosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
MMAE
|
7.8900 ng
Standard Deviation 2.63000
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
C8
|
0.0712 ng
Standard Deviation 0.02373
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: 0-24 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
MMAE
|
12.5020 ng
Standard Deviation 6.85958
|
12.5668 ng
Standard Deviation 5.31374
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
C4
|
0.0521 ng
Standard Deviation 0.02335
|
0.0878 ng
Standard Deviation 0.13223
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
C5
|
0.0254 ng
Standard Deviation 0.00847
|
0.0883 ng
Standard Deviation 0.10135
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
C8
|
0.1047 ng
Standard Deviation 0.07785
|
0.5967 ng
Standard Deviation 0.56221
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
C13
|
0.0456 ng
Standard Deviation 0.03714
|
0.0786 ng
Standard Deviation 0.11460
|
PRIMARY outcome
Timeframe: Cycle 1: 24-48 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
MMAE
|
11.7995 ng
Standard Deviation 6.20286
|
12.6225 ng
Standard Deviation 6.93735
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
C4
|
0.0392 ng
Standard Deviation 0.03010
|
0.0690 ng
Standard Deviation 0.10935
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
C5
|
0.0277 ng
Standard Deviation 0.01700
|
0.0863 ng
Standard Deviation 0.09138
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
C8
|
0.1568 ng
Standard Deviation 0.08381
|
0.7275 ng
Standard Deviation 0.59716
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
C13
|
0.0405 ng
Standard Deviation 0.03473
|
0.0722 ng
Standard Deviation 0.07482
|
PRIMARY outcome
Timeframe: Cycle 1: 48-72 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
MMAE
|
11.6600 ng
Standard Deviation 5.45329
|
12.4089 ng
Standard Deviation 4.49922
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
C4
|
0.0419 ng
Standard Deviation 0.02694
|
0.0812 ng
Standard Deviation 0.15006
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
C5
|
0.0322 ng
Standard Deviation 0.01859
|
0.0867 ng
Standard Deviation 0.10841
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
C8
|
0.1189 ng
Standard Deviation 0.08494
|
0.7973 ng
Standard Deviation 0.38226
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
C13
|
0.0382 ng
Standard Deviation 0.02718
|
0.0786 ng
Standard Deviation 0.05672
|
PRIMARY outcome
Timeframe: Cycle 1: 72-96 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
MMAE
|
12.8426 ng
Standard Deviation 5.93538
|
10.7766 ng
Standard Deviation 8.14858
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
C4
|
0.0427 ng
Standard Deviation 0.02848
|
0.0867 ng
Standard Deviation 0.16449
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
C5
|
0.0394 ng
Standard Deviation 0.02131
|
0.0882 ng
Standard Deviation 0.11202
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
C8
|
0.1247 ng
Standard Deviation 0.08379
|
0.7480 ng
Standard Deviation 0.61219
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
C13
|
0.0415 ng
Standard Deviation 0.02723
|
0.0754 ng
Standard Deviation 0.06820
|
PRIMARY outcome
Timeframe: Cycle 1: 96-120 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
MMAE
|
9.5626 ng
Standard Deviation 7.26020
|
10.8018 ng
Standard Deviation 12.03431
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
C4
|
0.0414 ng
Standard Deviation 0.03529
|
0.0885 ng
Standard Deviation 0.11811
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
C5
|
0.0406 ng
Standard Deviation 0.02753
|
0.1053 ng
Standard Deviation 0.10639
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
C8
|
0.1034 ng
Standard Deviation 0.10563
|
0.7360 ng
Standard Deviation 1.02417
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
C13
|
0.0380 ng
Standard Deviation 0.03436
|
0.0630 ng
Standard Deviation 0.08155
|
PRIMARY outcome
Timeframe: Cycle 1: 120-144 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
MMAE
|
7.9830 ng
Standard Deviation 4.33309
|
6.7161 ng
Standard Deviation 6.13997
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
C4
|
0.0335 ng
Standard Deviation 0.02037
|
0.0730 ng
Standard Deviation 0.08387
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
C5
|
0.0301 ng
Standard Deviation 0.01767
|
0.0836 ng
Standard Deviation 0.07377
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
C8
|
0.0910 ng
Standard Deviation 0.06044
|
0.4477 ng
Standard Deviation 0.56047
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
C13
|
0.0345 ng
Standard Deviation 0.01738
|
0.0551 ng
Standard Deviation 0.05107
|
PRIMARY outcome
Timeframe: Cycle 1: 144-168 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
MMAE
|
5.8025 ng
Standard Deviation 3.45889
|
5.5693 ng
Standard Deviation 3.50945
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
C4
|
0.0448 ng
Standard Deviation 0.02158
|
0.0579 ng
Standard Deviation 0.06807
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
C5
|
0.0287 ng
Standard Deviation 0.01527
|
0.0747 ng
Standard Deviation 0.05078
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
C8
|
0.0706 ng
Standard Deviation 0.03027
|
0.3916 ng
Standard Deviation 0.34491
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
C13
|
0.0363 ng
Standard Deviation 0.01283
|
0.0438 ng
Standard Deviation 0.03146
|
PRIMARY outcome
Timeframe: Cycle 1: 336-360 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
MMAE
|
1.3326 ng
Standard Deviation 0.80959
|
1.0727 ng
Standard Deviation 0.55233
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0459 ng
Standard Deviation 0.01530
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0289 ng
Standard Deviation 0.00963
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
C8
|
0.0401 ng
Standard Deviation 0.02242
|
0.0751 ng
Standard Deviation 0.04505
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 1: 480-504 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
MMAE
|
0.3505 ng
Standard Deviation 0.14592
|
0.4420 ng
Standard Deviation 0.30745
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
C8
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0578 ng
Standard Deviation 0.03314
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: PredosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
MMAE
|
0.4227 ng
Standard Deviation 0.17918
|
0.3171 ng
Standard Deviation 0.33548
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
C8
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0392 ng
Standard Deviation 0.02985
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
PRIMARY outcome
Timeframe: Cycle 3: 0-24 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
C8
|
0.1285 ng
Standard Deviation 0.17930
|
0.4657 ng
Standard Deviation 0.41352
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
MMAE
|
12.4438 ng
Standard Deviation 8.86144
|
10.7174 ng
Standard Deviation 15.35912
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
C4
|
0.0451 ng
Standard Deviation 0.02977
|
0.0454 ng
Standard Deviation 0.07644
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
C5
|
0.0301 ng
Standard Deviation 0.01847
|
0.0509 ng
Standard Deviation 0.04623
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
C13
|
0.0676 ng
Standard Deviation 0.05022
|
0.0516 ng
Standard Deviation 0.07045
|
PRIMARY outcome
Timeframe: Cycle 3: 24-48 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
MMAE
|
13.2483 ng
Standard Deviation 4.79482
|
11.1360 ng
Standard Deviation 6.73693
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
C4
|
0.0413 ng
Standard Deviation 0.03095
|
0.0604 ng
Standard Deviation 0.05049
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
C5
|
0.0311 ng
Standard Deviation 0.02021
|
0.0808 ng
Standard Deviation 0.06838
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
C8
|
0.1600 ng
Standard Deviation 0.11946
|
0.5750 ng
Standard Deviation 0.58196
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
C13
|
0.0507 ng
Standard Deviation 0.03607
|
0.0637 ng
Standard Deviation 0.05102
|
PRIMARY outcome
Timeframe: Cycle 3: 48-72 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
MMAE
|
13.8072 ng
Standard Deviation 8.63973
|
12.7267 ng
Standard Deviation 8.96991
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
C4
|
0.0524 ng
Standard Deviation 0.04691
|
0.0620 ng
Standard Deviation 0.06222
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
C5
|
0.0406 ng
Standard Deviation 0.03034
|
0.0746 ng
Standard Deviation 0.09237
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
C8
|
0.1598 ng
Standard Deviation 0.14846
|
0.6950 ng
Standard Deviation 0.83588
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
C13
|
0.0746 ng
Standard Deviation 0.05134
|
0.0632 ng
Standard Deviation 0.06480
|
PRIMARY outcome
Timeframe: Cycle 3: 72-96 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
MMAE
|
12.2263 ng
Standard Deviation 6.09003
|
11.2527 ng
Standard Deviation 8.65574
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
C4
|
0.0611 ng
Standard Deviation 0.05055
|
0.0702 ng
Standard Deviation 0.07079
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
C5
|
0.0437 ng
Standard Deviation 0.03084
|
0.0937 ng
Standard Deviation 0.10757
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
C8
|
0.1510 ng
Standard Deviation 0.11532
|
0.5276 ng
Standard Deviation 0.95507
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
C13
|
0.0564 ng
Standard Deviation 0.03759
|
0.0573 ng
Standard Deviation 0.07734
|
PRIMARY outcome
Timeframe: Cycle 3: 96-120 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
MMAE
|
8.1426 ng
Standard Deviation 7.29530
|
8.3817 ng
Standard Deviation 7.78279
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
C4
|
0.0512 ng
Standard Deviation 0.04137
|
0.0710 ng
Standard Deviation 0.05912
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
C5
|
0.0435 ng
Standard Deviation 0.02885
|
0.0916 ng
Standard Deviation 0.08893
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
C8
|
0.1088 ng
Standard Deviation 0.09569
|
0.5198 ng
Standard Deviation 0.79634
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
C13
|
0.0524 ng
Standard Deviation 0.03619
|
0.0607 ng
Standard Deviation 0.06838
|
PRIMARY outcome
Timeframe: Cycle 3: 120-144 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
MMAE
|
7.5871 ng
Standard Deviation 4.66863
|
7.3500 ng
Standard Deviation 3.78427
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
C4
|
0.0520 ng
Standard Deviation 0.03870
|
0.0461 ng
Standard Deviation 0.03666
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
C5
|
0.0342 ng
Standard Deviation 0.02508
|
0.0657 ng
Standard Deviation 0.04811
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
C8
|
0.0869 ng
Standard Deviation 0.07672
|
0.4700 ng
Standard Deviation 0.37131
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
C13
|
0.0429 ng
Standard Deviation 0.02820
|
0.0386 ng
Standard Deviation 0.03212
|
PRIMARY outcome
Timeframe: Cycle 3: 144-168 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
MMAE
|
4.6823 ng
Standard Deviation 2.80767
|
6.1125 ng
Standard Deviation 3.83207
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
C4
|
0.0562 ng
Standard Deviation 0.02674
|
0.0538 ng
Standard Deviation 0.04252
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
C5
|
0.0308 ng
Standard Deviation 0.01718
|
0.0662 ng
Standard Deviation 0.06110
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
C8
|
0.0651 ng
Standard Deviation 0.03984
|
0.3485 ng
Standard Deviation 0.45898
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
C13
|
0.0481 ng
Standard Deviation 0.01603
|
0.0402 ng
Standard Deviation 0.04117
|
PRIMARY outcome
Timeframe: Cycle 3: 336-360 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
MMAE
|
0.8271 ng
Standard Deviation 0.43597
|
1.2811 ng
Standard Deviation 1.55068
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0377 ng
Standard Deviation 0.01812
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0347 ng
Standard Deviation 0.02457
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
C8
|
0.0277 ng
Standard Deviation 0.01306
|
0.0734 ng
Standard Deviation 0.10958
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0227 ng
Standard Deviation 0.00757
|
PRIMARY outcome
Timeframe: Cycle 3: 480-504 hours postdosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
MMAE
|
0.3334 ng
Standard Deviation 0.25074
|
0.4660 ng
Standard Deviation 0.41713
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
C4
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0248 ng
Standard Deviation 0.00827
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
C5
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
0.0377 ng
Standard Deviation 0.01257
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
C7
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
C8
|
0.0221 ng
Standard Deviation 0.00737
|
0.0620 ng
Standard Deviation 0.04967
|
|
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
C13
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
SECONDARY outcome
Timeframe: Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
The LLQ for all the observations was 12.5 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 1, 72 hour
|
5958.0569 ng/mL
Standard Deviation 1788.56378
|
4265.7542 ng/mL
Standard Deviation 2880.39660
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 1, Predose
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 1, 0.5 hour
|
33125.0025 ng/mL
Standard Deviation 10398.79403
|
29609.7759 ng/mL
Standard Deviation 11865.35702
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 1, 4 hour
|
24533.2372 ng/mL
Standard Deviation 6767.70744
|
24398.6482 ng/mL
Standard Deviation 8092.41448
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 1, 336 hour
|
1108.6515 ng/mL
Standard Deviation 376.81123
|
1167.0713 ng/mL
Standard Deviation 740.05650
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 2, Predose
|
435.1550 ng/mL
Standard Deviation 303.25245
|
794.3851 ng/mL
Standard Deviation 10732.46886
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 2, 0.5 hour
|
31627.2566 ng/mL
Standard Deviation 6716.71906
|
16032.6494 ng/mL
Standard Deviation 15714.59821
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, Predose
|
536.3692 ng/mL
Standard Deviation 524.72923
|
611.0573 ng/mL
Standard Deviation 786.52082
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, 0.5 hour
|
33040.2245 ng/mL
Standard Deviation 6295.45517
|
20991.9618 ng/mL
Standard Deviation 12662.05087
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, 4 hour
|
24496.7203 ng/mL
Standard Deviation 4212.84997
|
15378.8274 ng/mL
Standard Deviation 9550.99903
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, 72 hour
|
4262.0364 ng/mL
Standard Deviation 2431.24647
|
3258.7237 ng/mL
Standard Deviation 3358.78504
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, 336 hour
|
1363.9488 ng/mL
Standard Deviation 789.04877
|
1381.2290 ng/mL
Standard Deviation 1224.66857
|
|
Serum Concentrations of Antibody-drug Conjugate (ADC)
Cycle 3, 480 hour
|
734.5557 ng/mL
Standard Deviation 634.23889
|
648.2492 ng/mL
Standard Deviation 1065.26404
|
SECONDARY outcome
Timeframe: Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dosePopulation: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
The LLQ for all the observations was 12.5 ng/mL.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=9 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Serum Concentration of Total Antibody (TAb)
Cycle 1, Predose
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
NA ng/mL
Standard Deviation NA
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 1, 0.5 hour
|
30884.9074 ng/mL
Standard Deviation 9956.67036
|
30874.4957 ng/mL
Standard Deviation 11904.18494
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 1, 4 hour
|
28865.4674 ng/mL
Standard Deviation 8192.50406
|
28577.3869 ng/mL
Standard Deviation 9365.88746
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 1, 72 hour
|
11626.2147 ng/mL
Standard Deviation 4396.55604
|
9931.2943 ng/mL
Standard Deviation 4973.74692
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 1, 336 hour
|
3066.5859 ng/mL
Standard Deviation 1017.84204
|
2898.2924 ng/mL
Standard Deviation 1831.73997
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 2, Predose
|
1363.8319 ng/mL
Standard Deviation 904.27346
|
2055.3871 ng/mL
Standard Deviation 10312.91280
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 2, 0.5 hour
|
31583.7793 ng/mL
Standard Deviation 7742.69918
|
17378.2105 ng/mL
Standard Deviation 17543.51968
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, Predose
|
1517.6506 ng/mL
Standard Deviation 1200.68646
|
1361.3147 ng/mL
Standard Deviation 1592.89993
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, 0.5 hour
|
33892.4731 ng/mL
Standard Deviation 10595.70675
|
15974.3723 ng/mL
Standard Deviation 12467.10368
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, 4 hour
|
27548.1773 ng/mL
Standard Deviation 7219.71925
|
11609.1430 ng/mL
Standard Deviation 14719.69968
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, 72 hour
|
9588.9374 ng/mL
Standard Deviation 5665.38218
|
13594.2016 ng/mL
Standard Deviation 7492.70742
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, 336 hour
|
3628.9175 ng/mL
Standard Deviation 1802.66091
|
3206.6925 ng/mL
Standard Deviation 3000.22116
|
|
Serum Concentration of Total Antibody (TAb)
Cycle 3, 480 hour
|
1866.5746 ng/mL
Standard Deviation 1326.12113
|
1329.0886 ng/mL
Standard Deviation 2024.17213
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs
|
9 participants
|
9 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and 3Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Negative in both Cycle 1 and 3
|
7 participants
|
5 participants
|
|
Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Positive in both Cycle 1 and 3
|
0 participants
|
1 participants
|
|
Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Transient Positive
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Laboratory Values
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Vital signs included body temperature, body weight, blood pressure and heart rate.
Outcome measures
| Measure |
Brentuximab Vedotin + Rifampicin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
Brentuximab Vedotin
n=10 Participants
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
|
2 participants
|
1 participants
|
Adverse Events
Brentuximab Vedotin
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Brentuximab Vedotin + Rifampicin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brentuximab Vedotin
n=10 participants at risk
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
Brentuximab Vedotin + Rifampicin
n=10 participants at risk
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
|---|---|---|
|
General disorders
Thrombosis in device
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Staphylococcal infection
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Pulmonary tuberculosis
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Nervous system disorders
Neuralgia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
Other adverse events
| Measure |
Brentuximab Vedotin
n=10 participants at risk
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
|
Brentuximab Vedotin + Rifampicin
n=10 participants at risk
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
30.0%
3/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Investigations
Body temperature increased
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Chills
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Eye disorders
Glaucoma
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Local swelling
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Localised oedema
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Injury, poisoning and procedural complications
Scratch
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Infections and infestations
Viral infection
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Investigations
Weight increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER