Trial Outcomes & Findings for Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (NCT NCT02477215)
NCT ID: NCT02477215
Last Updated: 2020-10-22
Results Overview
Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Six months for each dosing cohort
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 70 mg/m\^2 days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Dose Escalation Phase
STARTED
|
4
|
8
|
6
|
|
Dose Escalation Phase
COMPLETED
|
3
|
6
|
6
|
|
Dose Escalation Phase
NOT COMPLETED
|
1
|
2
|
0
|
|
Fixed Dose Phase
STARTED
|
0
|
20
|
0
|
|
Fixed Dose Phase
COMPLETED
|
0
|
13
|
0
|
|
Fixed Dose Phase
NOT COMPLETED
|
0
|
7
|
0
|
Reasons for withdrawal
| Measure |
Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 70 mg/m\^2 days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Dose Escalation Phase
Physician Decision
|
1
|
2
|
0
|
|
Fixed Dose Phase
Physician Decision
|
0
|
7
|
0
|
Baseline Characteristics
Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase: Bendamustine (70 mg/m^2), MLN9708, Dex.
n=4 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 70 mg/m\^2 days 1 and 2
|
Dose Escalation Phase: Bendamustine (80 mg/m^2), MLN9708, Dex.
n=8 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Dose Escalation Phase: Bendamustine (90 mg/m^2), MLN9708, Dex.
n=6 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
Fixed Dose Phase
n=20 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Total
n=38 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
23 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
37 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
29 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
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
38 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Six months for each dosing cohortPopulation: All participants received at least ne dose of Bendamustine at either 70 mg/m\^2, 80 mg\^2 or 90 mg/m\^2.
Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=15 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Maximum Tolerated Dose of Bendamustine
|
80 mg/m^2
|
—
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.
Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=18 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Objective Response Rate
|
11 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.
Overall survival was determined as the average number of months subjects survived following enrollment.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=18 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Overall Survival (OS)
|
23.2 MONTHS
Interval 16.3 to 30.07
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: For this analysis, all 20 participants who received the fixed dose of 80 mg/m\^2 Bendamustine and all 8 participants who received Bendamustine (80 mg/m\^2) in the Dose Escalation phase, were combined.
This measure is the number of months participants remain free from evidence of disease.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=28 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.2 MONTHS
Interval 1.96 to 8.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.
Percentage of subject response rates at any point during the eight cycles.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=18 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Cumulative Response Rates in Patients After Eight Cycles.
|
28 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Subjects receiving the fixed dose of 80 mg/m\^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m\^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.
Median time in months participants maintain CR, PR or stable disease.
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=18 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Duration of Response (DoR)
|
5.1 MONTHS
Interval 1.0 to 5.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Six monthsA 3+3 design was employed. At each dose, three patients were initially evaluated. If no dose limiting toxicities were observed, the bendamustine dose was increased; if one dose limiting toxicity is observed, three additional patients were treated at that dose. A dose at which 2 DLTs were observed in 3 or 6 patients were judged to be too toxic and the lower dose was defined as the maximally tolerated dose (MTD).
Outcome measures
| Measure |
MLN9708, Bendamustine and Dexamethasone
n=3 Participants
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine:70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
n=6 Participants
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 80 mg/m\^2 days 1 and 2
|
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
n=6 Participants
MLN9708 : 4 mg, days 1, 8, 15.
Dexamethasone: 40 mg oral weekly.
Bendamustine: 90 mg/m\^2 days 1 and 2
|
|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone
Serious events: 8 serious events
Other events: 0 other events
Deaths: 8 deaths
Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone
n=3 participants at risk
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 70 mg/m\^2 on days 1 and 2
|
Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone
n=19 participants at risk
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 80 mg/m\^2 on days 1 and 2.
This reporting group includes subjects from both the Dose Escalation and Fixed Dose Phases who received Bendamustine at 80 mg/m\^2.
|
Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone
n=6 participants at risk
MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine: 90 mg/m\^2 on days 1 and 2
|
|---|---|---|---|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Cardiac disorders
Mobitz type 1
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 3 years
|
10.5%
2/19 • Number of events 2 • 3 years
|
0.00%
0/6 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 3 years
|
10.5%
2/19 • Number of events 2 • 3 years
|
0.00%
0/6 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbated COPD
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/19 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
General disorders
Fever
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
0.00%
0/3 • 3 years
|
5.3%
1/19 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/19 • 3 years
|
0.00%
0/6 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place