Trial Outcomes & Findings for Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) (NCT NCT01657331)
NCT ID: NCT01657331
Last Updated: 2026-06-24
Results Overview
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
21 days
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2
Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle).
Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
7
|
11
|
37
|
|
Overall Study
COMPLETED
|
5
|
3
|
5
|
9
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2
Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle).
Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)
Baseline characteristics by cohort
| Measure |
Phase 1: Brentuximab Vedotin1.2 mg/kg, Bendamustine 70mg/m^2
n=7 Participants
Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
n=3 Participants
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
n=7 Participants
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=11 Participants
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2
n=37 Participants
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle).
Doses were administered by IV infusions over 30 minutes.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 8.8 • n=20 Participants
|
44 years
STANDARD_DEVIATION 10.4 • n=20 Participants
|
37.3 years
STANDARD_DEVIATION 8.6 • n=40 Participants
|
39.1 years
STANDARD_DEVIATION 13.4 • n=6 Participants
|
34.9 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 11.3 • n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
34 Participants
n=7 Participants
|
50 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here.
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
|
1.8 mg/kg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: This Outcome Measure is specific to Phase 1 of the study, so only Phase 1 population is reported here.
This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
|
90 mg/m2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 daysDLT is defined as any missed dose within cycle 1 or toxicity that was possibly related to the study drug occurring up to 7 days after completion of cycle 1 that resulted in a delay of initiation of cycle 2; grade 4 neutropenia that did not resolve to grade 2 or lower within 7 days; grade 4 thrombocytopenia lasting more than 7 days; grade 3 febrile neutropenia (absolute neutrophil count of \<1000 cells per μL with a single temperature of \>38·3°C or a sustained temperature of ≥38°C for \>1 h); and any grade 3 or worse non-haematological toxicity, with the specific exception of nausea, vomiting, diarrhoea, or dehydration lasting for more than 48 h in the setting of inadequate compliance with supportive care measures or grade 3 hypercholesterolaemia, hypertriglyceridaemia, constipation, or fatigue.
Outcome measures
| Measure |
Phase 1
n=7 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
n=3 Participants
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
n=7 Participants
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=11 Participants
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 3 yearsThe number of subjects whose cancer shrinks or disappears after study treatment
Outcome measures
| Measure |
Phase 1
n=6 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
n=3 Participants
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
n=7 Participants
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=8 Participants
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=25 Participants
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 50 monthsPopulation: Pre-specified to report all Phase 1 data as a single Arm
Duration of response is defined as the time from documentation of a response to treatment to the first documentation of tumor progression, or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Duration of Response (DoR) in Phase 1
|
4.3 months
Interval 0.0 to 7.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 50 monthsPopulation: Pre-specified to report all Phase 1 data as a single Arm
The length of time during and after the study treatment that a subject lives with the disease but it does not get worse.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in Phase 1
|
7.5 months
Interval 4.8 to 12.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 50 monthsPopulation: Pre-specified to report all Phase 1 data as a single Arm
The length of time from either the date of diagnosis or the start of study treatment that subjects diagnosed with the disease are still alive.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Phase 1 includes 28 total participants from Cohorts 1, 2, 3, and 4. Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma received Brentuximab Vedotin in combination with Bendamustine.
Brentuximab Vedotin: Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
Bendamustine: Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Overall Survival (OS) in Phase 1
|
43.3 months
Interval 11.0 to
The upper limit of the 95% confidence interval was not reached due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Investigator has left the institution. No data was available or analyzed.
This is designed to measure the response to study treatment if the level declines.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Investigator has left the institution. No data was available or analyzed.
The level will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Investigator has left the institution. No data was available or analyzed.
The decline will be evaluated as a function of response to therapy with brentuximab vedotin and bendamustine.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Serious events: 5 serious events
Other events: 11 other events
Deaths: 6 deaths
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
Serious events: 12 serious events
Other events: 35 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2
n=7 participants at risk
Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
n=3 participants at risk
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
n=7 participants at risk
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=11 participants at risk
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=37 participants at risk
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Skin and subcutaneous tissue disorders
CMV Infection
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Dehydration
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Immune system disorders
Febrile neutropenia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Fever
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
myelosuppression
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
nausea grade 3
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
staphylococcal bacteremia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
vomiting grade 2
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
Other adverse events
| Measure |
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2
n=7 participants at risk
Cohort 1: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 70 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 80 mg/m^2
n=3 participants at risk
Cohort 2: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.2 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 80 mg/m^2
n=7 participants at risk
Cohort 3: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 80 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 1: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=11 participants at risk
Cohort 4: Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
Phase 2: Brentuximab Vedotin 1.8 mg/kg, Bendamustine 90 mg/m^2
n=37 participants at risk
Subjects with relapsed or refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma will receive 1.8 mg/kg of Brentuximab Vedotin (Day 1 of each 21-day cycle) in combination with 90 mg/m\^2 of Bendamustine (Day 1 and 2 of each 21-day cycle). Doses were administered by IV infusions over 30 minutes.
|
|---|---|---|---|---|---|
|
General disorders
Abdominal pain
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Immune system disorders
Alanine aminotransferase increased
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Alopecia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Anorexia
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
66.7%
2/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
36.4%
4/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
13.5%
5/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Anxiety
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
66.7%
2/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
36.4%
4/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Arthralgia
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Immune system disorders
Aspartate aminotransferase increased
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Back pain
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Chills
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
13.5%
5/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Confusion
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
45.5%
5/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
16.2%
6/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Cough
|
57.1%
4/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
36.4%
4/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
32.4%
12/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Dehydration
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
4/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
57.1%
4/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
37.8%
14/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Dizziness
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Dry mouth
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Dysgeusia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
66.7%
2/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
45.5%
5/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
24.3%
9/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Vascular disorders
Epistaxis
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
100.0%
3/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
85.7%
6/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
63.6%
7/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
67.6%
25/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Fever
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
43.2%
16/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Flushing
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Headache
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
21.6%
8/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Hot flashes
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Hyperglycemia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Hyperhidrosis
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Hyponatremia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Infusion related reaction
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.9%
7/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Insomnia
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Lymphedema
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Mucositis oral
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Nasal congestion
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
8.1%
3/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Nausea
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
66.7%
2/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
100.0%
7/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
90.9%
10/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
56.8%
21/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.0%
10/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Pain in extremity
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Paresthesia
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Pelvic pain
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
85.7%
6/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
10.8%
4/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Phlebitis
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
18.2%
2/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
5.4%
2/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Pruritus
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
42.9%
3/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
54.5%
6/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
16.2%
6/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Rash
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
27.3%
3/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
24.3%
9/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Infections and infestations
Skin infection
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Sore throat
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Stomach pain
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
9.1%
1/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Toothache
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
General disorders
Vomiting
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
33.3%
1/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
28.6%
2/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
36.4%
4/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
35.1%
13/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
|
Respiratory, thoracic and mediastinal disorders
tachycardia
|
0.00%
0/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/3 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
14.3%
1/7 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
0.00%
0/11 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
2.7%
1/37 • Non-serious AEs and SAEs were monitored at all routine visits and with each treatment, up to 4 months. Deaths were monitored at all routine visits and with each treatment, and during long-term follow-up of patients after treatment was completed, up to 50 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place