Trial Outcomes & Findings for A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) (NCT NCT02857426)
NCT ID: NCT02857426
Last Updated: 2021-12-23
Results Overview
Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to approximately 51 months
Results posted on
2021-12-23
Participant Flow
47 PCNSL participants treated. 19 PTL participants treated.
Participant milestones
| Measure |
PCNSL Cohort
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
19
|
Reasons for withdrawal
| Measure |
PCNSL Cohort
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Overall Study
Disease progression
|
34
|
13
|
|
Overall Study
Study drug toxicity
|
4
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse event unrelated to study drug
|
6
|
2
|
|
Overall Study
Participant withdrew consent
|
1
|
1
|
|
Overall Study
Maximum clinical benefit
|
1
|
0
|
|
Overall Study
Completed treatment
|
0
|
2
|
Baseline Characteristics
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Baseline characteristics by cohort
| Measure |
PCNSL Cohort
n=47 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=19 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
66.7 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.1 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 51 monthsPopulation: All treated PCNSL and PTL participants
Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
Outcome measures
| Measure |
PCNSL Cohort
n=47 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=19 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
BICR-Assessed Objective Response Rate (ORR)
|
6.4 Percentage of participants
Interval 1.3 to 17.5
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: All treated PCNSL and PTL participants
Progression-free survival (PFS) is defined as the time from first dosing date to the date of the first documented progression using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
PCNSL Cohort
n=47 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=19 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
BICR-Assessed Progression Free Survival (PFS)
|
1.41 Months
Interval 1.08 to 1.74
|
1.72 Months
Interval 1.15 to 6.28
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: All treated PCNSL and PTL participants
Percentage of participants with a confirmed objective response rate (ORR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
Outcome measures
| Measure |
PCNSL Cohort
n=47 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=19 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Investigator-Assessed Objective Response Rate (ORR)
|
10.6 Percentage of participants
Interval 3.5 to 23.1
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: All responders PCNSL and PTL participants
Duration of response (DOR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
PCNSL Cohort
n=5 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=5 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Investigator-Assessed Duration of Response (DOR)
|
1.71 Months
Interval 0.72 to 7.1
|
20.63 Months
Interval 0.03 to
only 3 DOR event observed
|
SECONDARY outcome
Timeframe: Up to approximately 51 monthsPopulation: All treated PCNSL and PTL participants
Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations. OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
PCNSL Cohort
n=47 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort
n=19 Participants
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Overall Survival (OS)
|
6.77 Months
Interval 3.68 to 11.99
|
11.17 Months
Interval 2.6 to 24.41
|
Adverse Events
PCNSL Cohort Nivolumab 240 mg (Q2W)
Serious events: 33 serious events
Other events: 40 other events
Deaths: 32 deaths
PTL Cohort Nivolumab 240 mg (Q2W)
Serious events: 15 serious events
Other events: 16 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
PCNSL Cohort Nivolumab 240 mg (Q2W)
n=47 participants at risk
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort Nivolumab 240 mg (Q2W)
n=19 participants at risk
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Infections and infestations
Pulmonary sepsis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Sepsis
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Septic shock
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Lymphocyte count decreased
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Platelet count decreased
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Asthenia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Fatigue
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Gait disturbance
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
General physical health deterioration
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Mucosal inflammation
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Pyrexia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Sudden death
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Hepatobiliary disorders
Hepatitis acute
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Influenza
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Meningitis viral
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
27.7%
13/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
42.1%
8/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Brain oedema
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Cognitive disorder
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Depressed level of consciousness
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Encephalopathy
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Epilepsy
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Hemianopia homonymous
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Hemiparesis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Hemiplegia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Mental impairment
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Nervous system disorder
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Neurological decompensation
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Seizure
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Confusional state
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Mental status changes
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
Other adverse events
| Measure |
PCNSL Cohort Nivolumab 240 mg (Q2W)
n=47 participants at risk
Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
PTL Cohort Nivolumab 240 mg (Q2W)
n=19 participants at risk
Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL).
Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
27.7%
13/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Cardiac disorders
Bradycardia
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Ear and labyrinth disorders
Vertigo
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Eye irritation
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Glaucoma
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Pupils unequal
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Eye disorders
Vision blurred
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Constipation
|
17.0%
8/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
21.1%
4/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Dysphagia
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Nausea
|
12.8%
6/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Gastrointestinal disorders
Vomiting
|
14.9%
7/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Asthenia
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Fatigue
|
25.5%
12/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Gait disturbance
|
12.8%
6/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Mucosal inflammation
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Non-cardiac chest pain
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Oedema peripheral
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
General disorders
Pyrexia
|
19.1%
9/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
26.3%
5/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Cellulitis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Clostridium difficile infection
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Influenza
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Oral candidiasis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Pneumonia
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Infections and infestations
Urinary tract infection
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Fall
|
19.1%
9/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
15.8%
3/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Alanine aminotransferase increased
|
21.3%
10/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
7/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Blood creatinine increased
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Lipase increased
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Lymphocyte count decreased
|
12.8%
6/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Neutrophil count decreased
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Platelet count decreased
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
Weight decreased
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Investigations
White blood cell count decreased
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.8%
6/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.9%
7/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
21.1%
4/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Aphasia
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Ataxia
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Dizziness
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Facial paresis
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Headache
|
25.5%
12/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Hemiparesis
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Paraesthesia
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Seizure
|
12.8%
6/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Nervous system disorders
Somnolence
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Agitation
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Anxiety
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Confusional state
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Depression
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Psychiatric disorders
Insomnia
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
10.6%
5/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
0.00%
0/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.4%
3/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.9%
7/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
4/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
10.5%
2/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.1%
1/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
15.8%
3/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/47 • From first dose to 100 days post last dose (up to approximately 48 months)
|
5.3%
1/19 • From first dose to 100 days post last dose (up to approximately 48 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER