Trial Outcomes & Findings for Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib (NCT NCT01415882)
NCT ID: NCT01415882
Last Updated: 2025-09-05
Results Overview
A confirmed response is defined as stringent complete response, complete response (CR), very good partial response, or partial response (PR) noted as the objective status on 2 separate evaluations while receiving ixazomib citrate with or without dexamethasone. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
2.5 years
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
36
|
35
|
37
|
24
|
|
Overall Study
COMPLETED
|
32
|
35
|
35
|
33
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib
Baseline characteristics by cohort
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone, Closed to Accrual)
n=33 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=36 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=37 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
68.1 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
68.3 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
156 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 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
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
164 Participants
n=8 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
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsPopulation: All eligible patients that received treatment and a disease evaluation.
A confirmed response is defined as stringent complete response, complete response (CR), very good partial response, or partial response (PR) noted as the objective status on 2 separate evaluations while receiving ixazomib citrate with or without dexamethasone. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.
Outcome measures
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=32 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=36 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Proportion of Confirmed Responses With Ixazomib Citrate Alone (Arm A [Closed]), Ixazomib Citrate With Dexamethasone (Arms B + C), or With Dexamethasone and Cyclophosphamide (Arm D), or With Dexamethasone, Cyclophosphamide, Daratumumab (Arm E)
|
0.1563 proportion of participants
|
0.3143 proportion of participants
|
0.5429 proportion of participants
|
0.6667 proportion of participants
|
0.750 proportion of participants
|
SECONDARY outcome
Timeframe: 2.5 yearsEstimated by the number of patients who achieve a confirmed response at any time (with single agent ixazomib citrate or ixazomib citrate plus dexamethasone) divided by the number of evaluable patients. 95% confidence intervals for the true confirmed response rate will be calculated by the exact binomial method.
Outcome measures
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=32 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Confirmed Response Rate With the Addition of Dexamethasone (Arm A Only)
|
0.3438 proportion of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: All eligible patients that started treatment.
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=32 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=33 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival
|
NA Months
Not enough events occurred to calculate the Median or confidence intervals
|
NA Months
Interval 26.3 to
Not enough events occurred to calculate the Median or upper confidence interval
|
NA Months
Interval 25.5 to
Not enough events occurred to calculate the Median or upper confidence interval
|
NA Months
Not enough events occurred to calculate the Median or confidence intervals
|
NA Months
Not enough events occurred to calculate the Median or confidence intervals
|
SECONDARY outcome
Timeframe: From registration to disease progression while receiving ixazomib citrate and dexamethasone, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 2.5 yearsDate of progression will be defined as the date that the criteria for progressive disease were first met after initiation of dexamethasone. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=32 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 Participants
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=33 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 Participants
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Event-free Survival
|
11.5 Months
Interval 9.1 to 20.3
|
8.4 Months
Interval 4.5 to 12.8
|
7.8 Months
Interval 4.6 to 11.9
|
18.8 Months
Interval 10.2 to 30.4
|
29.5 Months
Interval 18.8 to 39.6
|
SECONDARY outcome
Timeframe: Up to 30 days after the last day of study drug treatmentGraded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Ixazomib Citrate and Dexamethasone)
Serious events: 16 serious events
Other events: 33 other events
Deaths: 5 deaths
Arm B (Ixazomib Citrate and Dexamethasone)
Serious events: 11 serious events
Other events: 35 other events
Deaths: 5 deaths
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Serious events: 11 serious events
Other events: 35 other events
Deaths: 4 deaths
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Serious events: 14 serious events
Other events: 36 other events
Deaths: 8 deaths
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Serious events: 14 serious events
Other events: 24 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=33 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=35 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 participants at risk
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=36 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
8.3%
3/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Myocardial infarction
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Eye disorders
Vitreous hemorrhage
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.6%
2/36 • Number of events 2 • 2.5 years
|
8.3%
2/24 • Number of events 2 • 2.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
16.7%
4/24 • Number of events 4 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
General disorders
Edema limbs
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
General disorders
Fever
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
12.5%
3/24 • Number of events 4 • 2.5 years
|
|
Infections and infestations
Lung infection
|
9.1%
3/33 • Number of events 4 • 2.5 years
|
11.4%
4/35 • Number of events 6 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.6%
2/36 • Number of events 2 • 2.5 years
|
12.5%
3/24 • Number of events 5 • 2.5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/33 • 2.5 years
|
5.7%
2/35 • Number of events 5 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Skin infection
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Upper respiratory infection
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • Number of events 3 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Uterine infection
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Creatinine increased
|
9.1%
3/33 • Number of events 3 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Investigations
Neutrophil count decreased
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Platelet count decreased
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
11.1%
4/36 • Number of events 4 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
16.7%
4/24 • Number of events 4 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Cognitive disturbance
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Delirium
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
8.3%
2/24 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
12.5%
3/24 • Number of events 4 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
8.3%
2/24 • Number of events 4 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
Other adverse events
| Measure |
Arm A (Ixazomib Citrate and Dexamethasone)
n=33 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Ixazomib Citrate and Dexamethasone)
n=35 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
n=35 participants at risk
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
n=36 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
n=24 participants at risk
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 3 • 2.5 years
|
8.3%
2/24 • Number of events 3 • 2.5 years
|
|
Infections and infestations
Wound infection
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
CD4 lymphocytes decreased
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Creatinine increased
|
33.3%
11/33 • Number of events 130 • 2.5 years
|
37.1%
13/35 • Number of events 59 • 2.5 years
|
25.7%
9/35 • Number of events 15 • 2.5 years
|
52.8%
19/36 • Number of events 127 • 2.5 years
|
54.2%
13/24 • Number of events 59 • 2.5 years
|
|
Investigations
INR increased
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Lymphocyte count decreased
|
30.3%
10/33 • Number of events 181 • 2.5 years
|
22.9%
8/35 • Number of events 47 • 2.5 years
|
31.4%
11/35 • Number of events 55 • 2.5 years
|
69.4%
25/36 • Number of events 394 • 2.5 years
|
91.7%
22/24 • Number of events 307 • 2.5 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Investigations
Neutrophil count decreased
|
45.5%
15/33 • Number of events 52 • 2.5 years
|
42.9%
15/35 • Number of events 31 • 2.5 years
|
48.6%
17/35 • Number of events 59 • 2.5 years
|
63.9%
23/36 • Number of events 135 • 2.5 years
|
33.3%
8/24 • Number of events 44 • 2.5 years
|
|
Investigations
Platelet count decreased
|
81.8%
27/33 • Number of events 244 • 2.5 years
|
74.3%
26/35 • Number of events 148 • 2.5 years
|
80.0%
28/35 • Number of events 144 • 2.5 years
|
72.2%
26/36 • Number of events 371 • 2.5 years
|
70.8%
17/24 • Number of events 69 • 2.5 years
|
|
Investigations
Weight gain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Investigations
Weight loss
|
3.0%
1/33 • Number of events 19 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
9/33 • Number of events 22 • 2.5 years
|
17.1%
6/35 • Number of events 59 • 2.5 years
|
11.4%
4/35 • Number of events 12 • 2.5 years
|
44.4%
16/36 • Number of events 237 • 2.5 years
|
91.7%
22/24 • Number of events 291 • 2.5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 12 • 2.5 years
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 3 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Eye disorders
Blurred vision
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Eye disorders
Cataract
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Eye disorders
Vitreous hemorrhage
|
3.0%
1/33 • Number of events 7 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
1/33 • Number of events 4 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Bloating
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
54.5%
18/33 • Number of events 122 • 2.5 years
|
54.3%
19/35 • Number of events 100 • 2.5 years
|
60.0%
21/35 • Number of events 134 • 2.5 years
|
66.7%
24/36 • Number of events 147 • 2.5 years
|
75.0%
18/24 • Number of events 61 • 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
78.8%
26/33 • Number of events 234 • 2.5 years
|
68.6%
24/35 • Number of events 174 • 2.5 years
|
71.4%
25/35 • Number of events 113 • 2.5 years
|
80.6%
29/36 • Number of events 208 • 2.5 years
|
70.8%
17/24 • Number of events 146 • 2.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
1/33 • Number of events 5 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 5 • 2.5 years
|
12.5%
3/24 • Number of events 5 • 2.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
84.8%
28/33 • Number of events 144 • 2.5 years
|
54.3%
19/35 • Number of events 71 • 2.5 years
|
65.7%
23/35 • Number of events 103 • 2.5 years
|
77.8%
28/36 • Number of events 124 • 2.5 years
|
66.7%
16/24 • Number of events 103 • 2.5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
51.5%
17/33 • Number of events 37 • 2.5 years
|
25.7%
9/35 • Number of events 15 • 2.5 years
|
31.4%
11/35 • Number of events 22 • 2.5 years
|
30.6%
11/36 • Number of events 19 • 2.5 years
|
29.2%
7/24 • Number of events 23 • 2.5 years
|
|
General disorders
Edema limbs
|
39.4%
13/33 • Number of events 114 • 2.5 years
|
40.0%
14/35 • Number of events 120 • 2.5 years
|
40.0%
14/35 • Number of events 92 • 2.5 years
|
58.3%
21/36 • Number of events 145 • 2.5 years
|
70.8%
17/24 • Number of events 224 • 2.5 years
|
|
General disorders
Fatigue
|
87.9%
29/33 • Number of events 430 • 2.5 years
|
94.3%
33/35 • Number of events 441 • 2.5 years
|
82.9%
29/35 • Number of events 355 • 2.5 years
|
94.4%
34/36 • Number of events 514 • 2.5 years
|
91.7%
22/24 • Number of events 421 • 2.5 years
|
|
General disorders
Fever
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
General disorders
Malaise
|
3.0%
1/33 • Number of events 4 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
General disorders
Non-cardiac chest pain
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
General disorders
Pain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 2 • 2.5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Infections and infestations
Upper respiratory infection
|
12.1%
4/33 • Number of events 4 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
8.3%
3/36 • Number of events 3 • 2.5 years
|
12.5%
3/24 • Number of events 5 • 2.5 years
|
|
Investigations
White blood cell decreased
|
15.2%
5/33 • Number of events 24 • 2.5 years
|
20.0%
7/35 • Number of events 13 • 2.5 years
|
25.7%
9/35 • Number of events 24 • 2.5 years
|
25.0%
9/36 • Number of events 48 • 2.5 years
|
29.2%
7/24 • Number of events 24 • 2.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
3/33 • Number of events 3 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.6%
2/36 • Number of events 5 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
3/33 • Number of events 13 • 2.5 years
|
5.7%
2/35 • Number of events 8 • 2.5 years
|
5.7%
2/35 • Number of events 7 • 2.5 years
|
13.9%
5/36 • Number of events 57 • 2.5 years
|
25.0%
6/24 • Number of events 57 • 2.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.0%
1/33 • Number of events 3 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
2/33 • Number of events 3 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
5.6%
2/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
8.3%
2/24 • Number of events 5 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.0%
1/33 • Number of events 4 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.6%
2/36 • Number of events 2 • 2.5 years
|
8.3%
2/24 • Number of events 18 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
2.8%
1/36 • Number of events 4 • 2.5 years
|
8.3%
2/24 • Number of events 2 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.7%
2/35 • Number of events 3 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.7%
2/35 • Number of events 5 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Cognitive disturbance
|
33.3%
11/33 • Number of events 36 • 2.5 years
|
22.9%
8/35 • Number of events 48 • 2.5 years
|
14.3%
5/35 • Number of events 59 • 2.5 years
|
36.1%
13/36 • Number of events 89 • 2.5 years
|
16.7%
4/24 • Number of events 11 • 2.5 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 3 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Nervous system disorders
Dysgeusia
|
3.0%
1/33 • Number of events 5 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 6 • 2.5 years
|
2.8%
1/36 • Number of events 1 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 4 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
8.3%
2/24 • Number of events 5 • 2.5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 5 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
11/33 • Number of events 30 • 2.5 years
|
20.0%
7/35 • Number of events 93 • 2.5 years
|
22.9%
8/35 • Number of events 50 • 2.5 years
|
22.2%
8/36 • Number of events 34 • 2.5 years
|
33.3%
8/24 • Number of events 117 • 2.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
75.8%
25/33 • Number of events 346 • 2.5 years
|
88.6%
31/35 • Number of events 345 • 2.5 years
|
77.1%
27/35 • Number of events 384 • 2.5 years
|
69.4%
25/36 • Number of events 439 • 2.5 years
|
83.3%
20/24 • Number of events 363 • 2.5 years
|
|
Nervous system disorders
Spasticity
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 7 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Nervous system disorders
Tremor
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
2.8%
1/36 • Number of events 8 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Number of events 2 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/33 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 20 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • Number of events 13 • 2.5 years
|
5.7%
2/35 • Number of events 12 • 2.5 years
|
14.3%
5/35 • Number of events 68 • 2.5 years
|
25.0%
9/36 • Number of events 29 • 2.5 years
|
20.8%
5/24 • Number of events 22 • 2.5 years
|
|
Psychiatric disorders
Irritability
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
5.7%
2/35 • Number of events 2 • 2.5 years
|
2.8%
1/36 • Number of events 3 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Psychiatric disorders
Suicidal ideation
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 15 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
8.3%
2/24 • Number of events 2 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 3 • 2.5 years
|
12.5%
3/24 • Number of events 3 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 6 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 2 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.0%
1/33 • Number of events 13 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 2 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.9%
1/35 • Number of events 1 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
39.4%
13/33 • Number of events 30 • 2.5 years
|
37.1%
13/35 • Number of events 53 • 2.5 years
|
31.4%
11/35 • Number of events 31 • 2.5 years
|
22.2%
8/36 • Number of events 32 • 2.5 years
|
41.7%
10/24 • Number of events 23 • 2.5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
4.2%
1/24 • Number of events 1 • 2.5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
8.3%
2/24 • Number of events 2 • 2.5 years
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
2.8%
1/36 • Number of events 5 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
0.00%
0/24 • 2.5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/33 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/35 • 2.5 years
|
0.00%
0/36 • 2.5 years
|
8.3%
2/24 • Number of events 4 • 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place