Trial Outcomes & Findings for Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma (NCT NCT01441973)
NCT ID: NCT01441973
Last Updated: 2018-01-23
Results Overview
Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From day of last patient, first dose to 6 months
Results posted on
2018-01-23
Participant Flow
The study enrolled a total of 41 participants, and 31 received treatment. The 10 participants enrolled who did not receive treatment failed to meet the inclusion criteria.
Participant milestones
| Measure |
Elotuzumab, 20 mg/kg
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
| Measure |
Elotuzumab, 20 mg/kg
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
|---|---|---|
|
Overall Study
Disease progression
|
8
|
6
|
|
Overall Study
Adverse event unrelated to study drug
|
3
|
2
|
|
Overall Study
Participant request to discontinue
|
1
|
1
|
|
Overall Study
Poor compliance/noncompliance
|
0
|
1
|
|
Overall Study
Administrative reason by sponsor
|
3
|
5
|
|
Overall Study
Participant withdrew consent
|
0
|
1
|
Baseline Characteristics
Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Baseline characteristics by cohort
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
59.3 Years
STANDARD_DEVIATION 9.37 • n=7 Participants
|
59.2 Years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
65 years and older to younger than 75 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Serum monoclonal (M) protein
|
29.5 g/L
STANDARD_DEVIATION 15.19 • n=5 Participants
|
21.9 g/L
STANDARD_DEVIATION 11.46 • n=7 Participants
|
25.6 g/L
STANDARD_DEVIATION 13.72 • n=5 Participants
|
|
Urine M protein
|
0.208 g/day
STANDARD_DEVIATION 0.6199 • n=5 Participants
|
0.094 g/day
STANDARD_DEVIATION 0.2131 • n=7 Participants
|
0.149 g/day
STANDARD_DEVIATION 0.4532 • n=5 Participants
|
|
Time from diagnosis to enrollment
|
31.75 Months
STANDARD_DEVIATION 37.572 • n=5 Participants
|
36.81 Months
STANDARD_DEVIATION 35.103 • n=7 Participants
|
34.37 Months
STANDARD_DEVIATION 35.798 • n=5 Participants
|
PRIMARY outcome
Timeframe: From day of last patient, first dose to 6 monthsPopulation: All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).
Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=13 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=12 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=31 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
|
-2.562 % chg from BL in M pro/% chg CD56^dim cs
Interval -5.439 to 0.316
|
2.464 % chg from BL in M pro/% chg CD56^dim cs
Interval 0.086 to 4.842
|
0.274 % chg from BL in M pro/% chg CD56^dim cs
Interval -1.722 to 2.27
|
SECONDARY outcome
Timeframe: From day of last patient, first dose to 6 monthsPopulation: All participants who received at least 1 dose of study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=31 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
SAEs
|
8 Participants
|
7 Participants
|
15 Participants
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
AEs leading to discontinuation
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
Infusion reactions
|
4 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 monthsPopulation: All participants who received at least 1 dose of study drug
Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=22 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Lymphocytes
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Hyponatremia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Hyperkalemia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Hyperglycemia
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 monthsPopulation: All participants who received at least 1 dose of study drug
All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=31 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)Population: All treated participants
The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=31 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Progression Free Survival (PFS) Rate
|
0.71 Probability of Progression Free Survival
Interval 0.45 to 0.86
|
0.54 Probability of Progression Free Survival
Interval 0.31 to 0.72
|
0.62 Probability of Progression Free Survival
Interval 0.45 to 0.75
|
SECONDARY outcome
Timeframe: From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)Population: All treated participants
ORR is defined as the number of participants with stringent compete response \[SCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level \<100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to \<200 mg/24 hour
Outcome measures
| Measure |
Elotuzumab, 20 mg/kg
n=15 Participants
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
|
Elotuzumab, 10 mg/kg
n=16 Participants
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
|
Elotuzumab, All Dosages
n=31 Participants
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
13.3 Percentage of participants
Interval 2.4 to 36.3
|
6.3 Percentage of participants
Interval 0.3 to 26.4
|
9.7 Percentage of participants
Interval 2.7 to 23.2
|
Adverse Events
Elotuzumab(E) : 10 mg/kg/Dose
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Elotuzumab(E) : 20 mg/kg/Dose
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Elotuzumab(E) : 10 mg/kg/Dose
n=16 participants at risk
|
Elotuzumab(E) : 20 mg/kg/Dose
n=15 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16
|
6.7%
1/15
|
|
General disorders
Asthenia
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Influenza
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16
|
6.7%
1/15
|
|
Infections and infestations
Rectal abscess
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Urosepsis
|
0.00%
0/16
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/16
|
6.7%
1/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
6.2%
1/16
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
6.2%
1/16
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/16
|
6.7%
1/15
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16
|
0.00%
0/15
|
Other adverse events
| Measure |
Elotuzumab(E) : 10 mg/kg/Dose
n=16 participants at risk
|
Elotuzumab(E) : 20 mg/kg/Dose
n=15 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
5/16
|
13.3%
2/15
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
12.5%
2/16
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
2/16
|
0.00%
0/15
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
2/16
|
6.7%
1/15
|
|
Cardiac disorders
Cardiac failure congestive
|
6.2%
1/16
|
0.00%
0/15
|
|
Cardiac disorders
Coronary artery disease
|
6.2%
1/16
|
0.00%
0/15
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16
|
6.7%
1/15
|
|
Cardiac disorders
Pericardial effusion
|
6.2%
1/16
|
0.00%
0/15
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16
|
6.7%
1/15
|
|
Ear and labyrinth disorders
Cerumen impaction
|
12.5%
2/16
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.2%
1/16
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16
|
6.7%
1/15
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16
|
0.00%
0/15
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/16
|
6.7%
1/15
|
|
Eye disorders
Blepharitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Eye disorders
Cataract
|
6.2%
1/16
|
6.7%
1/15
|
|
Eye disorders
Dry eye
|
6.2%
1/16
|
0.00%
0/15
|
|
Eye disorders
Eye discharge
|
6.2%
1/16
|
0.00%
0/15
|
|
Eye disorders
Eye irritation
|
12.5%
2/16
|
0.00%
0/15
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/16
|
6.7%
1/15
|
|
Eye disorders
Photopsia
|
6.2%
1/16
|
6.7%
1/15
|
|
Eye disorders
Retinal detachment
|
6.2%
1/16
|
0.00%
0/15
|
|
Eye disorders
Retinal disorder
|
6.2%
1/16
|
0.00%
0/15
|
|
Eye disorders
Vision blurred
|
0.00%
0/16
|
6.7%
1/15
|
|
Eye disorders
Vitreous floaters
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
2/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
|
13.3%
2/15
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16
|
26.7%
4/15
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
5/16
|
26.7%
4/15
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16
|
13.3%
2/15
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Large intestine polyp
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16
|
20.0%
3/15
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Oral disorder
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Palatal disorder
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Tongue blistering
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/16
|
13.3%
2/15
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Asthenia
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Catheter site pain
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Chest pain
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Chills
|
12.5%
2/16
|
26.7%
4/15
|
|
General disorders
Chronic fatigue syndrome
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Cyst
|
6.2%
1/16
|
0.00%
0/15
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Fatigue
|
62.5%
10/16
|
53.3%
8/15
|
|
General disorders
Feeling cold
|
12.5%
2/16
|
0.00%
0/15
|
|
General disorders
Feeling jittery
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Influenza like illness
|
6.2%
1/16
|
0.00%
0/15
|
|
General disorders
Malaise
|
6.2%
1/16
|
20.0%
3/15
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16
|
0.00%
0/15
|
|
General disorders
Oedema
|
6.2%
1/16
|
0.00%
0/15
|
|
General disorders
Oedema peripheral
|
25.0%
4/16
|
13.3%
2/15
|
|
General disorders
Pain
|
12.5%
2/16
|
6.7%
1/15
|
|
General disorders
Peripheral swelling
|
6.2%
1/16
|
6.7%
1/15
|
|
General disorders
Pyrexia
|
18.8%
3/16
|
33.3%
5/15
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.2%
1/16
|
0.00%
0/15
|
|
Hepatobiliary disorders
Ocular icterus
|
6.2%
1/16
|
6.7%
1/15
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16
|
6.7%
1/15
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16
|
13.3%
2/15
|
|
Infections and infestations
Appendicitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Candida infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Ear infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Ear infection viral
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Epididymitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Febrile infection
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Fungal infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Gastroenteritis viral
|
12.5%
2/16
|
6.7%
1/15
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Gingivitis
|
12.5%
2/16
|
6.7%
1/15
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16
|
20.0%
3/15
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Influenza
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Lyme disease
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16
|
20.0%
3/15
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16
|
0.00%
0/15
|
|
Infections and infestations
Purulence
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Rhinitis
|
31.2%
5/16
|
13.3%
2/15
|
|
Infections and infestations
Sinusitis
|
18.8%
3/16
|
6.7%
1/15
|
|
Infections and infestations
Sinusitis bacterial
|
6.2%
1/16
|
0.00%
0/15
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Upper respiratory tract infection
|
75.0%
12/16
|
60.0%
9/15
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Viral infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.5%
2/16
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Burns second degree
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
2/16
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.2%
1/16
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Hand fracture
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Laceration
|
6.2%
1/16
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Limb fracture
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
2/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Tendon injury
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Blood calcium increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Blood cholesterol increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Blood potassium increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Cardiac murmur
|
6.2%
1/16
|
6.7%
1/15
|
|
Investigations
Eosinophil count increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Haemoglobin decreased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Heart rate decreased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Neutrophil count increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Protein total increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Protein urine present
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Red blood cell count decreased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Weight decreased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Weight increased
|
6.2%
1/16
|
6.7%
1/15
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
White blood cell count increased
|
0.00%
0/16
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
2/16
|
13.3%
2/15
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
31.2%
5/16
|
13.3%
2/15
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
1/16
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16
|
13.3%
2/15
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
1/16
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.8%
3/16
|
20.0%
3/15
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
1/16
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
6.2%
1/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
6/16
|
40.0%
6/15
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
2/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
56.2%
9/16
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
12.5%
2/16
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.2%
1/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
2/16
|
20.0%
3/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.2%
1/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
4/16
|
26.7%
4/15
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/16
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/16
|
6.7%
1/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
6.2%
1/16
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/16
|
6.7%
1/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.2%
1/16
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16
|
26.7%
4/15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16
|
6.7%
1/15
|
|
Nervous system disorders
Headache
|
43.8%
7/16
|
20.0%
3/15
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16
|
13.3%
2/15
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16
|
13.3%
2/15
|
|
Nervous system disorders
Migraine
|
6.2%
1/16
|
6.7%
1/15
|
|
Nervous system disorders
Muscle tone disorder
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Nerve compression
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16
|
20.0%
3/15
|
|
Nervous system disorders
Paraesthesia
|
25.0%
4/16
|
6.7%
1/15
|
|
Nervous system disorders
Sciatica
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Sinus headache
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16
|
0.00%
0/15
|
|
Nervous system disorders
Syncope
|
0.00%
0/16
|
6.7%
1/15
|
|
Nervous system disorders
Tremor
|
12.5%
2/16
|
0.00%
0/15
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16
|
6.7%
1/15
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16
|
6.7%
1/15
|
|
Psychiatric disorders
Insomnia
|
43.8%
7/16
|
20.0%
3/15
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16
|
6.7%
1/15
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16
|
0.00%
0/15
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16
|
0.00%
0/15
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/16
|
6.7%
1/15
|
|
Renal and urinary disorders
Micturition urgency
|
6.2%
1/16
|
0.00%
0/15
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/16
|
6.7%
1/15
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16
|
0.00%
0/15
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Breast pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/16
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
1/16
|
13.3%
2/15
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16
|
13.3%
2/15
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16
|
13.3%
2/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
31.2%
5/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.8%
3/16
|
20.0%
3/15
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
4/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.2%
1/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
6.2%
1/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.5%
2/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
4/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
1/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/16
|
6.7%
1/15
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/16
|
6.7%
1/15
|
|
Vascular disorders
Flushing
|
6.2%
1/16
|
13.3%
2/15
|
|
Vascular disorders
Haematoma
|
0.00%
0/16
|
6.7%
1/15
|
|
Vascular disorders
Hot flush
|
6.2%
1/16
|
0.00%
0/15
|
|
Vascular disorders
Hypertension
|
6.2%
1/16
|
6.7%
1/15
|
|
Vascular disorders
Hypotension
|
12.5%
2/16
|
6.7%
1/15
|
Additional Information
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