Trial Outcomes & Findings for Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma (NCT NCT03331341)
NCT ID: NCT03331341
Last Updated: 2025-08-05
Results Overview
Number of participants who complete 2 cycles of treatment without a dose delay of \>3 weeks. Toxicity leading to dose delay will be assessed using CTCAE v5.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At the end of Cycle 2 (each cycle is 28 days)
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Treatment (APVD)
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (APVD)
n=50 Participants
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 2 (each cycle is 28 days)Number of participants who complete 2 cycles of treatment without a dose delay of \>3 weeks. Toxicity leading to dose delay will be assessed using CTCAE v5.0.
Outcome measures
| Measure |
Treatment (APVD)
n=30 Participants
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
PART A: Number of Participants Who Complete of 2 Cycles of Adriamycin, Pembrolizumab, Vinblastine and Dacarbazine (APVD)
|
30 Participants
|
PRIMARY outcome
Timeframe: At the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)Number of participants who are event free at 1 year. An event is defined as progression, biopsy proven recurrence, initiation of next line of chemotherapy, or death.
Outcome measures
| Measure |
Treatment (APVD)
n=50 Participants
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
PART B: Event Free Survival at 1 Year
|
49 Participants
|
SECONDARY outcome
Timeframe: After 2 cycles (each cycle is 28 days)The Deauville 5 point scale is scored as follows: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver and/or new lesions; X, new areas of uptake unlikely to be related to lymphoma.
Outcome measures
| Measure |
Treatment (APVD)
n=49 Participants
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
Proportion of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography PET2 Negative (Deauville Score 1-3) Patients After 2 Cycles of APVD
|
30 Participants
|
Adverse Events
Treatment (APVD)
Serious events: 8 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (APVD)
n=50 participants at risk
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
5/50 • Number of events 8 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Infections and infestations
Septic Shock
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Infections and infestations
Skin Infection
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Guillain-Barré syndrome
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/50 • Number of events 1 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
Other adverse events
| Measure |
Treatment (APVD)
n=50 participants at risk
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Dacarbazine: Given IV
Doxorubicin Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Vinblastine: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
14.0%
7/50 • Number of events 9 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Alanine Aminotransferase Increased
|
38.0%
19/50 • Number of events 55 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Alkaline Phosphatase Increased
|
10.0%
5/50 • Number of events 8 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.0%
14/50 • Number of events 14 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Blood and lymphatic system disorders
Anemia
|
48.0%
24/50 • Number of events 45 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Psychiatric disorders
Anxiety
|
8.0%
4/50 • Number of events 4 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
8/50 • Number of events 8 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Asparate Aminotransferase Increased
|
26.0%
13/50 • Number of events 28 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.0%
7/50 • Number of events 7 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Bloating
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Eye disorders
Blurred Vision
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.0%
8/50 • Number of events 11 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Chills
|
16.0%
8/50 • Number of events 8 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Constipation
|
68.0%
34/50 • Number of events 39 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
9/50 • Number of events 11 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Creatinine increased
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Decreased lymphocytes
|
10.0%
5/50 • Number of events 27 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Decreased neutrophil count
|
68.0%
34/50 • Number of events 188 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Decreased white blood cells
|
10.0%
5/50 • Number of events 21 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Diarrhea
|
28.0%
14/50 • Number of events 17 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Dizziness
|
10.0%
5/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Dry mouth
|
12.0%
6/50 • Number of events 6 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
4/50 • Number of events 4 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Dysguesia
|
18.0%
9/50 • Number of events 9 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
5/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
10/50 • Number of events 10 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Edema
|
6.0%
3/50 • Number of events 4 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Fatigue
|
48.0%
24/50 • Number of events 27 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Fever
|
16.0%
8/50 • Number of events 11 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Vascular disorders
Flushing
|
8.0%
4/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.0%
4/50 • Number of events 4 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Headache
|
32.0%
16/50 • Number of events 19 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Vascular disorders
Hot flashes
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.0%
4/50 • Number of events 6 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.0%
6/50 • Number of events 10 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.0%
12/50 • Number of events 15 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
Hyponatremia
|
8.0%
4/50 • Number of events 13 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Endocrine disorders
Hypothyroidism
|
8.0%
4/50 • Number of events 4 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Psychiatric disorders
Insomnia
|
26.0%
13/50 • Number of events 13 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Mucositis oral
|
14.0%
7/50 • Number of events 9 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
5/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Nausea
|
72.0%
36/50 • Number of events 43 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Neuropathy
|
28.0%
14/50 • Number of events 15 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Night sweats
|
6.0%
3/50 • Number of events 3 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Oral pain
|
14.0%
7/50 • Number of events 9 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
General disorders
Pain
|
8.0%
4/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
5/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Paresthesia
|
14.0%
7/50 • Number of events 7 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.0%
7/50 • Number of events 7 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
10/50 • Number of events 12 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.0%
6/50 • Number of events 7 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Nervous system disorders
Syncope
|
8.0%
4/50 • Number of events 5 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
10/50 • Number of events 14 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
14/50 • Number of events 22 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
|
Investigations
White blood count decreased
|
8.0%
4/50 • Number of events 7 • Adverse events are collected beginning with the first dose of treatment through 30 days after last dose, approximately 7 months. All-Cause Mortality was monitored/assessed up to 1 year after completing the 2nd cycle.
|
Additional Information
Dr. Ryan Lynch, Associate Professor
University of Washington
Phone: 206-606-1739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place