Trial Outcomes & Findings for Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma (NCT NCT01054144)
NCT ID: NCT01054144
Last Updated: 2021-10-13
Results Overview
Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
up to 36 months
Results posted on
2021-10-13
Participant Flow
Participant milestones
| Measure |
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Response Adapted Therapy
n=27 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 36 monthsPopulation: Number of participants who received response adaptive therapy
Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
Outcome measures
| Measure |
Response Adapted Therapy
n=9 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
Single Agent Lenalidomide
Participants treated with single agent lenalidomide
|
|---|---|---|
|
Combined Therapy - Median Progression Free Survival
|
36 months
Interval 29.7 to
Not reached
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks up to 12 monthsPopulation: 1 participant could not be evaluated for response.
Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).
Outcome measures
| Measure |
Response Adapted Therapy
n=9 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
Single Agent Lenalidomide
n=26 Participants
Participants treated with single agent lenalidomide
|
|---|---|---|
|
Response Rate
Complete Response & Stringent Complete Response
|
1 Participants
|
4 Participants
|
|
Response Rate
Very Good Partial Response (VGPR)
|
1 Participants
|
3 Participants
|
|
Response Rate
Partial Response (PR)
|
2 Participants
|
12 Participants
|
|
Response Rate
Minimal Response (MR)
|
5 Participants
|
4 Participants
|
|
Response Rate
Stable Disease
|
0 Participants
|
3 Participants
|
|
Response Rate
Overall Response >/= PR
|
4 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Off Study Date, an average of 48 monthsNumber of participants with serious adverse events
Outcome measures
| Measure |
Response Adapted Therapy
n=27 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
Single Agent Lenalidomide
Participants treated with single agent lenalidomide
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
20 participants
|
—
|
SECONDARY outcome
Timeframe: First measure at 8 weeksThe progression free survival of patients treated with single agent lenalidomide
Outcome measures
| Measure |
Response Adapted Therapy
n=18 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
Single Agent Lenalidomide
Participants treated with single agent lenalidomide
|
|---|---|---|
|
Single Agent - Median Progressive Free Survival (PFS)
|
29 months
Interval 25.7 to 73.5
|
—
|
SECONDARY outcome
Timeframe: 1 YearThe 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach
Outcome measures
| Measure |
Response Adapted Therapy
n=27 Participants
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue
Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue
Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue
|
Single Agent Lenalidomide
Participants treated with single agent lenalidomide
|
|---|---|---|
|
Number of Participants With 1 Year Overall Survival (OS)
|
27 participants
|
—
|
Adverse Events
All Participants
Serious events: 20 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
All Participants
n=27 participants at risk
All participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
|
|---|---|
|
Cardiac disorders
General Cardiac Disorders - Other
|
11.1%
3/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Cardiac disorders
Hypertension
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Cardiac disorders
Hypotension
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Coagulation
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
General disorders - Other
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Death
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Colon Obstruction
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Vascular disorders
Hemorrhage, CNS
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Hemorrhage, Stomach
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Cholecystitis
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Colitis, Infectious (e.g. Clostridium difficile)
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Febrile neutropenia
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Infection -Blood
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Infection - Lung
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Infection - Other
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Cellulitis
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Infection - Bladder
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypercalcemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hyperglycemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Investigations -Other
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypokalemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Injury, poisoning and procedural complications
Fracture
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Vascular disorders
Cerebrovascular ischemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Confusion
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Psychiatric disorders
Mental status
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Chest wall pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Limb pain
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain -Other
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Renal and urinary disorders
Renal failure
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Vascular disorders
Vascular -Other
|
3.7%
1/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Vascular disorders
Non-myocardial vascular arterial ischemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
Other adverse events
| Measure |
All Participants
n=27 participants at risk
All participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
88.9%
24/27 • Number of events 46 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Diarrhea
|
85.2%
23/27 • Number of events 66 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Nausea
|
63.0%
17/27 • Number of events 37 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Metabolism and nutrition disorders
Anorexia
|
44.4%
12/27 • Number of events 27 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
44.4%
12/27 • Number of events 13 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Vomiting
|
40.7%
11/27 • Number of events 14 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Dehydration
|
33.3%
9/27 • Number of events 12 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
25.9%
7/27 • Number of events 9 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Distension/bloating, Abdominal
|
18.5%
5/27 • Number of events 6 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Dysphagia
|
18.5%
5/27 • Number of events 5 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis - oral cavity
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Dysgeusia
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Enteritis
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Gastritis
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Obstruction, GI - Colon
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Fatigue
|
85.2%
23/27 • Number of events 63 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Insomnia
|
48.1%
13/27 • Number of events 20 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Fever (in absence of neutropenia)
|
37.0%
10/27 • Number of events 25 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Metabolism and nutrition disorders
Weight loss
|
29.6%
8/27 • Number of events 11 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Rigors/chills
|
18.5%
5/27 • Number of events 7 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Diaphoresis
|
14.8%
4/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Metabolism and nutrition disorders
Weight gain
|
14.8%
4/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Constitutional symptoms - Other
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
92.6%
25/27 • Number of events 265 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
81.5%
22/27 • Number of events 264 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Blood and lymphatic system disorders
Low platelet count
|
74.1%
20/27 • Number of events 78 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Blood and lymphatic system disorders
Hemoglobin, low
|
59.3%
16/27 • Number of events 75 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -Other
|
51.9%
14/27 • Number of events 27 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
51.9%
14/27 • Number of events 15 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
40.7%
11/27 • Number of events 18 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
37.0%
10/27 • Number of events 18 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Rash, erythema multiforme
|
37.0%
10/27 • Number of events 16 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Brusing
|
33.3%
9/27 • Number of events 13 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Vascular disorders
Flushing
|
18.5%
5/27 • Number of events 8 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Rash, acne/acneiform
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Back pain
|
77.8%
21/27 • Number of events 45 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - extremity/limb
|
59.3%
16/27 • Number of events 29 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Headache
|
59.3%
16/27 • Number of events 26 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
44.4%
12/27 • Number of events 18 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Joint pain
|
37.0%
10/27 • Number of events 12 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Chest wall pain
|
22.2%
6/27 • Number of events 7 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Chest/thorax pain
|
18.5%
5/27 • Number of events 7 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Neck pain
|
18.5%
5/27 • Number of events 7 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain-throat/pharynx/larynx
|
18.5%
5/27 • Number of events 6 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - stomach
|
14.8%
4/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Pain - muscle
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - NOS
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Bone pain
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - lymph node
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - oral, gum
|
7.4%
2/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Breast pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Buttock pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - dental
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Ear and labyrinth disorders
Pain - external ear
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Eye disorders
Pain - eye
|
3.7%
1/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - face
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Gastrointestinal disorders
Gallbladder pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Oral cavity pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pelvic pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Sinus pain
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Pain - testicle
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Neuropathy, sensory
|
70.4%
19/27 • Number of events 38 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Dizziness
|
55.6%
15/27 • Number of events 29 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Nervous system disorders -Other
|
33.3%
9/27 • Number of events 15 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Tremor
|
29.6%
8/27 • Number of events 16 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Psychiatric disorders
Depression
|
22.2%
6/27 • Number of events 9 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Neuropathy, motor
|
18.5%
5/27 • Number of events 6 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Psychiatric disorders
Agitation/Iritability
|
22.2%
6/27 • Number of events 8 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
3/27 • Number of events 6 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Confusion
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Memory impairment
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Neuropathy, cranial
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Psychiatric disorders
Personality/Behavior changes
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Speech impairment
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Reproductive system and breast disorders
Cough
|
59.3%
16/27 • Number of events 28 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
51.9%
14/27 • Number of events 25 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Respirator, thoracic and mediastrinal disorders -Other
|
33.3%
9/27 • Number of events 14 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Loss or alteration of voice
|
14.8%
4/27 • Number of events 5 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal/sinus reaction
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction of airway
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Edema - limb
|
77.8%
21/27 • Number of events 52 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Edema -head and neck
|
11.1%
3/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Edema - trunk
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
44.4%
12/27 • Number of events 19 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakess, generalized
|
40.7%
11/27 • Number of events 12 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, extraocular
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, lower extremities
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Gait changes
|
18.5%
5/27 • Number of events 8 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, trunk
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Febrile neutropenia
|
22.2%
6/27 • Number of events 7 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Cellulitis
|
33.3%
9/27 • Number of events 11 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Infection -Other
|
14.8%
4/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Urinary Tract Infection
|
14.8%
4/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Bronchus infection
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Eye infection
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Pneumonia
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Sinus infection
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Upper airway infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Conjunctiva infection
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Peripheral nerve infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
General disorders
Gingivitus
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Nail infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
wound infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Bladder infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Colon infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Tooth infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Infections and infestations
Mucosal infection
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hyperglycemia
|
33.3%
9/27 • Number of events 13 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Creatinine
|
25.9%
7/27 • Number of events 14 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hyperkalemia
|
25.9%
7/27 • Number of events 8 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
ALT, SGPT high
|
14.8%
4/27 • Number of events 6 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hyperbilirubinemia
|
14.8%
4/27 • Number of events 9 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypoalbuminemia
|
11.1%
3/27 • Number of events 4 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Alkaline phosphatase
|
11.1%
3/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypokalemia
|
11.1%
3/27 • Number of events 5 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Investigations - Other
|
40.7%
11/27 • Number of events 12 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypercalcemia
|
7.4%
2/27 • Number of events 3 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypocalcemia
|
7.4%
2/27 • Number of events 5 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypoglycemia
|
7.4%
2/27 • Number of events 2 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
AST, SGOT
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypomagnesemia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
|
Investigations
Hypernatremia
|
3.7%
1/27 • Number of events 1 • Adverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place