Trial Outcomes & Findings for Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma (NCT NCT02758717)
NCT ID: NCT02758717
Last Updated: 2025-09-09
Results Overview
The primary endpoint of this trial is the rate (percentage) of overall metabolic response. A metabolic response is defined as a participant who has achieved an objective status of Partial metabolic response (PMR) or Complete metabolic response (CMR) at the end of cycle 8. Response is based on PET/CT based on the revised 2014 Lugano Classification. (PMR: Score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size CMR: Score 1 (no uptake above background), 2 (uptake\<=mediastinum), or 3 (uptake \> mediastinum but \<= liver) with or without a residual mass on PET Deauville 5-Point-Scale. The scale ranges from 1 to 5, where 1 is best and 5 is the worst.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to 8 cycles of treatment (approximately 29 weeks)
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
71.5 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
ECOG Performance Status
0
|
14 Participants
n=39 Participants
|
|
ECOG Performance Status
1
|
26 Participants
n=39 Participants
|
|
ECOG Performance Status
2
|
6 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 8 cycles of treatment (approximately 29 weeks)The primary endpoint of this trial is the rate (percentage) of overall metabolic response. A metabolic response is defined as a participant who has achieved an objective status of Partial metabolic response (PMR) or Complete metabolic response (CMR) at the end of cycle 8. Response is based on PET/CT based on the revised 2014 Lugano Classification. (PMR: Score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size CMR: Score 1 (no uptake above background), 2 (uptake\<=mediastinum), or 3 (uptake \> mediastinum but \<= liver) with or without a residual mass on PET Deauville 5-Point-Scale. The scale ranges from 1 to 5, where 1 is best and 5 is the worst.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Metabolic Response Rate
|
60.9 percentage of participants
Interval 45.4 to 74.9
|
SECONDARY outcome
Timeframe: Up to end of course 8The number of participants with an overall response of Complete metabolic response. Response is based on PET/CT based on the revised 2014 Lugano Classification. (CMR: Score 1 (no uptake above background), 2 (uptake\<=mediastinum), or 3 (uptake \> mediastinum but \<= liver) with or without a residual mass on PET Deauville 5-Point-Scale. The scale ranges from 1 to 5, where 1 is best and 5 is the worst.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With an Overall Response of Complete Metabolic Response
|
22 Participants
|
SECONDARY outcome
Timeframe: 30 monthsDOR is time from the date at which the patient's objective status is first noted to be a CMR or PMR to the earliest date progression (progressive metabolic disease \[PMD\] or progressive disease \[PD\]) is documented. Response is based on PET/CT based on the revised 2014 Lugano Classification. (PMR: Score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) CMR: Score 1 (no uptake above background), 2 (uptake\<=mediastinum), or 3 (uptake \> mediastinum but \<= liver) with or without a residual mass on PET Deauville 5-Point-Scale. The scale ranges from 1 to 5, where 1 is best and 5 is the worst. PMD: Score 4 or 5 with an increase in intensity of uptake from baseline and/or New FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment PD: An individual node/lesion must be abnormal with: LDi \> 1.5 cm and Increase by ≥ 50% from PPD nadir and, An increase in LDi or SDi from nadir, 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions \> 2 cm)
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 11.1 to
Median and upper limit duration of response were not estimatable due to a lack of events. Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 30 monthsProgression-free survival is defined as the time from registration to the earliest date of documentation of disease progression (Progressive metabolic disease (PMD) or Progressive disease (PD)) or death due to any cause. Response is based on PET/CT based on the revised 2014 Lugano Classification. (PMD: Score 4 or 5 with an increase in intensity of uptake from baseline and/or New FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment PD: An individual node/lesion must be abnormal with: LDi \> 1.5 cm and Increase by ≥ 50% from PPD nadir and, An increase in LDi or SDi from nadir, 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions \> 2 cm)
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
18.3 months
Interval 12.7 to
The upper limit of the confidence interval was not reached due to a lack of events. Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 30 monthsThe distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
NA months
Median overall survival time was not estimatable due to the low number of patient deaths
|
SECONDARY outcome
Timeframe: Up to 8 cycles of treatment (approximately 29 weeks)Number of participants experiencing at least one toxicity. Toxicity is defined as an adverse event graded 3 or higher by Common Terminology Criteria for Adverse Events version 4.0 deemed at least possibly related to treatment.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 Participants
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Experiencing at Least One Adverse Events Graded 3 or Higher Deemed at Least Possibly Related to Treatment
|
30 Participants
|
Adverse Events
Treatment (Brentuximab Vedotin, Nivolumab)
Serious events: 21 serious events
Other events: 46 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 participants at risk
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/46 • Number of events 3 • 30 months
|
|
Gastrointestinal disorders
Colitis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
General disorders
Death NOS
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
General disorders
Fever
|
8.7%
4/46 • Number of events 4 • 30 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Infections and infestations
Lung infection
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
Creatinine increased
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
Lipase increased
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Investigations
Platelet count decreased
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
Serum amylase increased
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Investigations
Weight loss
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
White blood cell decreased
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Nervous system disorders
Syncope
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Hallucinations
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Vascular disorders
Superior vena cava syndrome
|
2.2%
1/46 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
Treatment (Brentuximab Vedotin, Nivolumab)
n=46 participants at risk
Patients receive 1.8 mg/kg (cap at 180 mg) in 100 to 250 mL NS to final concentration 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin IV over 30 minutes and 3 mg/kg in 100 cc NS nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.7%
4/46 • Number of events 6 • 30 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Cardiac disorders
Heart failure
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
4/46 • Number of events 9 • 30 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Constipation
|
8.7%
4/46 • Number of events 8 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
5/46 • Number of events 5 • 30 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/46 • Number of events 4 • 30 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
2/46 • Number of events 5 • 30 months
|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • Number of events 10 • 30 months
|
|
Gastrointestinal disorders
Rectal fistula
|
2.2%
1/46 • Number of events 2 • 30 months
|
|
General disorders
Fatigue
|
32.6%
15/46 • Number of events 34 • 30 months
|
|
General disorders
Fever
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
General disorders
Pain
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.5%
3/46 • Number of events 4 • 30 months
|
|
Infections and infestations
Papulopustular rash
|
2.2%
1/46 • Number of events 3 • 30 months
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Sinusitis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Infections and infestations
Urinary tract infection
|
6.5%
3/46 • Number of events 6 • 30 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.9%
5/46 • Number of events 8 • 30 months
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
4/46 • Number of events 9 • 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
3/46 • Number of events 8 • 30 months
|
|
Investigations
Creatinine increased
|
26.1%
12/46 • Number of events 35 • 30 months
|
|
Investigations
Ejection fraction decreased
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
GGT increased
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
INR increased
|
4.3%
2/46 • Number of events 4 • 30 months
|
|
Investigations
Investigations - Other, specify
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Investigations
Lipase increased
|
13.0%
6/46 • Number of events 16 • 30 months
|
|
Investigations
Lymphocyte count decreased
|
10.9%
5/46 • Number of events 24 • 30 months
|
|
Investigations
Neutrophil count decreased
|
41.3%
19/46 • Number of events 57 • 30 months
|
|
Investigations
Platelet count decreased
|
32.6%
15/46 • Number of events 61 • 30 months
|
|
Investigations
Serum amylase increased
|
13.0%
6/46 • Number of events 10 • 30 months
|
|
Investigations
Weight gain
|
2.2%
1/46 • Number of events 2 • 30 months
|
|
Investigations
Weight loss
|
4.3%
2/46 • Number of events 8 • 30 months
|
|
Investigations
White blood cell decreased
|
52.2%
24/46 • Number of events 76 • 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
2/46 • Number of events 7 • 30 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.2%
1/46 • Number of events 8 • 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.0%
6/46 • Number of events 22 • 30 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
3/46 • Number of events 6 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
1/46 • Number of events 2 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/46 • Number of events 4 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
2/46 • Number of events 6 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
4/46 • Number of events 5 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Nervous system disorders
Memory impairment
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
37.0%
17/46 • Number of events 96 • 30 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.1%
12/46 • Number of events 40 • 30 months
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Psychosis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.8%
16/46 • Number of events 62 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
3/46 • Number of events 17 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/46 • Number of events 4 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.2%
7/46 • Number of events 19 • 30 months
|
|
Vascular disorders
Hot flashes
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Vascular disorders
Hypertension
|
21.7%
10/46 • Number of events 33 • 30 months
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • 30 months
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/46 • Number of events 1 • 30 months
|
Additional Information
Bruce D. Cheson, M.D.
Lombardi Comprehensive Cancer Center
Phone: 507-266-0800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place