Trial Outcomes & Findings for Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients (NCT NCT02159365)
NCT ID: NCT02159365
Last Updated: 2019-07-16
Results Overview
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
From Day 1 to End of cycle 2 treatment (approximately 56 days)
Results posted on
2019-07-16
Participant Flow
84 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 10 no longer met study criteria, 1 withdrew consent, and 3 due to other reasons.
Participant milestones
| Measure |
E-Ld
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
E-Ld
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Overall Study
Disease Progression
|
23
|
|
Overall Study
Other reasons
|
11
|
|
Overall Study
Administrative reason by Sponsor
|
9
|
|
Overall Study
Adverse Event unrelated to study drug
|
9
|
|
Overall Study
Study drug toxicity
|
7
|
|
Overall Study
Maximum clinical benefit
|
3
|
|
Overall Study
Subject request to discontinue treatment
|
3
|
|
Overall Study
Subject withdrew consent
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
E-Ld
n=70 Participants
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.40 • n=39 Participants
|
|
Age, Customized
< 75 years
|
49 Participants
n=39 Participants
|
|
Age, Customized
>= 75 years
|
21 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=39 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
34 Participants
n=39 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
32 Participants
n=39 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to End of cycle 2 treatment (approximately 56 days)Population: All Treated Participants
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Outcome measures
| Measure |
E-Ld
n=70 Participants
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
|
0 Participants
Interval 0.0 to 5.1
|
SECONDARY outcome
Timeframe: Date of first dose up to 60 days post last dose (approximately 4 years)Population: All treated participants
An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Outcome measures
| Measure |
E-Ld
n=70 Participants
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
# of participants with any grade infusion reaction
|
3 Participants
|
|
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
# of participants with G3/4 infusion reaction
|
1 Participants
|
Adverse Events
E-Ld
Serious events: 35 serious events
Other events: 68 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
E-Ld
n=70 participants at risk
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Eye disorders
Visual impairment
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Asthenia
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Pyrexia
|
4.3%
3/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Bronchitis
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Cavernous sinus thrombosis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Clostridium difficile infection
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Pneumonia
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Septic shock
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Urosepsis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Acidosis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Spinal cord compression
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Psychiatric disorders
Acute psychosis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Psychiatric disorders
Delirium
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.9%
2/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
Other adverse events
| Measure |
E-Ld
n=70 participants at risk
E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.9%
16/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.6%
13/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Cardiac disorders
Atrial fibrillation
|
8.6%
6/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Eye disorders
Dry eye
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Eye disorders
Vision blurred
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
10/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Constipation
|
28.6%
20/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Diarrhoea
|
37.1%
26/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.9%
9/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Nausea
|
27.1%
19/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Asthenia
|
17.1%
12/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Chills
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Fatigue
|
54.3%
38/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Influenza like illness
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Malaise
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Non-cardiac chest pain
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Oedema peripheral
|
24.3%
17/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Pain
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
General disorders
Pyrexia
|
21.4%
15/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Influenza
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
10/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Pneumonia
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Sinusitis
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Upper respiratory tract infection
|
34.3%
24/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Infections and infestations
Urinary tract infection
|
24.3%
17/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Injury, poisoning and procedural complications
Fall
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Investigations
Blood creatinine increased
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Investigations
Vitamin d decreased
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Investigations
Weight decreased
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
10/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
9/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.7%
11/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
15/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.3%
17/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
20/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.4%
8/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Balance disorder
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Dizziness
|
18.6%
13/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Dysgeusia
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Headache
|
18.6%
13/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Neuropathy peripheral
|
15.7%
11/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Syncope
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Nervous system disorders
Tremor
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Psychiatric disorders
Anxiety
|
15.7%
11/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Psychiatric disorders
Insomnia
|
31.4%
22/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Renal and urinary disorders
Dysuria
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Renal and urinary disorders
Haematuria
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
15/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.6%
6/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.9%
16/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
6/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.9%
9/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
7/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
14/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
13/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Vascular disorders
Hot flush
|
7.1%
5/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Vascular disorders
Hypertension
|
5.7%
4/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
|
Vascular disorders
Hypotension
|
8.6%
6/70 • From Day 1 up to 60 days post last dose of study drug (approximately 4 years assessed up to July 2018)
|
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