Trial Outcomes & Findings for Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140) (NCT NCT02038946)
NCT ID: NCT02038946
Last Updated: 2022-01-04
Results Overview
ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Results posted on
2022-01-04
Participant Flow
116 participants were enrolled; 92 received study treatment. Participants were enrolled but not treated because they no longer met study criteria (n=20), withdrew consent (n=1), or for other reasons (n=3).
Participant milestones
| Measure |
Arm 1: Nivolumab
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Arm 1: Nivolumab
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other reasons
|
2
|
Baseline Characteristics
All treated participants
Baseline characteristics by cohort
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 10.50 • n=5 Participants • All treated participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants • All treated participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants • All treated participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • All treated participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • All treated participants
|
PRIMARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Overall Response Rate (ORR) as Determined by IRRC
|
4.3 Percentage of participants
Interval 1.2 to 10.8
|
SECONDARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, as described in the IWG response criteria
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Duration of Response (DOR) Based on IRRC Assessments
|
10.94 months
Interval 8.31 to 13.57
|
SECONDARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Complete Remission Rate (CRR) Based on IRRC Assessment
|
1.1 Percentage of participants
Interval 0.0 to 5.9
|
SECONDARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Partial Remission (PR) Rate Based on IRRC Assessment
|
3.3 Percentage of participants
Interval 0.7 to 9.2
|
SECONDARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Progression Free Survival (PFS) Based on IRRC Assessment
|
2.20 months
Interval 1.91 to 3.58
|
SECONDARY outcome
Timeframe: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)Population: All treated participants
ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Outcome measures
| Measure |
Arm 1: Nivolumab
n=92 Participants
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Overall Response Rate (ORR) Based on Investigator Assessments
|
10.9 Percentage of participants
Interval 5.3 to 19.1
|
Adverse Events
Nivolumab 3 mg/kg
Serious events: 46 serious events
Other events: 89 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Nivolumab 3 mg/kg
n=92 participants at risk
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Blood and lymphatic system disorders
Cytopenia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
4/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
3/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
3/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Asthenia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Fatigue
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
General physical health deterioration
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Pyrexia
|
6.5%
6/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Immune system disorders
Anaphylactic shock
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Immune system disorders
Hypersensitivity
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Appendicitis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Bacteraemia
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Erysipelas
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Fungal infection
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Herpes zoster
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
3.3%
3/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Pneumonia
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Pulmonary sepsis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Skin infection
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Staphylococcal sepsis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Viral infection
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Investigations
Influenza B virus test positive
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Investigations
Transaminases increased
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.7%
8/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Nervous system disorders
Sciatica
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Nervous system disorders
Syncope
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Psychiatric disorders
Confusional state
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
2/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
1.1%
1/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
Other adverse events
| Measure |
Nivolumab 3 mg/kg
n=92 participants at risk
Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.3%
15/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.9%
10/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
8/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
15/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Constipation
|
15.2%
14/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
23.9%
22/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Dysphagia
|
5.4%
5/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
23/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
12/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Asthenia
|
9.8%
9/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Fatigue
|
25.0%
23/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Oedema peripheral
|
10.9%
10/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
General disorders
Pyrexia
|
27.2%
25/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
8/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Pneumonia
|
6.5%
6/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
11/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Infections and infestations
Urinary tract infection
|
9.8%
9/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.2%
14/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
6/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
6/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
11/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.4%
5/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
6/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Nervous system disorders
Dizziness
|
7.6%
7/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Nervous system disorders
Headache
|
5.4%
5/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.2%
25/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
13/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
5/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
11/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
8/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.4%
5/92 • AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 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