Trial Outcomes & Findings for Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM) (NCT NCT01651039)
NCT ID: NCT01651039
Last Updated: 2018-04-09
Results Overview
The primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
up to 4 years
Results posted on
2018-04-09
Participant Flow
Recruitment began in July 2012 with enrollment from Sept 2012 to August 2015. 41 subjects signed consent (7 screened failed, 32 received study treatment, 5 non-evaluables). 27 out of the 32 subjects are evaluable.
Participant milestones
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.
Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.
Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
|
|---|---|
|
Overall Study
Non-evaluables
|
5
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progressive Disease
|
22
|
Baseline Characteristics
Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)
Baseline characteristics by cohort
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=27 Participants
All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.
Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Age >65 years
|
14 Participants
n=5 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance
0
|
16 Participants
n=5 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance
1
|
11 Participants
n=5 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance
2
|
0 Participants
n=5 Participants
|
|
ISS Staging
Stage 1
|
5 Participants
n=5 Participants
|
|
ISS Staging
Stage 2
|
5 Participants
n=5 Participants
|
|
ISS Staging
Stage 3
|
5 Participants
n=5 Participants
|
|
ISS Staging
missing
|
12 Participants
n=5 Participants
|
|
Immunoglobulin subtype
IgG
|
14 Participants
n=5 Participants
|
|
Immunoglobulin subtype
IgA
|
8 Participants
n=5 Participants
|
|
Immunoglobulin subtype
IgM
|
1 Participants
n=5 Participants
|
|
Immunoglobulin subtype
None
|
4 Participants
n=5 Participants
|
|
FISH
Normal
|
2 Participants
n=5 Participants
|
|
FISH
Any abnormality
|
22 Participants
n=5 Participants
|
|
FISH
Any high risk abnormality
|
17 Participants
n=5 Participants
|
|
FISH
del(17p)
|
5 Participants
n=5 Participants
|
|
FISH
chr1 amplification
|
12 Participants
n=5 Participants
|
|
FISH
t(4;14)
|
4 Participants
n=5 Participants
|
|
FISH
del(13q)
|
5 Participants
n=5 Participants
|
|
FISH
t(11;14)
|
5 Participants
n=5 Participants
|
|
Median time since diagnosis
|
4 years
n=5 Participants
|
|
Prior regimens
|
3 years
n=5 Participants
|
|
Prior therapy
|
3 regimens
n=5 Participants
|
|
Prior Therapy, Exposed
Dexamethasone
|
27 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Thalidomide
|
6 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Lenalidomide
|
27 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Pomalidomide
|
10 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Bortezomib
|
27 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Carfilzomib
|
8 Participants
n=5 Participants
|
|
Prior Therapy, Exposed
Autologous stem cell transplant
|
20 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Dexamethasone
|
19 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Thalidomide
|
2 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Lenalidomide
|
22 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Pomalidomide
|
19 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Bortezomib
|
14 Participants
n=5 Participants
|
|
Prior therapy, Refractory
Carfilzomib
|
7 Participants
n=5 Participants
|
|
Median cumulative duration of prior lenalidomide (len) months
|
13 months
n=5 Participants
|
|
Prior len regimens
|
1 regimens
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
25
|
7 Participants
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
15
|
5 Participants
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
10
|
7 Participants
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
5
|
1 Participants
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
unknown
|
2 Participants
n=5 Participants
|
|
Doses of lenalidomide at time of PD on len
Not Len Refractory Patients
|
5 Participants
n=5 Participants
|
|
Progressed while on last len regimen
|
22 Participants
n=5 Participants
|
|
Len in most recent prior regimen
|
13 Participants
n=5 Participants
|
|
Pom in most recent prior regimen
|
3 Participants
n=5 Participants
|
|
Dex in most recent prior regimen
|
21 Participants
n=5 Participants
|
|
Dex in last len-containing regimen
|
23 Participants
n=5 Participants
|
|
Best response at last treatment
Complete response
|
2 Participants
n=5 Participants
|
|
Best response at last treatment
Very Good Partial Response
|
4 Participants
n=5 Participants
|
|
Best response at last treatment
Partial Response
|
5 Participants
n=5 Participants
|
|
Best response at last treatment
Minimal Response
|
9 Participants
n=5 Participants
|
|
Best response at last treatment
Stable Disease
|
6 Participants
n=5 Participants
|
|
Best response at last treatment
Progressive disease
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 yearsThe primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=27 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
The Best Overall Response Rate (ORR)
|
11 Participants
|
PRIMARY outcome
Timeframe: up to 4 yearsPopulation: Only Len Refractory Patients
The primary endpoint will be the best overall response rate (ORR)
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=22 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Overall Response Rate for Len Refractory Patients
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsResponse Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003). CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to \<200 mg per 24 h MR-≥ 25% but \< 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25-49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions. SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=27 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Response Rates
Complete Response (CR)
|
2 Participants
|
|
Response Rates
Very Good Partial Response (VGPR)
|
4 Participants
|
|
Response Rates
Partial Response (PR)
|
5 Participants
|
|
Response Rates
Minimal Response (MR)
|
9 Participants
|
|
Response Rates
Stable Disease (SD)
|
6 Participants
|
|
Response Rates
Progressive Disease (PD)
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsResponse Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003). CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to \<200 mg per 24 h MR-≥ 25% but \< 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25-49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions. SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=22 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Response Rates for Len Refractory Patients
Complete Response
|
1 Participants
|
|
Response Rates for Len Refractory Patients
Very Good Partial Response
|
4 Participants
|
|
Response Rates for Len Refractory Patients
Partial Response
|
3 Participants
|
|
Response Rates for Len Refractory Patients
Minimal Response
|
7 Participants
|
|
Response Rates for Len Refractory Patients
Stable Disease
|
6 Participants
|
|
Response Rates for Len Refractory Patients
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsThe number of response rates in participants that have achieved MR, PR, VGPR, CR
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=27 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Clinical Benefit Rate
|
20 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Only Len Refractory Patients
The number of response rates in Lens Refractory participants that have achieved MR, PR, VGPR, CR
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=22 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Clinical Benefit Rate for Len Refractory Patients
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsThe number of response rates participants with SD, MR, PR, VGPR, or CR
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=27 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Disease Control Rate
|
26 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsThe number of response rates in Len refractory participants with SD, MR, PR, VGPR, or CR
Outcome measures
| Measure |
Panobinostat, Lenalidomide and Dexamethasone
n=22 Participants
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
|
|---|---|
|
Disease Control Rate for Lens Refractory Rate
|
21 Participants
|
Adverse Events
All Subjects
Serious events: 14 serious events
Other events: 38 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Subjects
n=41 participants at risk
Adverse events collected for all subjects who signed consent.
|
|---|---|
|
Cardiac disorders
Cardiac Catherization
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Chest Pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Ehrlichiosis Babesiosis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Failure to thrive
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Hypotension
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Surgical and medical procedures
Lap low Anterior Surgery
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Shortness of breath
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
Other adverse events
| Measure |
All Subjects
n=41 participants at risk
Adverse events collected for all subjects who signed consent.
|
|---|---|
|
Metabolism and nutrition disorders
hypokalemia
|
17.1%
7/41 • Number of events 9
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hypomagnesia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hyponatremia
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.2%
5/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hypophosphorous
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Hypotension
|
4.9%
2/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
General disorders
Hypoxia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
increased blood sugar
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
increased creatinine
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
increased gas
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
increased phosphorus
|
2.4%
1/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
increased thirst
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
infection
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
influenza
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
insomnia
|
24.4%
10/41 • Number of events 12
Adverse events collected for all subjects who signed consent
|
|
General disorders
insomnia (post dex)
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
intermittent diarrhea
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
intermittent dry cough
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
intermittent headache
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
intermittent heartburn
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Skin and subcutaneous tissue disorders
intermittent itching
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
jaw pain
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Jitters (with dex)
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
L rib pain
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
L Upper Leg Bone pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
LE edema
|
4.9%
2/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
General disorders
LE weakness
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Left ankle edema
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Left lower extremities deep vein thrombosis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Left sternal pain (intermittent)
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Leg cramps
|
9.8%
4/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
leukocyte count decreased
|
17.1%
7/41 • Number of events 14
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
leukopenia
|
9.8%
4/41 • Number of events 8
Adverse events collected for all subjects who signed consent
|
|
General disorders
localized edema
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
loose stools
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Low magnesium
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
2.4%
1/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Lower extremity edema
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.1%
7/41 • Number of events 25
Adverse events collected for all subjects who signed consent
|
|
General disorders
Malaise
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Mid back bone pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Mid-back Pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Mildly elevated phosphorus
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Minor congestion dry cough
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Mood irritability
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Mood Swings/Confusion
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Mouth sore
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
3/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nasal congestion
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nausea
|
26.8%
11/41 • Number of events 16
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nausea intermittent
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nausea/vomiting
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Neck numbness
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Neck pain
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Neuropathy
|
9.8%
4/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Neutropenia
|
63.4%
26/41 • Number of events 176
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nightsweats
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Nose bleeding
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Eye disorders
Optic nerve damage
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Oral Thrush
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Pain at the base of skull
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Pain on upper extremities
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Paronchytis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Pedal Edema
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Peripheral Neuropathy
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Peripheral Neuropathy Bilateral
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Pneumonia
|
7.3%
3/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Pneumonia (SOB)
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Poor appetite
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Constipation
|
31.7%
13/41 • Number of events 17
Adverse events collected for all subjects who signed consent
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
10/41 • Number of events 16
Adverse events collected for all subjects who signed consent
|
|
Respiratory, thoracic and mediastinal disorders
Cough/cold
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Cramps on both legs
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Hepatobiliary disorders
Creatinine increase
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
decreased appetite
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Dental abscess
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Psychiatric disorders
Depression
|
9.8%
4/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Diarrhea
|
39.0%
16/41 • Number of events 29
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Diarrhea intermittent
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Nervous system disorders
Dizziness
|
17.1%
7/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
Nervous system disorders
Dizziness intermittent
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Cough, dry
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Eye disorders
Dry eyes
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Dry mouth
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
DVT left leg
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
DVT right leg
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Dyspnea on exertion
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Dyspepsia
|
4.9%
2/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
General disorders
Dyspnea
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Renal and urinary disorders
Dysuria
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Edema
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Epistaxis
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Facial swellinig
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Fall
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Fatigue
|
56.1%
23/41 • Number of events 44
Adverse events collected for all subjects who signed consent
|
|
General disorders
Fatigue (post dex)
|
2.4%
1/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
General disorders
Fever
|
17.1%
7/41 • Number of events 14
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Fistula
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Flank/lats discomfort
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Renal and urinary disorders
Foam in urine
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
forehead bumps
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
Fungal rash
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.3%
3/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
GI symptoms
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Gum irritation
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hypocalcemia
|
2.4%
1/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
General disorders
hypoguesia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Hand cramps
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Headache
|
12.2%
5/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
General disorders
Headache, intermittent
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Hematoma
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Renal and urinary disorders
Hematuria
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Hemorrhoid pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Hiccups
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Hoarse voice
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Hoarseness
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
hot flashes
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hypercalcemia
|
7.3%
3/41 • Number of events 6
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hyperglycemia
|
4.9%
2/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hyperkalemia
|
4.9%
2/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
hyperpigmentation of soles
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
hypersalivation
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
hypertension
|
7.3%
3/41 • Number of events 7
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.8%
4/41 • Number of events 4
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Acute GI upset
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Renal and urinary disorders
acute renal insufficiency
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Alanine Aminotransferase
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Allergic rhinitis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
Alk phos elevation
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
ALT elevation
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Metabolism and nutrition disorders
ALT increased
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
General disorders
Altered smell
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Altered taste
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Anemia
|
43.9%
18/41 • Number of events 56
Adverse events collected for all subjects who signed consent
|
|
General disorders
Anorexia
|
17.1%
7/41 • Number of events 8
Adverse events collected for all subjects who signed consent
|
|
General disorders
anorexia intermittent
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Atypical Chest Pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Nervous system disorders
Balance issue
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Bilateral knee pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Bilateral lower extremity cramps
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Vascular disorders
Bilateral lower extremity swelling
|
7.3%
3/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
bilateral submandibular lymph node pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Hepatobiliary disorders
bilirubin increase
|
7.3%
3/41 • Number of events 5
Adverse events collected for all subjects who signed consent
|
|
General disorders
Bleeding gums
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Bloating
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Blood in stool
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Eye disorders
Blurry vision
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
2/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
Bone pain - Right wrist
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Bradycardia
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Bruising
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Blood and lymphatic system disorders
Bruising (right abd)
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Burning would right foot
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Infections and infestations
C. Difficile
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Eye disorders
Cataracts in both eyes
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Musculoskeletal and connective tissue disorders
C3-C4 compression fracture
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Cheek flushing
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Cheek pain
|
2.4%
1/41 • Number of events 2
Adverse events collected for all subjects who signed consent
|
|
Skin and subcutaneous tissue disorders
Cheiilitis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Chest discomfort
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Chest Pain
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Chest Pain Intermittent
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Chest tightness
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Chills
|
7.3%
3/41 • Number of events 3
Adverse events collected for all subjects who signed consent
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Cardiac disorders
Conduction disorder
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
Nervous system disorders
Confusion
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
|
General disorders
Congestion
|
2.4%
1/41 • Number of events 1
Adverse events collected for all subjects who signed consent
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place