Trial Outcomes & Findings for PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Classical Hodgkin Lymphoma (NCT NCT03226249)
NCT ID: NCT03226249
Last Updated: 2023-06-02
Results Overview
To assess the primary objective of response rate following PET #2 performed after 3 doses of pembrolizumab. PET response will be assessed using the Lugano Criteria (2014) which recommends the 5 point Deauville score for assessing response. The Deauville five-point scale is an internationally-recommended scale for routine clinical reporting and clinical trials using FDG PET-CT in the initial staging and assessment of treatment response in Hodgkin lymphoma (HL). Patients with a Deauville score of 1-3 will be considered a complete response. Deauville criteria is defined as follows: 1. No residual uptake 2. Slight uptake, but below blood pool (mediastinum) 3. Uptake above mediastinum, but below or equal to uptake in the liver 4. Uptake slightly to moderately higher than liver 5. Markedly increased uptake or any new lesions Patients will be evaluable for response assessment if they have received at least one dose of pembrolizumab.
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
After 3 cycles of pembrolizumab (1 cycle = 21 days)
Results posted on
2023-06-02
Participant Flow
The study opened to accrual on September 6th, 2017 with an accrual goal of 30 patients. The first patient was enrolled onto the study and started treatment on November 9th, 2017. The study closed permanently to further enrollment of participants on March,12th 2019 as the accrual goal was met.
Participant milestones
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
PEM Induction Cycles 1-3, and PET#2
STARTED
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
PEM Cycle 1
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
PEM Cycle 2
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
PEM Cycle 3
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
PET#2
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
COMPLETED
|
30
|
|
PEM Induction Cycles 1-3, and PET#2
NOT COMPLETED
|
0
|
|
2 Cycles of AVD + PET#3
STARTED
|
30
|
|
2 Cycles of AVD + PET#3
AVD Cycle 1
|
30
|
|
2 Cycles of AVD + PET#3
AVD Cycle 2
|
30
|
|
2 Cycles of AVD + PET#3
PET#3
|
30
|
|
2 Cycles of AVD + PET#3
COMPLETED
|
30
|
|
2 Cycles of AVD + PET#3
NOT COMPLETED
|
0
|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
STARTED
|
30
|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
2-4 Cycles of AVD +/- Chemo & RT
|
29
|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
PET#4
|
29
|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
COMPLETED
|
29
|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
NOT COMPLETED
|
1
|
|
PEM Consolidation (1-2 Years)
STARTED
|
29
|
|
PEM Consolidation (1-2 Years)
COMPLETED
|
0
|
|
PEM Consolidation (1-2 Years)
NOT COMPLETED
|
29
|
|
Survival Follow-up
STARTED
|
30
|
|
Survival Follow-up
COMPLETED
|
0
|
|
Survival Follow-up
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
2-4 Cycles of AVD +/- Chemo & RT, PET#4
Transferred to another state
|
1
|
|
PEM Consolidation (1-2 Years)
Per Protocol not eligible
|
29
|
|
Survival Follow-up
Patients still in follow-up.
|
30
|
Baseline Characteristics
PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 Participants
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Disease Stage
IIa
|
6 Participants
n=5 Participants
|
|
Disease Stage
IIb
|
6 Participants
n=5 Participants
|
|
Disease Stage
IIIa
|
4 Participants
n=5 Participants
|
|
Disease Stage
IIIb
|
1 Participants
n=5 Participants
|
|
Disease Stage
IVa
|
6 Participants
n=5 Participants
|
|
Disease Stage
IVb
|
7 Participants
n=5 Participants
|
|
Bulky vs Non-Bulky Disease
Yes
|
14 Participants
n=5 Participants
|
|
Bulky vs Non-Bulky Disease
No
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 3 cycles of pembrolizumab (1 cycle = 21 days)To assess the primary objective of response rate following PET #2 performed after 3 doses of pembrolizumab. PET response will be assessed using the Lugano Criteria (2014) which recommends the 5 point Deauville score for assessing response. The Deauville five-point scale is an internationally-recommended scale for routine clinical reporting and clinical trials using FDG PET-CT in the initial staging and assessment of treatment response in Hodgkin lymphoma (HL). Patients with a Deauville score of 1-3 will be considered a complete response. Deauville criteria is defined as follows: 1. No residual uptake 2. Slight uptake, but below blood pool (mediastinum) 3. Uptake above mediastinum, but below or equal to uptake in the liver 4. Uptake slightly to moderately higher than liver 5. Markedly increased uptake or any new lesions Patients will be evaluable for response assessment if they have received at least one dose of pembrolizumab.
Outcome measures
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 Participants
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Complete Response (CR) With Pembrolizumab Treatment Alone
|
37 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsTo assess safety and tolerability, all adverse events will be summarized in terms of type, grade, timing and attribution to treatment and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE version 4.03).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPFS for patients \<60 will be measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPFS for elderly patients will be measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsOS for patients \<60 will be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsOS for elderly patients will be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of chemotherapyEvaluate the extent of FDG uptake by assessing PET scans to determine a Deauville score.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: At completion of treatment with 3 cycles of pembrolizumab (21 day cycles) and up to 6 cycles of AVD (28 days cycles)PFS is defined as the number of patients that are progression/relapse free at the time of treatment completion (3 cycles of pembrolizumab and up to 6 cycles of AVD). Progressive or relapse disease is defined as of the following: Appearance of any new lesion more than 1.5 cm in any axis during treatment, even if other lesions are decreasing in size. At least a 50% increased from nadir in the sum of the product of the diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by at least 50% and to a size of more than 1.5 x 1.5 cm or more than 1.5 cm in the long axis. At least a 50% increase in the longest diameter of any single previously identified node more than 1.0 cm in its short axis. Lymphoma confirmed by repeat biopsy.
Outcome measures
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 Participants
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Progression Free Survival (PFS) at Treatment Completion
|
30 Participants
|
POST_HOC outcome
Timeframe: At completion of treatment with 3 cycles of pembrolizumab (21 day cycles) and up to 6 cycles of AVD (28 days cycles)Overall survival will be defined as the number of patients that are alive at the time of treatment completion (3 cycles of pembrolizumab and 2-6 cycles of AVD)
Outcome measures
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 Participants
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Overall Survival at Treatment Completion
|
30 Participants
|
Adverse Events
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 participants at risk
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
2/30 • Number of events 2 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Pericarditis
|
3.3%
1/30 • Number of events 1 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Facial nerve disorder
|
3.3%
1/30 • Number of events 1 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
Other adverse events
| Measure |
Treatment: Pembrolizumab and AVD Chemotherapy Guided by PET-CT
n=30 participants at risk
All patients get 3 cycles (21-days each) of pembrolizumab (PEM) induction, then a PET-CT (PET#2). PET#2 required for primary endpoint analysis. Patients evaluable for response assessment if they had at least one dose of PEM.
After, all patients get 2 cycles (28-days each) of AVD (doxorubicin, vinblastine, dacarbazine), followed by an interim PET-CT (PET#3) for response analysis.
Depending on age, stage, and PET#3 results per Deauville (DV) Score, patients get additional 2-4 cycles of AVD, or AVD and escBEACOPP (escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) + radiotherapy (RT). Then, patients will have a PET-CT (PET#4) or a CT (CT if Stage I/II disease and negative for PET#3).
Patients under 60 go to survival follow-up. Patients over 60 go to survival follow-up or 1-2 years of PEM consolidation based on bulky vs non bulky disease, results of the PET#3, and the number of AVD cycles received.
See schema for details.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
73.3%
22/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Chest pain - cardiac
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Endocrine disorders
Hyperthyroidism
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Blurred vision
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Cataract
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Dry eye
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Eye disorders
Watering eyes
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Constipation
|
66.7%
20/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
9/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
5/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
15/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Nausea
|
76.7%
23/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Rectal pain
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Chills
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Edema limbs
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Fatigue
|
66.7%
20/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Fever
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Flu like symptoms
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Infusion related reaction
|
16.7%
5/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Localized edema
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Malaise
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Non-cardiac chest pain
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
General disorders
Pain
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Immune system disorders
Allergic reaction
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Gum infection
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Mucosal infection
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Pharyngitis
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Rash pustular
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Rhinitis infective
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Sepsis
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Skin infection
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Small intestine infection
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Injury, poisoning and procedural complications
Burn
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Alanine aminotransferase increased
|
36.7%
11/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
12/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Blood bilirubin increased
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
INR increased
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Lymphocyte count decreased
|
60.0%
18/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Neutrophil count decreased
|
93.3%
28/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Weight gain
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
Weight loss
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Investigations
White blood cell decreased
|
93.3%
28/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
10/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
76.7%
23/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
5/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.7%
11/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
9/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.7%
11/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
8/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Ataxia
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Headache
|
33.3%
10/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.7%
8/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Presyncope
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Sinus pain
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Nervous system disorders
Tremor
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Psychiatric disorders
Anxiety
|
20.0%
6/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Psychiatric disorders
Insomnia
|
26.7%
8/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Psychiatric disorders
Restlessness
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Renal and urinary disorders
Urinary urgency
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Irregular menstruation
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
8/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
3/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
10/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
10/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
5/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
8/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.3%
7/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
5/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Vascular disorders
Hot flashes
|
13.3%
4/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Vascular disorders
Hypertension
|
63.3%
19/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Vascular disorders
Phlebitis
|
6.7%
2/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.3%
1/30 • Up to 3 cycles of pembrolizumab (21 day cycles), and up to 6 cycles of AVD (28 day cycles), or approximately 33 weeks.
Adverse event data shown below includes all events collected and available up until March 23rd 2020 for the study. Data collected includes the highest grade of the event experienced for each participant, and thus includes some serious adverse event data. Adverse event data
|
Additional Information
Jane N. Winter, M.D.
Northwestern University, Feinberg School of Medicine
Phone: (312) 695-4538
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place