Trial Outcomes & Findings for Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL) (NCT NCT01925612)
NCT ID: NCT01925612
Last Updated: 2018-06-21
Results Overview
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2018-06-21
Participant Flow
Two patients enrolled but did not receive treatment.
Participant milestones
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
22
|
11
|
11
|
12
|
|
Overall Study
COMPLETED
|
25
|
18
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
3
|
0
|
1
|
2
|
Baseline Characteristics
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
64 years
n=7 Participants
|
59 years
n=5 Participants
|
68 years
n=4 Participants
|
65 years
n=21 Participants
|
66 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
22 participants
n=7 Participants
|
11 participants
n=5 Participants
|
8 participants
n=4 Participants
|
10 participants
n=21 Participants
|
82 participants
n=10 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Complete Remission Rate
|
20 Participants
|
16 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber (count) of participants that experienced at least 1 adverse event.
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
29 Participants
|
22 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Incidence of Laboratory Abnormalities
Any Hematology Test
|
10 Participants
|
16 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities
Lymphocytes (x10^3/uL)
|
8 Participants
|
15 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities
Absolute Neutrophil Count (x10^3/uL)
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Neutrophils (x10^3/uL)
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Leukocytes (x10^3/uL)
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Hemoglobin (x10^3/uL)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Platelets (x10^3/uL)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Any Chemistry Test
|
4 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities
Glucose (mg/dL)
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities
Potassium (mEq)/L
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Laboratory Abnormalities
Calcium (mg/dL)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Sodium (mEq/L)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities
Alanine Aminotransferase (IU/L)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsNumber (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Objective Response Rate
|
23 Participants
|
19 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsMedian progression-free survival (in months) and observed minimum-maximum range.
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
NA Months
Interval 0.62 to 40.21
Insufficient number of participants with events to determine median (\<50%)
|
NA Months
Interval 1.28 to 39.85
Insufficient number of participants with events to determine median (\<50%)
|
NA Months
Interval 3.35 to 24.34
Insufficient number of participants with events to determine median (\<50%)
|
NA Months
Interval 3.25 to 15.41
Insufficient number of participants with events to determine median (\<50%)
|
NA Months
Interval 1.25 to 16.43
Insufficient number of participants with events to determine median (\<50%)
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsMedian overall survival (in months) and observed minimum-maximum range.
Outcome measures
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 Participants
Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 Participants
Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone).
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 Participants
Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy.
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 Participants
Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone.
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Overall Survival
|
NA Months
Interval 0.62 to 42.79
Insufficient number of participants with events to estimate median (\<50%)
|
NA Months
Interval 1.28 to 44.29
Insufficient number of participants with events to estimate median (\<50%)
|
NA Months
Interval 16.56 to 25.76
Insufficient number of participants with events to estimate median (\<50%)
|
NA Months
Interval 3.25 to 16.85
Insufficient number of participants with events to estimate median (\<50%)
|
NA Months
Interval 1.25 to 19.22
Insufficient number of participants with events to estimate median (\<50%)
|
Adverse Events
Part 1: BV(1.2 mg/kg) + RCHOP
Serious events: 16 serious events
Other events: 29 other events
Deaths: 1 deaths
Part 1: BV(1.8 mg/kg) + RCHOP
Serious events: 14 serious events
Other events: 22 other events
Deaths: 2 deaths
Part 2: BV(1.8 mg/kg) + RCHP
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 3: BV(1.8 mg/kg) + RCHP
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Part 3: RCHOP
Serious events: 4 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 participants at risk
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 participants at risk
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
27.6%
8/29 • Number of events 13 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
8/22 • Number of events 13 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Bacteraemia
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Escherichia infection
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Pantoea agglomerans infection
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Ileus
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Intestinal perforation
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Asthenia
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Chest pain
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Cardiomyopathy
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Cytomegalovirus test positive
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
White blood cell count decreased
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Guillain-barre syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Eye disorders
Visual impairment
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Hypovolaemic shock
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
Other adverse events
| Measure |
Part 1: BV(1.2 mg/kg) + RCHOP
n=29 participants at risk
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 1: BV(1.8 mg/kg) + RCHOP
n=22 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 2: BV(1.8 mg/kg) + RCHP
n=11 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: BV(1.8 mg/kg) + RCHP
n=11 participants at risk
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
Part 3: RCHOP
n=12 participants at risk
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Nausea
|
48.3%
14/29 • Number of events 24 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
68.2%
15/22 • Number of events 23 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
72.7%
8/11 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
4/11 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.3%
14/29 • Number of events 19 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
68.2%
15/22 • Number of events 23 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
54.5%
6/11 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
40.9%
9/22 • Number of events 12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
54.5%
6/11 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
41.7%
5/12 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
7/29 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
63.6%
14/22 • Number of events 17 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Stomatitis
|
27.6%
8/29 • Number of events 10 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.7%
6/29 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Gastrointestinal disorders
Toothache
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.2%
5/29 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
40.9%
9/22 • Number of events 10 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
72.7%
8/11 • Number of events 10 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
25.0%
3/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Fatigue
|
58.6%
17/29 • Number of events 28 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
72.7%
16/22 • Number of events 30 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
63.6%
7/11 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
25.0%
3/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Asthenia
|
27.6%
8/29 • Number of events 19 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
31.8%
7/22 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Chills
|
24.1%
7/29 • Number of events 12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Oedema peripheral
|
24.1%
7/29 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
31.8%
7/22 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Pyrexia
|
20.7%
6/29 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
6/22 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Mucosal inflammation
|
6.9%
2/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Influenza like illness
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Peripheral swelling
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Pain
|
6.9%
2/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
General disorders
Malaise
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
55.2%
16/29 • Number of events 25 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
68.2%
15/22 • Number of events 27 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
54.5%
6/11 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
4/11 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
33.3%
4/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Headache
|
20.7%
6/29 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
6/22 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
8/22 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
25.0%
3/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.8%
4/29 • Number of events 11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
8/22 • Number of events 14 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Dysgeusia
|
13.8%
4/29 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
22.7%
5/22 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Restless legs syndrome
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Hypoaesthesia
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Nervous system disorders
Paraesthesia
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
4/11 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.1%
7/29 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
40.9%
9/22 • Number of events 12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
33.3%
4/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract irritation
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.9%
2/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.1%
7/29 • Number of events 10 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
45.5%
10/22 • Number of events 15 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
25.0%
3/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
40.9%
9/22 • Number of events 11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.7%
6/29 • Number of events 10 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
22.7%
5/22 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
22.7%
5/22 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Ear and labyrinth disorders
Hyponatraemia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.5%
10/29 • Number of events 27 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
31.8%
7/22 • Number of events 20 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
4/11 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
4/11 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
9/29 • Number of events 26 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
31.8%
7/22 • Number of events 20 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
3/11 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.2%
5/29 • Number of events 20 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 19 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
2/29 • Number of events 13 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 16 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
5/29 • Number of events 6 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
16.7%
2/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.7%
6/29 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.4%
1/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Candida infection
|
17.2%
5/29 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
22.7%
5/22 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Oral candidiasis
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Oral herpes
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Psychiatric disorders
Insomnia
|
24.1%
7/29 • Number of events 7 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
8/22 • Number of events 8 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Psychiatric disorders
Confusional state
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Psychiatric disorders
Depression
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Weight decreased
|
34.5%
10/29 • Number of events 16 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
36.4%
8/22 • Number of events 13 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
25.0%
3/12 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
Neutrophil count decreased
|
3.4%
1/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
27.3%
6/22 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Hot flush
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Hypertension
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Tachycardia
|
27.6%
8/29 • Number of events 9 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
4/22 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Vascular disorders
Palpitations
|
6.9%
2/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
18.2%
2/11 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Injury, poisoning and procedural complications
Laceration
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Renal and urinary disorders
Pollakiuria
|
10.3%
3/29 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
4.5%
1/22 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Eye disorders
Lacrimation increased
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
13.6%
3/22 • Number of events 4 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Ear and labyrinth disorders
Ear pain
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
2/22 • Number of events 2 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/29 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/22 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
9.1%
1/11 • Number of events 1 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/11 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
0.00%
0/12 • Adverse events were reported from study Day 1 (predose) though the EOT visit or 30 days after the last study treatment (Brentuximab vedotin or combination treatment), whichever was later. However, all protocol-related AEs were collected from the time of informed consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60