Trial Outcomes & Findings for Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma (NCT NCT00966693)
NCT ID: NCT00966693
Last Updated: 2020-11-04
Results Overview
To determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
77 participants
Primary outcome timeframe
After one 28-day cycle
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
RTD (Cohort 1, Phase 1)
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
49
|
|
Overall Study
Phase 1 Completed
|
2
|
3
|
6
|
0
|
|
Overall Study
Phase 2 Completed
|
0
|
0
|
0
|
46
|
|
Overall Study
COMPLETED
|
2
|
3
|
6
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
23
|
Reasons for withdrawal
| Measure |
RTD (Cohort 1, Phase 1)
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
5
|
|
Overall Study
Disease Progression
|
0
|
0
|
1
|
16
|
Baseline Characteristics
Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
49 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Age >= 18 years old
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
> = 1 line of previous therapy
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Measurable levels of myeloma >=.5M serum-Protein
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Measurable levels of myeloma >=.2 Urine-Protein
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Abnormal Free Light Chain Ratio
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Creatine < 2.5 mg/dL
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Platelets > 50,000
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Total Bilirubin < 2.0
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
AST or ALT < 3x Upper Limit
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Anti-coagulant tolerance (PTT) normal
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Cognitively Aware & Physically Able
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
No Pregnant/Breast Feeding Females
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Females non-procreative sex
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Men non-procreative sex
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
No Cancer Therapy in 21 days
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
No Desquamating Rash regarding Thalidomide
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
Days off prev treatment >= 25
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Relapsed/Refractory Multiple Myeloma
No Known Study Drug Allergies
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: After one 28-day cycleTo determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM).
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Partial Remission
|
2 Participants
|
0 Participants
|
2 Participants
|
13 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Progressive Disease
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Very Good Partial Remission
|
0 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Minimal Residual Disease
|
0 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Stringent Complete Remission
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Non Evaluable
|
1 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
|
Complete Response(CR) and Very Good Partial Response(VGPR)
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 9 yearsTime to Progression was estimated using Kaplan Meier analysis.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Time to Progression
|
32.74 Months
Standard Deviation 27
|
9.04 Months
Standard Deviation 7.49
|
14.61 Months
Standard Deviation 16.41
|
10.02 Months
Standard Deviation 17.61
|
SECONDARY outcome
Timeframe: Up to 9 yearsEstimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Progression Free Survival
|
32.74 Months
Standard Deviation 27
|
9.04 Months
Standard Deviation 7.49
|
14.61 Months
Standard Deviation 16.41
|
10.02 Months
Standard Deviation 17.61
|
SECONDARY outcome
Timeframe: Up to 9 yearsEstimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Time to Best Response
|
19 months
Standard Deviation 1.41
|
5 months
Standard Deviation 6.08
|
5.16 months
Standard Deviation 7.03
|
3.3 months
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Up to 9 yearsPopulation: The Number in each of the arms was insufficient to conduct regression analyses, therefore regression analyses was conducted overall. Participants who were Thalidomide incompatible.
Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=2 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=6 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
0 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsEstimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
RTD (Cohort 1, Phase 1)
n=3 Participants
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 Participants
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 Participants
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Time to Next Therapy
|
52.4 months
Interval 1.94 to
insufficient number of participants with events
|
14.3 months
Interval 5.19 to
insufficient number of participants with events
|
10.5 months
Interval 4.96 to
insufficient number of participants with events
|
6.47 months
Interval 4.14 to
insufficient number of participants with events
|
Adverse Events
RTD (Cohort 1, Phase 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RTD (Cohort 2, Phase 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RTD (Cohort 3, Phase 1)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
RTD (Cohort 2, Phase 2)
Serious events: 7 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RTD (Cohort 1, Phase 1)
n=3 participants at risk
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 participants at risk
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 participants at risk
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 participants at risk
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
General disorders
Death
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
Other adverse events
| Measure |
RTD (Cohort 1, Phase 1)
n=3 participants at risk
Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 1)
n=3 participants at risk
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 3, Phase 1)
n=9 participants at risk
Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
|
RTD (Cohort 2, Phase 2)
n=49 participants at risk
Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Atrial Injury
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Ear and labyrinth disorders
Auditory Ear (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Immune system disorders
Autoimmune Disorder (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
40.8%
20/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hyperbilirubia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
3/9 • Baseline to study completion up to 9 years
|
20.4%
10/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypocarpnia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hyperglycemia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
77.8%
7/9 • Baseline to study completion up to 9 years
|
91.8%
45/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hyperuricemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
36.7%
18/49 • Baseline to study completion up to 9 years
|
|
Investigations
Activated PTT
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
77.8%
7/9 • Baseline to study completion up to 9 years
|
24.5%
12/49 • Baseline to study completion up to 9 years
|
|
Investigations
Acidosis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Investigations
ALT Increase
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
55.6%
5/9 • Baseline to study completion up to 9 years
|
32.7%
16/49 • Baseline to study completion up to 9 years
|
|
Investigations
Alkaline Phosphate increase
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Immune system disorders
Allergy
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Anal Hemmorhage
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
10.2%
5/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
3/9 • Baseline to study completion up to 9 years
|
16.3%
8/49 • Baseline to study completion up to 9 years
|
|
Investigations
AST Increase
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
38.8%
19/49 • Baseline to study completion up to 9 years
|
|
Investigations
Blood Bone Marrow (other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Bone Development Abnormal
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
BonePain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
10.2%
5/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hemmorhage
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Skin and subcutaneous tissue disorders
Brusing
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Cataract
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Cardiac General (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypocaligulopathy
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
67.3%
33/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
General disorders
Constitutional Symptoms
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
34.7%
17/49 • Baseline to study completion up to 9 years
|
|
Investigations
Creatinine increase
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
55.6%
5/9 • Baseline to study completion up to 9 years
|
55.1%
27/49 • Baseline to study completion up to 9 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
General disorders
Dehydration
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
10.2%
5/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Depressed Conciousness Level
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Skin and subcutaneous tissue disorders
Dermatological/Skin (other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
55.6%
5/9 • Baseline to study completion up to 9 years
|
65.3%
32/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
63.3%
31/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Dry Eye Syndrome
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
40.8%
20/49 • Baseline to study completion up to 9 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
77.8%
7/9 • Baseline to study completion up to 9 years
|
77.6%
38/49 • Baseline to study completion up to 9 years
|
|
General disorders
Edema Limbs
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
88.9%
8/9 • Baseline to study completion up to 9 years
|
73.5%
36/49 • Baseline to study completion up to 9 years
|
|
Endocrine disorders
Endocrine (other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Esophogeal Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Eye Muscle Weakness
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Eye Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
100.0%
9/9 • Baseline to study completion up to 9 years
|
100.0%
49/49 • Baseline to study completion up to 9 years
|
|
General disorders
Fever
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
34.7%
17/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Flashing Vision
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
General disorders
Flu-like Symptoms
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Gait Abnormal
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Gastric Infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Gastrointestinal General
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Endocrine disorders
Glucose intolerance
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
General disorders
Headache
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
20.4%
10/49 • Baseline to study completion up to 9 years
|
|
Ear and labyrinth disorders
Hearing Loss
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Investigations
Anemia
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
87.8%
43/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Epstaxis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Hemorrhoidal/hemorrhage
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Hemorrhage Urinary
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Hiccough
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypercalcemia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
20.4%
10/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
10.2%
5/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Hypotension
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
16.3%
8/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
22.4%
11/49 • Baseline to study completion up to 9 years
|
|
Investigations
INR Increase
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
3/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
16.3%
8/49 • Baseline to study completion up to 9 years
|
|
Psychiatric disorders
Irratibility
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Jejunal
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Joint Disorder
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Investigations
Leukopenia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
71.4%
35/49 • Baseline to study completion up to 9 years
|
|
Blood and lymphatic system disorders
Lymphatics (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
General disorders
Localized Edema
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
26.5%
13/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Memory Impairement
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
55.6%
5/9 • Baseline to study completion up to 9 years
|
61.2%
30/49 • Baseline to study completion up to 9 years
|
|
Investigations
Metabolic/Laboratory (Other)
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
88.9%
8/9 • Baseline to study completion up to 9 years
|
59.2%
29/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
49.0%
24/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (Other)
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
24.5%
12/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Myalgia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
38.8%
19/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Mycardial Ichemia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
51.0%
25/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Neurology (Other)
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
20.4%
10/49 • Baseline to study completion up to 9 years
|
|
Investigations
ANC Decrease
|
100.0%
3/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
67.3%
33/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Ocular/Visual (Other)
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporsis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
3/9 • Baseline to study completion up to 9 years
|
61.2%
30/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Pain (Other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Pain in extremity
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
12.2%
6/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
77.8%
7/9 • Baseline to study completion up to 9 years
|
83.7%
41/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Photosensitivity
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Investigations
Thromboctopenia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
66.7%
6/9 • Baseline to study completion up to 9 years
|
61.2%
30/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
26.5%
13/49 • Baseline to study completion up to 9 years
|
|
Investigations
Proteinuria
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Pulmonary (Other)
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
14.3%
7/49 • Baseline to study completion up to 9 years
|
|
Skin and subcutaneous tissue disorders
Rash acneform
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Renal/Genitourinary (Other)
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Retinopathy
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypoalbumenia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
100.0%
9/9 • Baseline to study completion up to 9 years
|
67.3%
33/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypocalcemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
88.9%
8/9 • Baseline to study completion up to 9 years
|
51.0%
25/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypomagnesemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
67.3%
33/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypermagnesmia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypoglycemia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypophosphatemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
34.7%
17/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hyperkalemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
34.7%
17/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypokalemia
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
33.3%
3/9 • Baseline to study completion up to 9 years
|
22.4%
11/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hyponatremia
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
44.4%
4/9 • Baseline to study completion up to 9 years
|
22.4%
11/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypernatremia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Investigations
Hypercholesteremia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Cardiac disorders
Sinus Brdaycardia
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
General disorders
Hyperhidrosis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Taste Alteration
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Ear and labyrinth disorders
Tinitus
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Speech Disorder
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Surgical and medical procedures
Treatment related to Secondary Malignancy
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
8.2%
4/49 • Baseline to study completion up to 9 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
16.3%
8/49 • Baseline to study completion up to 9 years
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
36.7%
18/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
22.2%
2/9 • Baseline to study completion up to 9 years
|
18.4%
9/49 • Baseline to study completion up to 9 years
|
|
Surgical and medical procedures
Urostomy stenosis
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Reproductive system and breast disorders
Vaginal hemmorrhage
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
2.0%
1/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Vision blurred
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
77.8%
7/9 • Baseline to study completion up to 9 years
|
59.2%
29/49 • Baseline to study completion up to 9 years
|
|
Vascular disorders
Vascular (other)
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
4.1%
2/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/9 • Baseline to study completion up to 9 years
|
32.7%
16/49 • Baseline to study completion up to 9 years
|
|
Gastrointestinal disorders
Voice Alteration
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
0.00%
0/49 • Baseline to study completion up to 9 years
|
|
Eye disorders
Watering Eyes
|
66.7%
2/3 • Baseline to study completion up to 9 years
|
33.3%
1/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
42.9%
21/49 • Baseline to study completion up to 9 years
|
|
Metabolism and nutrition disorders
Weight Gain
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
0.00%
0/3 • Baseline to study completion up to 9 years
|
11.1%
1/9 • Baseline to study completion up to 9 years
|
6.1%
3/49 • Baseline to study completion up to 9 years
|
Additional Information
Weber,Donna M.,M.D. / Lymphoma/Myeloma
UT MD Anderson Cancer Center
Phone: 713-792-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place