Trial Outcomes & Findings for Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma (NCT NCT01559935)
NCT ID: NCT01559935
Last Updated: 2025-09-08
Results Overview
The best response for all patients who had at least one dose of drug was measured. Response categories: Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD). The response is evaluated based on the IMWG criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
From baseline to best response, up to 116 weeks.
Results posted on
2025-09-08
Participant Flow
Two subjects were ineligible and therefore never started treatment.
Participant milestones
| Measure |
Car-BiRD Therapy
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Car Phase
STARTED
|
72
|
|
Car Phase
COMPLETED
|
58
|
|
Car Phase
NOT COMPLETED
|
14
|
|
BiRD Phase
STARTED
|
58
|
|
BiRD Phase
COMPLETED
|
54
|
|
BiRD Phase
NOT COMPLETED
|
4
|
|
Maintenance Phase
STARTED
|
54
|
|
Maintenance Phase
COMPLETED
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Car-BiRD Therapy
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Car Phase
Toxicity
|
4
|
|
Car Phase
Death
|
1
|
|
Car Phase
Lack of Efficacy
|
2
|
|
Car Phase
Lost to Follow-up
|
1
|
|
Car Phase
Physician Decision
|
1
|
|
Car Phase
Withdrawal by Subject
|
2
|
|
Car Phase
Per protocol
|
1
|
|
Car Phase
Insurance
|
1
|
|
Car Phase
non-compliance
|
1
|
|
BiRD Phase
Toxicity
|
1
|
|
BiRD Phase
Lack of Efficacy
|
1
|
|
BiRD Phase
Withdrawal by Subject
|
2
|
|
Maintenance Phase
Remains on study
|
28
|
|
Maintenance Phase
Toxicity
|
1
|
|
Maintenance Phase
Lack of Efficacy
|
18
|
|
Maintenance Phase
Withdrawal by Subject
|
5
|
|
Maintenance Phase
Non-compliance
|
2
|
Baseline Characteristics
72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Baseline characteristics by cohort
| Measure |
Car-BiRD Therapy
n=72 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Age, Customized
Car Phase
|
60.4 years
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Age, Customized
BiRD Phase
|
59.6 years
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Age, Customized
Maintenance Phase
|
59.2 years
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
Car Phase · Female
|
29 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
Car Phase · Male
|
43 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
BiRD Phase · Female
|
26 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
BiRD Phase · Male
|
32 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
Maintenance Phase · Female
|
23 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Sex: Female, Male
Maintenance Phase · Male
|
31 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Car Phase · Hispanic or Latino
|
3 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Car Phase · Not Hispanic or Latino
|
61 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Car Phase · Unknown or Not Reported
|
8 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
BiRD Phase · Hispanic or Latino
|
3 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
BiRD Phase · Not Hispanic or Latino
|
48 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
BiRD Phase · Unknown or Not Reported
|
7 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Hispanic or Latino
|
2 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Not Hispanic or Latino
|
45 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Unknown or Not Reported
|
7 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · American Indian or Alaska Native
|
0 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · Asian
|
0 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · Black or African American
|
5 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · White
|
29 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · More than one race
|
6 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Car Phase · Unknown or Not Reported
|
32 Participants
n=72 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · American Indian or Alaska Native
|
0 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · Asian
|
0 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · Black or African American
|
4 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · White
|
22 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · More than one race
|
5 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
BiRD Phase · Unknown or Not Reported
|
27 Participants
n=58 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · American Indian or Alaska Native
|
0 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · Asian
|
0 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · Black or African American
|
3 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · White
|
20 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · More than one race
|
5 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
|
Race (NIH/OMB)
Maintenance Phase · Unknown or Not Reported
|
26 Participants
n=54 Participants • 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
|
PRIMARY outcome
Timeframe: From baseline to best response, up to 116 weeks.The best response for all patients who had at least one dose of drug was measured. Response categories: Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD). The response is evaluated based on the IMWG criteria.
Outcome measures
| Measure |
Car-BiRD Therapy
n=72 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Response to Car-BiRD Treatment.
sCR/CR
|
28 Participants
|
|
Response to Car-BiRD Treatment.
VGPR
|
31 Participants
|
|
Response to Car-BiRD Treatment.
PR
|
11 Participants
|
|
Response to Car-BiRD Treatment.
SD
|
1 Participants
|
|
Response to Car-BiRD Treatment.
PD
|
0 Participants
|
|
Response to Car-BiRD Treatment.
Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.Population: 44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.
an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.
Outcome measures
| Measure |
Car-BiRD Therapy
n=44 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Event Free Survival
|
401.5 Days
Interval 18.0 to 1222.0
|
SECONDARY outcome
Timeframe: From start of study up to Revlimid Maintenance Cycle 4.Population: 28 participants achieved CR or sCR.
Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on. MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy. MRD positivity is defined as the presence of residual plasma cells (\<5%) on bone marrow biopsy. The IMWG criteria were used to determine CR and sCR.
Outcome measures
| Measure |
Car-BiRD Therapy
n=28 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
MRD Negativity Following CarBiRD Regimen
MRD positive
|
10 Participants
|
|
MRD Negativity Following CarBiRD Regimen
MRD negative
|
17 Participants
|
|
MRD Negativity Following CarBiRD Regimen
Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study drug until first incidence of progression, up to 1222 days.Population: 21 participants had an incidence of progression.
Progression was defined using the IMWG criteria.
Outcome measures
| Measure |
Car-BiRD Therapy
n=21 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Progression Free Survival
|
18.3 months
Interval 2.3 to 40.7
|
SECONDARY outcome
Timeframe: At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.Population: 58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.
At the end of the Car Phase, all participants underwent stem cell collection.
Outcome measures
| Measure |
Car-BiRD Therapy
n=52 Participants
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Stem Cells Collection
|
12854635 Number of stem cells collected per Kg
Standard Deviation 5388946.9
|
Adverse Events
Car-BiRD Therapy
Serious events: 26 serious events
Other events: 72 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Car-BiRD Therapy
n=72 participants at risk
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.8%
2/72 • Number of events 2
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
fever
|
2.8%
2/72 • Number of events 3
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
abnominal infection
|
1.4%
1/72 • Number of events 2
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
lung infection
|
7.4%
4/54 • Number of events 4
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
URI
|
2.8%
2/72 • Number of events 2
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
UTI
|
2.8%
2/72 • Number of events 2
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
femur fracture
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
spinal fracture
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
atrial fibrilation
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
massive heart attack
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
syncope
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Injury, poisoning and procedural complications
fall
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Surgical and medical procedures
surgical procedure
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
increased creatinine
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
dehydration
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
confusion
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer
|
1.4%
1/72 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
non-cardiac chest pain
|
5.6%
3/54 • Number of events 3
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
abdominal pain (small intestinal obstruction)
|
1.7%
1/58 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
acute coronary syndrome
|
1.7%
1/58 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
thromboembolic event
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
diarrhea
|
1.9%
1/54 • Number of events 2
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
acute kidney infection
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
enterocolitis infection
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
cardiac chest pain
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
spinal cord compression
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
creatinine increase
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
secondary malignancy
|
1.9%
1/54 • Number of events 1
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
Other adverse events
| Measure |
Car-BiRD Therapy
n=72 participants at risk
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]
Car Phase:
carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
BiRD Phase:
Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
Maintenance Phase:
Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
72.2%
52/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Blood and lymphatic system disorders
neutropenia
|
33.3%
18/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Blood and lymphatic system disorders
leukopenia
|
20.4%
11/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Blood and lymphatic system disorders
lymphopenia
|
8.6%
5/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
dyspepsia
|
24.1%
13/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
constipation
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
nausea
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
anorexia
|
6.9%
4/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
diarhhea
|
37.0%
20/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
vomiting
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
flatulance
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyponatremia
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
87.5%
63/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
27.8%
20/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypokalemia
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
24.1%
13/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
13.9%
10/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
14.8%
8/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyperuricemia
|
6.9%
5/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hyperhidrosis
|
11.1%
8/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
elevated ALT
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
elevated AST
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
elevated alkaline phosphatase
|
47.2%
34/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
increased creatinine
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
insomnia
|
8.6%
5/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
fatigue
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
chills
|
5.6%
4/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
peripheral neuropathy
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
tremor
|
19.0%
11/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
anxiety/stress
|
18.1%
13/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Psychiatric disorders
depression
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
dizziness / lightheaded
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
paresthesias
|
5.6%
4/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
forgetful
|
5.6%
4/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
dysgeusia
|
29.3%
17/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
headache
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
irritability
|
12.1%
7/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
agitation
|
5.6%
4/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
concentration impairment
|
9.7%
7/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
edema
|
25.9%
14/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
hypertension
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
fever
|
19.4%
14/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms/cramps
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
8.3%
6/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
pain in legs
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
18.5%
10/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
14.8%
8/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
lower extremity pain
|
11.1%
6/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Skin and subcutaneous tissue disorders
rash
|
18.5%
10/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
high BNP
|
13.9%
10/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Renal and urinary disorders
low eGFR
|
6.9%
4/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Renal and urinary disorders
genitourinary frequency
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.3%
11/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
24.1%
13/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
16.7%
9/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
URI
|
40.7%
22/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
UTI
|
6.9%
5/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
Skin Infection
|
5.6%
4/72
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Gastrointestinal disorders
dry mouth
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
ALK increase
|
10.3%
6/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
malaise
|
5.2%
3/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Nervous system disorders
parethesias
|
6.9%
4/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Vascular disorders
cushingoid appearance
|
5.2%
3/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
5.2%
3/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
5.2%
3/58
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypercalcemia
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Metabolism and nutrition disorders
hypernatremia
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
gait disturbance
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
General disorders
hair loss
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Psychiatric disorders
anxiety/stress
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
rib pain
|
11.1%
6/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
chest pain (muscular)
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
arthralgias
|
20.4%
11/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
pain in foot
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Musculoskeletal and connective tissue disorders
upper extremity pain
|
11.1%
6/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Skin and subcutaneous tissue disorders
skin darknening
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Eye disorders
blurry vision
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Cardiac disorders
bradycardia
|
9.3%
5/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
13.0%
7/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
skin Infection
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Infections and infestations
ear infection
|
5.6%
3/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
|
Injury, poisoning and procedural complications
fall
|
7.4%
4/54
Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place