Trial Outcomes & Findings for Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma (NCT NCT01771107)
NCT ID: NCT01771107
Last Updated: 2025-08-15
Results Overview
Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
28 days
Results posted on
2025-08-15
Participant Flow
Participant milestones
| Measure |
Phase I - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 m/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
35
|
|
Overall Study
COMPLETED
|
5
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
| Measure |
Phase I - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 m/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
participant moved
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I - Brentuximab 1.2 mg/kg
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
26 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Participants entered into the phase I portion of the study
Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)
|
1.2 mg/kg
|
—
|
PRIMARY outcome
Timeframe: 2 years2-year PFS is determined based on the Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
2-year Progression-free Survival (PFS) (Phase II)
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.878 proportion of participants
Interval 0.706 to 0.953
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants who were treated with brentuximab and combination chemotherapy
Number of Participants who had one or more adverse events
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Frequency of Adverse Events
|
6 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who completed therapy
Number of participants who achieved a partial response per RECIST v1.0 criteria
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Partial Response Rate
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 yearsNumber of participants who achieved a partial response per RECIST v1.0 criteria
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Partial Response Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants who experienced a complete response per RECIST v1.0 criteria
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Complete Response Rate
|
6 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 5 yearsNumber of participants who achieved a complete response per RECIST v1.0 criteria
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Complete Response Rate
|
6 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 2 yearsProportion of study participants who are alive at 2 years estimated using the Kaplan-Meier survival function
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
2-year Overall Survival
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.91 proportion of participants
Interval 0.74 to 0.97
|
SECONDARY outcome
Timeframe: 5 yearsProportion of participants who are alive at 5 years using a Kaplan-Meier estimate
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Overall Survival
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.876 proportion of participants
Interval 0.7 to 0.952
|
SECONDARY outcome
Timeframe: 2 yearsProportion of participants who are alive and progression-free at 2 years
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Event-free Survival
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.878 proportion of participants
Interval 0.706 to 0.953
|
SECONDARY outcome
Timeframe: 5 yearsBinomial probabilities and their 95% confidence intervals will be used to estimate the response rates (i.e., partial response rate, complete response rate, overall response rate) and event free survival at 2 and 5 years of AVD and brentuximab vedotin for a treatment of patients with stage III/IV HIV-associated Hodgkin lymphoma.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Event-free Survival
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.743 proportion of participants
Interval 0.55 to 0.863
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Participants with absolute cd4 counts at cycle 5
CD4 counts (absolute) at visit 4 (cycle 5)
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=26 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
CD4 Counts
|
378 cells/µL
Interval 289.0 to 530.0
|
401 cells/µL
Interval 292.0 to 481.0
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Participants with absolute CD8 counts at cycle 5
Absolute CD8 counts at cycle 5
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=26 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
CD8 Counts
|
719.5 cells/µL
Interval 596.0 to 883.0
|
666.5 cells/µL
Interval 470.0 to 954.0
|
SECONDARY outcome
Timeframe: 5 monthsHIV viral load (detectable)
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=5 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=27 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Viral Load
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: PET-CT positive status was used within each arm.
Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Prognostic Value of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography (PET) in Patient With HIV and Hodgkin Lymphoma (HL) With Respect to 2 Year Progression Free Survival
PET-CT positive
|
0.876 proportion of participants
Interval 0.701 to 0.951
|
0.876 proportion of participants
Interval 0.701 to 0.951
|
|
Prognostic Value of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography (PET) in Patient With HIV and Hodgkin Lymphoma (HL) With Respect to 2 Year Progression Free Survival
PET-CT negative
|
—
|
0 proportion of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: PET-CT positive status was used within each arm.
Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=32 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
PET-CT positive
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
|
Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
PET-CT negative
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.897 proportion of participants
Interval 0.714 to 0.966
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: PET-CT positive status was used within each arm.
Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=5 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=28 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
PET-CT positive
|
—
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
|
Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
PET-CT negative
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.92 proportion of participants
Interval 0.716 to 0.979
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: All participants had HAART at baseline. Logrank test cannot be performed.
Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of progression free survival at 2 years.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
HAART Status
HAART yes
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.878 proportion of participants
Interval 0.706 to 0.953
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: All participant had HAART at baseline. Logrank test cannot be performed.
Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival at 2 years.
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
HAART Status
HAART yes
|
1.0 proportion of participants
Interval 1.0 to 1.0
|
0.911 proportion of participants
Interval 0.747 to 0.97
|
SECONDARY outcome
Timeframe: BaselineParticipants with mixed cellularity histologic subtype in HIV-HL in the HAART era
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=6 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Characterization of Histologic Subtypes in HIV-HL in the HAART Era
|
2 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Participants who had neurotoxicity evaluated at cycle 5
Number of participants who experience neurotoxicity at cycle 5 (visit 4)
Outcome measures
| Measure |
Treatment (Brentuximab and Combination Chemotherapy)
n=4 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=26 Participants
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Incidence of Neurotoxicity
|
4 Participants
|
23 Participants
|
Adverse Events
Phase I - Brentuximab 1.2 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II - Brentuximab 1.2 mg/kg
Serious events: 16 serious events
Other events: 34 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase I - Brentuximab 1.2 mg/kg
n=6 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
General disorders
Death, NOS
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
General disorders
Pain
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
2/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/6 • 2 years
|
2.9%
1/35 • 2 years
|
Other adverse events
| Measure |
Phase I - Brentuximab 1.2 mg/kg
n=6 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
Phase II - Brentuximab 1.2 mg/kg
n=35 participants at risk
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Pharmacological Study: Correlative studies
Vinblastine: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • 2 years
|
48.6%
17/35 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 2 years
|
37.1%
13/35 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • 2 years
|
22.9%
8/35 • 2 years
|
|
Gastrointestinal disorders
Oral mucositis
|
16.7%
1/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • 2 years
|
31.4%
11/35 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 2 years
|
17.1%
6/35 • 2 years
|
|
General disorders
Chills
|
0.00%
0/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
General disorders
Fatigue
|
33.3%
2/6 • 2 years
|
31.4%
11/35 • 2 years
|
|
General disorders
Fever
|
16.7%
1/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
General disorders
Pain
|
16.7%
1/6 • 2 years
|
20.0%
7/35 • 2 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Investigations
alanine aminotransferase increased
|
33.3%
2/6 • 2 years
|
17.1%
6/35 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
3/6 • 2 years
|
20.0%
7/35 • 2 years
|
|
Investigations
Blood albumin increased
|
0.00%
0/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • 2 years
|
25.7%
9/35 • 2 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • 2 years
|
48.6%
17/35 • 2 years
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • 2 years
|
22.9%
8/35 • 2 years
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • 2 years
|
37.1%
13/35 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Investigations
Hyperglycemia
|
33.3%
2/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
33.3%
2/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
2/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • 2 years
|
45.7%
16/35 • 2 years
|
|
Psychiatric disorders
Anxiety
|
50.0%
3/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • 2 years
|
8.6%
3/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 2 years
|
17.1%
6/35 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • 2 years
|
17.1%
6/35 • 2 years
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
50.0%
3/6 • 2 years
|
11.4%
4/35 • 2 years
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
General disorders
Non-cardiac pain
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Immune system disorders
Allergic reaction
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Infections and infestations
Shingles
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • 2 years
|
14.3%
5/35 • 2 years
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
16.7%
1/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Investigations
Weight gain
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Investigations
Weight loss
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle cramp
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • 2 years
|
2.9%
1/35 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • 2 years
|
5.7%
2/35 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • 2 years
|
0.00%
0/35 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60