Trial Outcomes & Findings for A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NCT NCT01421667)
NCT ID: NCT01421667
Last Updated: 2016-11-28
Results Overview
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2016-11-28
Participant Flow
Aug 2011 - Jun 2015
Four additional patients enrolled, but withdrew prior to receiving treatment.
Participant milestones
| Measure |
CD30+ T-Cell NHL, BV
Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
|
CD30+ B-Cell NHL, BV
Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
|
CD30u DLBCL, BV
Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
|
CD30+ DLBCL, BV+R
Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
68
|
53
|
16
|
|
Overall Study
COMPLETED
|
35
|
66
|
51
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
CD30+ T-Cell NHL, BV
Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
|
CD30+ B-Cell NHL, BV
Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
|
CD30u DLBCL, BV
Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
|
CD30+ DLBCL, BV+R
Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
CD30+ T-Cell NHL, BV
n=35 Participants
|
CD30+ B-Cell NHL, BV
n=68 Participants
|
CD30u DLBCL, BV
n=53 Participants
|
CD30+ DLBCL, BV+R
n=16 Participants
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
57 years
n=7 Participants
|
65 years
n=5 Participants
|
62 years
n=4 Participants
|
63 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Pathological Diagnosis
Diffuse Large B-Cell Lymphoma (DLBCL)
|
0 participants
n=5 Participants
|
43 participants
n=7 Participants
|
53 participants
n=5 Participants
|
16 participants
n=4 Participants
|
112 participants
n=21 Participants
|
|
Pathological Diagnosis
Epstein-Barr Virus-Associated DLBCL of Elderly
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Pathological Diagnosis
Follicular Lymphoma
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Pathological Diagnosis
Gray Zone Lymphoma
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Pathological Diagnosis
Primary Mediastinal B-Cell Lymphoma
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Pathological Diagnosis
Post-Transplant Lymphoproliferative Disorder
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Pathological Diagnosis
Plasmablastic Lymphoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Pathological Diagnosis
T-Cell Rich B-Cell Lymphoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Pathological Diagnosis
Angioimmunoblastic T-cell Lymphoma
|
13 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Pathological Diagnosis
Peripheral T-Cell Lymphoma Not Otherwise Specified
|
22 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Transformed Disease from Prior Non-Hodgkin Lymphoma
Yes
|
1 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
5 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Transformed Disease from Prior Non-Hodgkin Lymphoma
No
|
34 participants
n=5 Participants
|
54 participants
n=7 Participants
|
42 participants
n=5 Participants
|
11 participants
n=4 Participants
|
141 participants
n=21 Participants
|
|
Disease Stage
Stage I
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Disease Stage
Stage II
|
2 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Disease Stage
Stage III
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
11 participants
n=5 Participants
|
6 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Disease Stage
Stage IV
|
14 participants
n=5 Participants
|
31 participants
n=7 Participants
|
33 participants
n=5 Participants
|
6 participants
n=4 Participants
|
84 participants
n=21 Participants
|
|
Disease Stage
Unknown
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Bulky Disease (≥5 cm on at least one baseline index lesion)
Yes
|
5 participants
n=5 Participants
|
27 participants
n=7 Participants
|
35 participants
n=5 Participants
|
4 participants
n=4 Participants
|
71 participants
n=21 Participants
|
|
Bulky Disease (≥5 cm on at least one baseline index lesion)
No
|
30 participants
n=5 Participants
|
41 participants
n=7 Participants
|
18 participants
n=5 Participants
|
12 participants
n=4 Participants
|
101 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
0
|
7 participants
n=5 Participants
|
25 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
1
|
23 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
7 participants
n=4 Participants
|
96 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
2
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
0 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
3-5
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
% CD30 Expression by Visual Immunohistochemistry (vIHC)
|
15 percentage
n=5 Participants
|
35 percentage
n=7 Participants
|
0 percentage
n=5 Participants
|
50 percentage
n=4 Participants
|
8 percentage
n=21 Participants
|
|
Refractory to Frontline Therapy
Yes
|
25 participants
n=5 Participants
|
51 participants
n=7 Participants
|
34 participants
n=5 Participants
|
10 participants
n=4 Participants
|
120 participants
n=21 Participants
|
|
Refractory to Frontline Therapy
No
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
6 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Refractory to Frontline Therapy
Missing/Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Disease Status Relative to Most Recent Prior Therapy
Refractory
|
22 participants
n=5 Participants
|
55 participants
n=7 Participants
|
37 participants
n=5 Participants
|
9 participants
n=4 Participants
|
123 participants
n=21 Participants
|
|
Disease Status Relative to Most Recent Prior Therapy
Relapsed
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
7 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Disease Status Relative to Most Recent Prior Therapy
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=34 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=19 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=48 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=52 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
|
41 percentage of participants
Interval 24.6 to 59.3
|
26 percentage of participants
Interval 9.1 to 51.2
|
44 percentage of participants
Interval 29.5 to 58.8
|
31 percentage of participants
Interval 18.7 to 45.1
|
—
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All participants who received treatment with brentuximab vedotin plus rituximab.
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=16 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Any TEAE
|
16 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
TEAE Related to Study Drug
|
15 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
TEAE With Severity Grade >/=3
|
9 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Discontinued Treatment Due to Adverse Event
|
2 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Serious Adverse Event
|
3 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Serious Adverse Event Related to Study Drug
|
3 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Deaths (Within 30 Days of Last Dose)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Chemistry Laboratory Abnormalities >/=Grade 3
|
1 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Hematology Laboratory Abnormalities >/=Grade 3
|
7 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.
Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=12 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab
|
50 percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.
Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=34 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=19 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=48 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=52 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
n=12 Participants
|
|---|---|---|---|---|---|
|
Complete Remission (CR) Rate by Investigator
|
24 percentage of participants
Interval 10.7 to 41.2
|
16 percentage of participants
Interval 3.4 to 39.6
|
19 percentage of participants
Interval 8.9 to 32.6
|
12 percentage of participants
Interval 4.4 to 23.4
|
17 percentage of participants
Interval 2.1 to 48.4
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.
Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=14 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=5 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=21 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=16 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
|
7.6 months
Interval 1.3 to 36.1
|
1.6 months
Interval 1.4 to 34.0
|
4.7 months
Interval 0.0 to 22.7
|
4.7 months
Interval 0.5 to 11.6
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy and achieved CR
Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=8 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=3 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=9 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=6 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
|
NA months
Interval 1.8 to
Not reached because too few events
|
7.2 months
Interval 1.6 to 34.0
|
NA months
Interval 2.2 to
Not reached because too few events
|
11.6 months
Interval 1.4 to 11.6
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=34 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=19 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=48 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=52 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
|
2.5 months
Interval 0.3 to 37.4
|
2.9 months
Interval 0.6 to 36.3
|
4.0 months
Interval 0.6 to 24.0
|
1.4 months
Interval 0.4 to 15.6
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=34 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=19 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=48 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
n=52 Participants
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
Complete Remission (CR)
|
24 percentage of participants
Interval 10.7 to 41.2
|
16 percentage of participants
Interval 3.4 to 39.6
|
19 percentage of participants
Interval 8.9 to 32.6
|
12 percentage of participants
Interval 4.4 to 23.4
|
—
|
|
Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
Partial Remission (PR)
|
18 percentage of participants
Interval 6.8 to 34.5
|
11 percentage of participants
Interval 1.3 to 33.1
|
25 percentage of participants
Interval 13.6 to 39.6
|
19 percentage of participants
Interval 9.6 to 32.5
|
—
|
|
Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
Disease Control Rate (CR+PR+SD)
|
59 percentage of participants
Interval 40.7 to 75.4
|
63 percentage of participants
Interval 38.4 to 83.7
|
69 percentage of participants
Interval 53.7 to 81.3
|
42 percentage of participants
Interval 28.7 to 56.8
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All participants who received treatment with brentuximab vedotin monotherapy.
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=35 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=68 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=53 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Deaths (Within 30 Days of Last Dose)
|
3 participants
|
5 participants
|
6 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Chemistry Laboratory Abnormalities >/= Grade 3
|
8 participants
|
16 participants
|
10 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Any TEAE
|
32 participants
|
66 participants
|
52 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
TEAE Related to Study Drug
|
28 participants
|
62 participants
|
39 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
TEAE With Severity Grade >/=3
|
23 participants
|
52 participants
|
37 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Discontinued Treatment Due To Adverse Event
|
6 participants
|
7 participants
|
4 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Serious Adverse Event
|
15 participants
|
34 participants
|
22 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Serious Adverse Event Related to Study Drug
|
5 participants
|
15 participants
|
7 participants
|
—
|
—
|
|
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Hematology Laboratory Abnormalities >/= Grade 3
|
11 participants
|
31 participants
|
21 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.
End of infusion concentration of ADC following the first dose of brentuximab vedotin
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=32 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=63 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=50 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)
|
35.6 ug/mL
Geometric Coefficient of Variation 25
|
40.0 ug/mL
Geometric Coefficient of Variation 29
|
40.1 ug/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.
Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=25 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=44 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=34 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)
|
0.44 ug/mL
Geometric Coefficient of Variation 113
|
0.91 ug/mL
Geometric Coefficient of Variation 119
|
0.86 ug/mL
Geometric Coefficient of Variation 94
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.
Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=35 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=68 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=51 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)
|
4.71 ng/mL
Geometric Coefficient of Variation 63
|
4.66 ng/mL
Geometric Coefficient of Variation 88
|
3.95 ng/mL
Geometric Coefficient of Variation 74
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.
Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=35 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=68 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=51 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
|
1.90 days
Interval 0.88 to 6.89
|
1.91 days
Interval 0.91 to 20.9
|
1.94 days
Interval 0.93 to 19.8
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.
Serum concentration of soluble CD30 before first dose of brentuximab vedotin
Outcome measures
| Measure |
CD30+ T-Cell NHL, BV
n=32 Participants
Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
|
CD30+ Other B-Cell NHL, BV
n=64 Participants
Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
|
CD30+ DLBCL, BV
n=46 Participants
Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
|
CD30u DLBCL, BV
Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
|
CD30+ DLBCL, BV+R
|
|---|---|---|---|---|---|
|
Baseline Soluble CD30 Expression
|
1005.4 ng/mL
Interval 89.4 to 26426.6
|
229.4 ng/mL
Interval 33.2 to 21277.7
|
140.4 ng/mL
Interval 53.4 to 1695.9
|
—
|
—
|
Adverse Events
CD30+ NHL (T-Cell and B-Cell), BV
Serious events: 49 serious events
Other events: 96 other events
Deaths: 0 deaths
CD30u DLBCL, BV
Serious events: 22 serious events
Other events: 48 other events
Deaths: 0 deaths
CD30+ DLBCL, BV+R
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD30+ NHL (T-Cell and B-Cell), BV
n=103 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
|
CD30u DLBCL, BV
n=53 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
|
CD30+ DLBCL, BV+R
n=16 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
7.8%
8/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Sepsis
|
3.9%
4/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Cellulitis
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Central nervous system abscess
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Clostridium difficile colitis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Herpes zoster disseminated
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Infection
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Lung infection
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Mastoiditis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Peritonitis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Skin infection
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
5.8%
6/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
11.3%
6/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-cell lymphoma
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
3.9%
4/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
3/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
3/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
3/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Pyrexia
|
8.7%
9/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Asthenia
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Chest pain
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Multi-organ failure
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Pain
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Systemic inflammatory response syndrome
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.9%
4/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hypomagnasemia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar hemorrhage
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
4.9%
5/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Renal and urinary disorders
Renal failure
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Dizziness
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Headache
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Amnesia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Brain mass
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Seizure
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Confusional state
|
2.9%
3/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Delirium
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Hallucination, visual
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Cardiac disorders
Tachycardia
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Investigations
Lipase increased
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Investigations
Liver function test abnormal
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Immune system disorders
Graft versus host disease
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Vascular disorders
Superior vena cava syndrome
|
0.97%
1/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
Other adverse events
| Measure |
CD30+ NHL (T-Cell and B-Cell), BV
n=103 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
|
CD30u DLBCL, BV
n=53 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
|
CD30+ DLBCL, BV+R
n=16 participants at risk
Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.4%
19/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
15.1%
8/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.1%
31/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
24.5%
13/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
37.5%
6/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.8%
8/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
9.4%
5/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Cardiac disorders
Tachycardia
|
4.9%
5/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
6/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
7.5%
4/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
14/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
15.1%
8/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
12.5%
2/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
18.4%
19/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
28.3%
15/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
12.5%
2/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
32.0%
33/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
17.0%
9/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
25.0%
4/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
27.2%
28/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
32.1%
17/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
50.0%
8/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Gastrointestinal disorders
Vomting
|
18.4%
19/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
20.8%
11/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
37.5%
6/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Asthenia
|
9.7%
10/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Chills
|
10.7%
11/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
25.0%
4/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Fatigue
|
41.7%
43/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
32.1%
17/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
25.0%
4/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Edema peripheral
|
10.7%
11/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
7.5%
4/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
12.5%
2/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
General disorders
Pyrexia
|
21.4%
22/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
22.6%
12/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
31.2%
5/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
10/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
9.4%
5/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
13.2%
7/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Investigations
Weight decreased
|
11.7%
12/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
11.3%
6/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.3%
23/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
17.0%
9/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
7/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.7%
12/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
11.3%
6/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.7%
10/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.9%
5/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
7.5%
4/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
10/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
1.9%
1/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
9/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
4/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Dizziness
|
5.8%
6/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
9.4%
5/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
12.5%
2/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Dysgeusia
|
5.8%
6/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Headache
|
12.6%
13/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
11.3%
6/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Hypoesthesia
|
6.8%
7/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.8%
7/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
0.00%
0/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.0%
33/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
26.4%
14/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
37.5%
6/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Anxiety
|
9.7%
10/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Psychiatric disorders
Insomnia
|
13.6%
14/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
13.2%
7/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
17/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.6%
13/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
7.5%
4/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
7/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
3.8%
2/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
7/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
5.7%
3/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
18.8%
3/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.8%
8/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
15.1%
8/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
6.2%
1/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.6%
13/103 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
9.4%
5/53 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
25.0%
4/16 • Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60