Trial Outcomes & Findings for A Trial Evaluating Efficacy & Safety of RVD +/- Panobinostat in Transplant Eligible, Newly Diagnosed Multiple Myeloma (NDMM) (NCT NCT02720510)
NCT ID: NCT02720510
Last Updated: 2018-07-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
84 days
Results posted on
2018-07-24
Participant Flow
A total of 6 patients were randomized and treated in the study. None of the patient completed the study and all patients were discontinued.
Participant milestones
| Measure |
Arm 1 - RVD + Pan
Revlimid, Velcade, dexamethasone and Farydak
|
Arm 2 - RVD
Revlimid, Velcade and Dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Arm 1 - RVD + Pan
Revlimid, Velcade, dexamethasone and Farydak
|
Arm 2 - RVD
Revlimid, Velcade and Dexamethasone
|
|---|---|---|
|
Overall Study
Study Terminated by the sponsor
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
Baseline Characteristics
Full analysis set
Baseline characteristics by cohort
| Measure |
Arm 1 - RVD + Pan
n=3 Participants
Revlimid, Velcade, dexamethasone and Farydak
|
Arm 2 - RVD
n=3 Participants
Revlimid, Velcade and Dexamethasone
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Full analysis set
|
0 Participants
n=7 Participants • Full analysis set
|
0 Participants
n=5 Participants • Full analysis set
|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 3.51 • n=7 Participants
|
60.5 Years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Full analysis set
|
0 Participants
n=7 Participants • Full analysis set
|
0 Participants
n=5 Participants • Full analysis set
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Full analysis set
|
0 Participants
n=7 Participants • Full analysis set
|
0 Participants
n=5 Participants • Full analysis set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Full analysis set
|
0 Participants
n=7 Participants • Full analysis set
|
0 Participants
n=5 Participants • Full analysis set
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • Full analysis set
|
2 Participants
n=7 Participants • Full analysis set
|
3 Participants
n=5 Participants • Full analysis set
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants • Full analysis set
|
1 Participants
n=7 Participants • Full analysis set
|
3 Participants
n=5 Participants • Full analysis set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Full analysis set
|
0 Participants
n=7 Participants • Full analysis set
|
0 Participants
n=5 Participants • Full analysis set
|
PRIMARY outcome
Timeframe: 84 daysPopulation: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3Population: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
MRD negativity by Clonal Sequencing (ClonoSEQTM) assay (Adaptive Biotechnologies)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3 up to end of study, approximately 3 years.Population: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
ORR (CR + PR) and MRD negativity after ASCT and maintenance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 22 up to end of study, approximately 3 yearsPopulation: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
Rate of Very Good Partial Response (VGPR), Complete Response (CR) and Stringent Complete Response (sCR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From measurable response to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.Population: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after the last patient is enrolled to the studyPopulation: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated..
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years after the last patient is enrolled to the studyPopulation: The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1- RVD+PAN
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2 - RVD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1- RVD+PAN
n=3 participants at risk
Revlimid, Velcade, dexamethasone and Farydak
|
Arm 2 - RVD
n=3 participants at risk
Revlimid, Velcade and Dexamethasone
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
Other adverse events
| Measure |
Arm 1- RVD+PAN
n=3 participants at risk
Revlimid, Velcade, dexamethasone and Farydak
|
Arm 2 - RVD
n=3 participants at risk
Revlimid, Velcade and Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Alanine aminotransferase decreased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Transaminases increased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
0.00%
0/3 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER