Trial Outcomes & Findings for Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma (NCT NCT01476410)
NCT ID: NCT01476410
Last Updated: 2026-05-22
Results Overview
The primary objective of this study is to evaluate the complete remission rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 months
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
SGN-35 Lead-In
STARTED
|
49
|
|
SGN-35 Lead-In
Cycle 1
|
48
|
|
SGN-35 Lead-In
Cycle 2
|
46
|
|
SGN-35 Lead-In
COMPLETED
|
43
|
|
SGN-35 Lead-In
NOT COMPLETED
|
6
|
|
AVD
STARTED
|
43
|
|
AVD
Cycle 1
|
43
|
|
AVD
Cycle 2
|
42
|
|
AVD
Cycle 3
|
42
|
|
AVD
Cycle 4
|
41
|
|
AVD
Cycle 5
|
40
|
|
AVD
Cycle 6
|
39
|
|
AVD
COMPLETED
|
35
|
|
AVD
NOT COMPLETED
|
8
|
|
SGN-35 Consolidation
STARTED
|
35
|
|
SGN-35 Consolidation
Cycle 1
|
35
|
|
SGN-35 Consolidation
Cycle 2
|
33
|
|
SGN-35 Consolidation
Cycle 3
|
28
|
|
SGN-35 Consolidation
Cycle 4
|
24
|
|
SGN-35 Consolidation
COMPLETED
|
24
|
|
SGN-35 Consolidation
NOT COMPLETED
|
11
|
|
Post Therapy Follow Up - 3 Years
STARTED
|
48
|
|
Post Therapy Follow Up - 3 Years
COMPLETED
|
33
|
|
Post Therapy Follow Up - 3 Years
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
SGN-35 Lead-In
Adverse Event
|
3
|
|
SGN-35 Lead-In
Withdrawal by Subject
|
2
|
|
SGN-35 Lead-In
Death
|
1
|
|
AVD
Withdrawal by Subject
|
1
|
|
AVD
Adverse Event
|
4
|
|
AVD
Lack of Efficacy
|
3
|
|
SGN-35 Consolidation
Withdrawal by Subject
|
1
|
|
SGN-35 Consolidation
Adverse Event
|
9
|
|
SGN-35 Consolidation
Lack of Efficacy
|
1
|
|
Post Therapy Follow Up - 3 Years
Death
|
4
|
|
Post Therapy Follow Up - 3 Years
Withdrawal by Subject
|
4
|
|
Post Therapy Follow Up - 3 Years
Lost to Follow-up
|
7
|
Baseline Characteristics
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Age, Customized
60-70 years
|
25 Participants
n=2 Participants
|
|
Age, Customized
71-80 years
|
15 Participants
n=2 Participants
|
|
Age, Customized
>80 years
|
8 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=2 Participants
|
|
Histology
Nodular Sclerosis
|
22 Participants
n=2 Participants
|
|
Histology
Mixed Cellularity
|
12 Participants
n=2 Participants
|
|
Histology
Classic, not otherwise specified
|
12 Participants
n=2 Participants
|
|
Histology
Lymphocyte Rich
|
2 Participants
n=2 Participants
|
|
ECOG Performance Score
0
|
19 Participants
n=2 Participants
|
|
ECOG Performance Score
1
|
20 Participants
n=2 Participants
|
|
ECOG Performance Score
2
|
9 Participants
n=2 Participants
|
|
Presence of B symptoms?
Yes
|
18 Participants
n=2 Participants
|
|
Presence of B symptoms?
No
|
30 Participants
n=2 Participants
|
|
Albumin less than 4.0 g/dL
Yes
|
22 Participants
n=2 Participants
|
|
Albumin less than 4.0 g/dL
No
|
26 Participants
n=2 Participants
|
|
International Prognostic Score
0-2
|
20 Participants
n=2 Participants
|
|
International Prognostic Score
3-7
|
28 Participants
n=2 Participants
|
|
Bone Marrow Involvement
Yes
|
11 Participants
n=2 Participants
|
|
Bone Marrow Involvement
No
|
37 Participants
n=2 Participants
|
|
Bulky Disease (greater than or equal to 10 cm)
Yes
|
5 Participants
n=2 Participants
|
|
Bulky Disease (greater than or equal to 10 cm)
No
|
43 Participants
n=2 Participants
|
|
Hodgkin's Lymphoma Stage
II
|
9 Participants
n=2 Participants
|
|
Hodgkin's Lymphoma Stage
III
|
18 Participants
n=2 Participants
|
|
Hodgkin's Lymphoma Stage
IV
|
21 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 monthsPopulation: 6 patients did not complete the 2 lead-in doses of SGN-35 and 3 cycles of AVD and are therefore not evaluable
The primary objective of this study is to evaluate the complete remission rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=42 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Complete Remission Rate After Chemotherapy
|
38 Participants
|
SECONDARY outcome
Timeframe: 2 cycles of SGN-35 lead-in therapy, approximately 42 daysThe incidence of overall response rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=22 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Overall Response Rate After 2 Cycles of SGN-35
|
18 Participants
|
SECONDARY outcome
Timeframe: 2 cycles of lead-in SGN-35, approximately 42 daysThe incidence of CR rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=22 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Complete Remission Rate Following 2 Cycles of SGN-35
|
8 Participants
|
SECONDARY outcome
Timeframe: From time of treatment to 30 days after discontinuation of study treatmentDetailed examination of Averse Events, laboratory test results, vital signs or other physical findings. Below we have summarized the top 10 most common Grade 3 and Grade 4 related adverse events. Please see the Adverse Events section of this record for a full listing of Adverse Events.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Febrile Neutropenia
|
4 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Pneumonia
|
3 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Diarrhea
|
3 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Neutropenia
|
21 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Lymphopenia
|
4 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Leukopenia
|
4 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Increased Transaminases
|
2 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Muscle Weakness
|
2 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Peripheral Neuropathy (sensory)
|
2 participants
|
|
Safety of Sequential SGN-35/AVD/SGN-35 Therapy
Fatigue
|
2 participants
|
SECONDARY outcome
Timeframe: 2 years from time of registration to studyProgression Free Survival (PFS) is defined as lymphoma progression or death from any cause. This outcome measure is the percentage of patients that have not progressed at 2 years from time of registration.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
2-year Progression Free Survival
|
84 percentage of patients
Interval 69.0 to 92.0
|
SECONDARY outcome
Timeframe: up to 2 years from the time of registrationDefined as the percentage of patients that are alive 2 years after registration.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Overall Survival Following SGN-35/AVD Sequential Therapy
|
93 percentage of patients
Interval 80.0 to 98.0
|
SECONDARY outcome
Timeframe: From registration until treatment failure, up to 2 yearsAn event is defined as treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death. This outcome measure is reported as the percentage of patient that did not have an event at 2 years from registration.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
2 Year Event-Free Survival
|
80 percentage of patients
Interval 65.0 to 89.0
|
SECONDARY outcome
Timeframe: from baseline to end of study, approximately 4 yearsPopulation: We did not collect the appropriate data to analyze this endpoint. Please see progression free survival endpoint
Measured from the time of study entry to progression of disease. Other causes of treatment failure are not include in freedom from progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and AVD Cycle 1, a total of 6 weeksEvaluate patient reported outcomes at baseline and during treatment to determine potential symptom palliation, treatment-related symptoms, and overall health-related quality of life. The Function Assessment of Cancer Therapy for Lymphoma (FACT-Lym) scale has a range of 0(minimum score) to 168 (maximum score). Higher scores indicate a better outcome. The mean scores for each timepoint are reported below.
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=34 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Patient Reported Outcomes for Symptoms and Quality of Life
AVD Cycle 1
|
134.07 score on a scale
Standard Deviation 21.46
|
|
Patient Reported Outcomes for Symptoms and Quality of Life
Baseline
|
128.29 score on a scale
Standard Deviation 25.45
|
SECONDARY outcome
Timeframe: approximately 2 years from treatment startPopulation: Only 44 patients were analyzed for this endpoint because there were 4 patients where the CIRS score at baseline was unknown.
Number of co-morbidities collected for each patient at baseline and at the end of completion of all therapy utilizing the Cumulative Illness Rating Scare (CIRS). For binary outcomes such as CR, logistic regression will be used to assess the relationship with CIRS score; for time-to-event outcomes, the method of Kalan Meier and the log rank test will be used. The minimum score of the CIRS is 0 and the maximum score is 56. High Scores on the CIRS scale indicate that the patient has more severe comorbidities
Outcome measures
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=44 Participants
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin: Given IV
doxorubicin hydrochloride: Given IV
vinblastine: Given IV
dacarbazine: Given IV
quality-of-life assessment: Ancillary studies
DNA analysis: Optional correlative studies
RNA analysis: Optional correlative studies
fludeoxyglucose F 18: Correlative studies
positron emission tomography: Correlative studies
laboratory biomarker analysis: Optional correlative studies
immunohistochemistry staining method: Optional correlative studies
polymorphism analysis: Optional correlative studies
|
|---|---|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Event Free Survival : CIRS High (score greater than or equal to 10)
|
38 percentage of participants
Interval 13.0 to 63.0
|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Event Free Survival : CIRS Low (score less than 10)
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Progression Free Survival : CIRS High (score greater than or equal to 10)
|
45 percentage of participants
Interval 15.0 to 71.0
|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Progression Free Survival : CIRS Low (score less than 10)
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Overall Survival : CIRS High (score greater than or equal to 10)
|
81 percentage of participants
Interval 41.0 to 95.0
|
|
Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes
2-year Overall Survival : CIRS Low (score less than 10)
|
100 percentage of participants
Interval 100.0 to 100.0
|
Adverse Events
Treatment (Antibody-drug Conjugate and Combination Chemo)
Serious events: 20 serious events
Other events: 46 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 participants at risk
There is only 1 Arm/Group for this study and each patient receives the same treatment: Lead-In therapy followed by AVD chemotherapy and Consolidation treatment. A secondary endpoint for this study was the safety of the sequential therapy, so toxicity data was collected and reported as a combined dataset for the whole sequential regimen. The data was not split into individual interventions.
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.1%
1/48 • 7 years, 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • 7 years, 9 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
2/48 • 7 years, 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • 7 years, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
3/48 • 7 years, 9 months
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • 7 years, 9 months
|
|
Gastrointestinal disorders
Pancreatitis
|
4.2%
2/48 • 7 years, 9 months
|
|
General disorders
Chills
|
2.1%
1/48 • 7 years, 9 months
|
|
General disorders
Fatigue
|
2.1%
1/48 • 7 years, 9 months
|
|
General disorders
Fever
|
4.2%
2/48 • 7 years, 9 months
|
|
General disorders
Gait disturbance
|
2.1%
1/48 • 7 years, 9 months
|
|
General disorders
Infusion related reaction
|
4.2%
2/48 • 7 years, 9 months
|
|
Hepatobiliary disorders
Hepatic failure
|
2.1%
1/48 • 7 years, 9 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.1%
1/48 • 7 years, 9 months
|
|
Infections and infestations
Bladder infection
|
2.1%
1/48 • 7 years, 9 months
|
|
Infections and infestations
Bone infection
|
2.1%
1/48 • 7 years, 9 months
|
|
Infections and infestations
Lung infection
|
2.1%
1/48 • 7 years, 9 months
|
|
Infections and infestations
Soft tissue infection
|
4.2%
2/48 • 7 years, 9 months
|
|
Infections and infestations
Tooth infection
|
2.1%
1/48 • 7 years, 9 months
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • 7 years, 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
2/48 • 7 years, 9 months
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • 7 years, 9 months
|
|
Investigations
Alkaline phosphatase increased
|
2.1%
1/48 • 7 years, 9 months
|
|
Investigations
Blood bilirubin increased
|
2.1%
1/48 • 7 years, 9 months
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/48 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.1%
1/48 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
2/48 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.1%
1/48 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.1%
1/48 • 7 years, 9 months
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • 7 years, 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.1%
1/48 • 7 years, 9 months
|
|
Nervous system disorders
Stroke
|
4.2%
2/48 • 7 years, 9 months
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • 7 years, 9 months
|
|
Psychiatric disorders
Confusion
|
4.2%
2/48 • 7 years, 9 months
|
|
Psychiatric disorders
Hallucinations
|
2.1%
1/48 • 7 years, 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/48 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/48 • 7 years, 9 months
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • 7 years, 9 months
|
Other adverse events
| Measure |
Treatment (Antibody-drug Conjugate and Combination Chemo)
n=48 participants at risk
There is only 1 Arm/Group for this study and each patient receives the same treatment: Lead-In therapy followed by AVD chemotherapy and Consolidation treatment. A secondary endpoint for this study was the safety of the sequential therapy, so toxicity data was collected and reported as a combined dataset for the whole sequential regimen. The data was not split into individual interventions.
|
|---|---|
|
Investigations
Creatinine increased
|
10.4%
5/48 • Number of events 5 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
5/48 • Number of events 7 • 7 years, 9 months
|
|
Psychiatric disorders
Delirium
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Psychiatric disorders
Depression
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
18/48 • Number of events 30 • 7 years, 9 months
|
|
Nervous system disorders
Dizziness
|
27.1%
13/48 • Number of events 21 • 7 years, 9 months
|
|
Eye disorders
Dry eye
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
5/48 • Number of events 6 • 7 years, 9 months
|
|
Nervous system disorders
Dysesthesia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
Dysgeusia
|
14.6%
7/48 • Number of events 8 • 7 years, 9 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.4%
5/48 • Number of events 6 • 7 years, 9 months
|
|
Gastrointestinal disorders
Dysphagia
|
10.4%
5/48 • Number of events 5 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
18/48 • Number of events 25 • 7 years, 9 months
|
|
General disorders
Edema limbs
|
10.4%
5/48 • Number of events 7 • 7 years, 9 months
|
|
Investigations
Ejection fraction decreased
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
4/48 • Number of events 4 • 7 years, 9 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
eye irritation
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
erythema of R scelerae
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
Presbyopia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
Altered Depth Perception
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
Red eyes, blepharitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
General disorders
Fatigue
|
66.7%
32/48 • Number of events 63 • 7 years, 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
General disorders
Fever
|
18.8%
9/48 • Number of events 11 • 7 years, 9 months
|
|
Eye disorders
Flashing lights
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Eye disorders
Floaters
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Gait disturbance
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Gastritis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.6%
7/48 • Number of events 9 • 7 years, 9 months
|
|
Gastrointestinal disorders
Hyperpigmentation of tongue
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
oral bleeding
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Flare of diverticulitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Night Sweats
|
2.1%
1/48 • Number of events 2 • 7 years, 9 months
|
|
General disorders
hot flashes
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Vein pain (left arm)
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Left medial thigh pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Left Toe Pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
leg cramping
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
hand cramping
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
head cold
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
scab like area at port
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.4%
5/48 • Number of events 6 • 7 years, 9 months
|
|
Reproductive system and breast disorders
Genital edema
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
Headache
|
14.6%
7/48 • Number of events 7 • 7 years, 9 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
9/48 • Number of events 32 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Vascular disorders
Hypertension
|
10.4%
5/48 • Number of events 12 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.9%
11/48 • Number of events 22 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
6/48 • Number of events 9 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
4/48 • Number of events 6 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
9/48 • Number of events 23 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Vascular disorders
Hypotension
|
10.4%
5/48 • Number of events 5 • 7 years, 9 months
|
|
Immune system disorders
Hypersensitivity to chemo
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Fungal Oral Infection
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Infusion related reaction
|
6.2%
3/48 • Number of events 4 • 7 years, 9 months
|
|
Psychiatric disorders
Insomnia
|
12.5%
6/48 • Number of events 10 • 7 years, 9 months
|
|
General disorders
Irritability
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Investigations
Lipase increased
|
2.1%
1/48 • Number of events 3 • 7 years, 9 months
|
|
Infections and infestations
Lung infection
|
8.3%
4/48 • Number of events 4 • 7 years, 9 months
|
|
Investigations
Lymphocyte count decreased
|
22.9%
11/48 • Number of events 29 • 7 years, 9 months
|
|
Investigations
Lymphocyte count increased
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Malaise
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Mucosal infection
|
8.3%
4/48 • Number of events 5 • 7 years, 9 months
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
8/48 • Number of events 8 • 7 years, 9 months
|
|
General disorders
Multi-organ failure
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
toe cramping, bilateral
|
2.1%
1/48 • Number of events 2 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
spinal canal stenosis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Right Elbow Bursitis with Erythema and Swelling
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Tongue pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Left thigh pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Chest pressure
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
9/48 • Number of events 10 • 7 years, 9 months
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Nail infection
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
24/48 • Number of events 45 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm of uncertain behavior of skin
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
tongue tingling
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
lip tingling
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Investigations
Neutrophil count decreased
|
50.0%
24/48 • Number of events 77 • 7 years, 9 months
|
|
General disorders
Non-cardiac chest pain
|
2.1%
1/48 • Number of events 2 • 7 years, 9 months
|
|
Gastrointestinal disorders
Oral pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Otitis externa
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Pain
|
16.7%
8/48 • Number of events 13 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Palpitations
|
8.3%
4/48 • Number of events 4 • 7 years, 9 months
|
|
Infections and infestations
Pelvic infection
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
4/48 • Number of events 7 • 7 years, 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.4%
29/48 • Number of events 70 • 7 years, 9 months
|
|
Infections and infestations
Pharyngitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Vascular disorders
Phlebitis
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Investigations
Platelet count decreased
|
14.6%
7/48 • Number of events 16 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Renal and urinary disorders
Proteinuria
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
12/48 • Number of events 16 • 7 years, 9 months
|
|
Psychiatric disorders
stress
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.8%
10/48 • Number of events 13 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
dry nose
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Rhinitis infective
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Nervous system disorders
Seizure
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Investigations
Serum amylase increased
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Sinus bradycardia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Sinus tachycardia
|
14.6%
7/48 • Number of events 8 • 7 years, 9 months
|
|
Infections and infestations
Sinusitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
nail changes
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Folliculitis (upper left extremity)
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Left axillary abscess
|
2.1%
1/48 • Number of events 2 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Seborrheic Keratoses
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Foot Fungal Rash
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin lesions on chest and left shoulder
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
sweet syndrome lesion on right wrist
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
actinic keratoses
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Ptosis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash on bilateral upper extremities
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
lesions on the R arm and upper back
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Skin infection
|
4.2%
2/48 • Number of events 4 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
Stroke
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Vascular disorders
Superficial thrombophlebitis
|
8.3%
4/48 • Number of events 4 • 7 years, 9 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Surgical and medical procedures
Upper left molar tooth extraction
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Surgical and medical procedures
Seborrheic Keratoses Excision
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 2 • 7 years, 9 months
|
|
Vascular disorders
Thromboembolic event
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Gastrointestinal disorders
Toothache
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Upper respiratory infection
|
10.4%
5/48 • Number of events 6 • 7 years, 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Renal and urinary disorders
Urinary retention
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Infections and infestations
Urinary tract infection
|
4.2%
2/48 • Number of events 5 • 7 years, 9 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Renal and urinary disorders
Urine discoloration
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
4/48 • Number of events 4 • 7 years, 9 months
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
9/48 • Number of events 10 • 7 years, 9 months
|
|
Eye disorders
Watering eyes
|
4.2%
2/48 • Number of events 2 • 7 years, 9 months
|
|
Investigations
Weight gain
|
8.3%
4/48 • Number of events 9 • 7 years, 9 months
|
|
Investigations
Weight loss
|
14.6%
7/48 • Number of events 11 • 7 years, 9 months
|
|
Investigations
White blood cell decreased
|
29.2%
14/48 • Number of events 47 • 7 years, 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
8/48 • Number of events 13 • 7 years, 9 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
4/48 • Number of events 7 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
5/48 • Number of events 8 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
6/48 • Number of events 13 • 7 years, 9 months
|
|
Nervous system disorders
Ataxia
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Cardiac disorders
Atrial flutter
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
6/48 • Number of events 7 • 7 years, 9 months
|
|
Infections and infestations
Bladder infection
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Investigations
Blood bilirubin increased
|
4.2%
2/48 • Number of events 10 • 7 years, 9 months
|
|
Eye disorders
Blurred vision
|
22.9%
11/48 • Number of events 14 • 7 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.6%
7/48 • Number of events 10 • 7 years, 9 months
|
|
Infections and infestations
Bronchial infection
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Eye disorders
Cataract
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
General disorders
Chills
|
12.5%
6/48 • Number of events 6 • 7 years, 9 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.2%
2/48 • Number of events 4 • 7 years, 9 months
|
|
Nervous system disorders
Concentration impairment
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Psychiatric disorders
Confusion
|
12.5%
6/48 • Number of events 8 • 7 years, 9 months
|
|
Eye disorders
Conjunctivitis
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Constipation
|
41.7%
20/48 • Number of events 46 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
18/48 • Number of events 24 • 7 years, 9 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.9%
11/48 • Number of events 14 • 7 years, 9 months
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
4/48 • Number of events 6 • 7 years, 9 months
|
|
Psychiatric disorders
Agitation
|
2.1%
1/48 • Number of events 1 • 7 years, 9 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
4/48 • Number of events 6 • 7 years, 9 months
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
12/48 • Number of events 23 • 7 years, 9 months
|
|
Immune system disorders
Allergic reaction
|
2.1%
1/48 • Number of events 7 • 7 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
3/48 • Number of events 3 • 7 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
9/48 • Number of events 14 • 7 years, 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
41.7%
20/48 • Number of events 48 • 7 years, 9 months
|
Additional Information
Dr. Leo Gordon
Northwestern University, Feinberg School of Medicine
Phone: 312-695-0990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place