Trial Outcomes & Findings for Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia (NCT NCT00352365)
NCT ID: NCT00352365
Last Updated: 2022-02-11
Results Overview
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2022-02-11
Participant Flow
Participant milestones
| Measure |
Lenalidomide
Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|
|
Induction Therapy
STARTED
|
41
|
|
Induction Therapy
Eligible
|
38
|
|
Induction Therapy
Eligible and Began Protocol Therapy
|
37
|
|
Induction Therapy
COMPLETED
|
14
|
|
Induction Therapy
NOT COMPLETED
|
27
|
|
Maintenance Therapy
STARTED
|
12
|
|
Maintenance Therapy
Eligible and Began Protocol Therapy
|
8
|
|
Maintenance Therapy
COMPLETED
|
0
|
|
Maintenance Therapy
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Lenalidomide
Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|
|
Induction Therapy
Adverse Event
|
7
|
|
Induction Therapy
Progression/Relapse
|
8
|
|
Induction Therapy
Death
|
7
|
|
Induction Therapy
Not protocol specified
|
1
|
|
Induction Therapy
Not eligible
|
3
|
|
Induction Therapy
Death before starting protocol therapy
|
1
|
|
Maintenance Therapy
Progression/Relapse
|
3
|
|
Maintenance Therapy
Death
|
2
|
|
Maintenance Therapy
Not protocol specified
|
3
|
|
Maintenance Therapy
Not eligible
|
4
|
Baseline Characteristics
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Induction Therapy
n=37 Participants
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
|---|---|
|
Age, Continuous
|
73.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
|
Hispanic
Yes
|
1 participants
n=5 Participants
|
|
Hispanic
No
|
32 participants
n=5 Participants
|
|
Hispanic
Unknown
|
4 participants
n=5 Participants
|
|
Disease Onset
De Novo
|
16 participants
n=5 Participants
|
|
Disease Onset
Treatment related
|
2 participants
n=5 Participants
|
|
Disease Onset
MDS related
|
19 participants
n=5 Participants
|
|
Performance Status
0
|
7 participants
n=5 Participants
|
|
Performance Status
1
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who began protocol therapy
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
Outcome measures
| Measure |
Induction Therapy
n=37 Participants
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Complete Response
|
11 percentage of participants
Interval 3.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Induction Therapy
n=37 Participants
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
n=8 Participants
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Adult respiratory distress syndrome (ARDS)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Bilirubin (hyperbilirubinemia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac-ischemia/infarction
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cough
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Creatinine
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dermatology/Skin-Other (Specify)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
11 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
15 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
7 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Induration/fibrosis (skin and subcutaneous tissue)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lip/perioral
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
5 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
14 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
16 Participants
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
21 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pulmonary/Upper Respiratory-Other (Specify)
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Renal failure
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-high (hypernatremia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
Outcome measures
| Measure |
Induction Therapy
n=5 Participants
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
n=32 Participants
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Cytogenetic Abnormalities
|
8 Number of abnormalities
Interval 1.0 to 20.0
|
8 Number of abnormalities
Interval 0.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who began protocol therapy
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl. Partial remission (PR): ANC \>1,000/mcl, platelet count \>100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts \<5% with persistent Auer rods.
Outcome measures
| Measure |
Induction Therapy
n=37 Participants
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Total Response
|
14 percentage of participants
Interval 5.0 to 29.0
|
—
|
Adverse Events
Induction Therapy
Serious events: 24 serious events
Other events: 34 other events
Deaths: 0 deaths
Maintenance Therapy
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Therapy
n=37 participants at risk
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
n=8 participants at risk
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.5%
5/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Colon
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
8.1%
3/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
8.1%
3/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2.7%
1/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
AST, SGOT
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Investigations
Lymphopenia
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
Platelets
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
21.6%
8/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Nervous system disorders
Pain - Head/headache
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Nervous system disorders
Syncope (fainting)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
8.1%
3/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.7%
1/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
Other adverse events
| Measure |
Induction Therapy
n=37 participants at risk
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
|
Maintenance Therapy
n=8 participants at risk
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.7%
11/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
62.2%
23/37 • Up to 5 years
|
62.5%
5/8 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.6%
8/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
18.9%
7/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
General disorders
Edema: limb
|
24.3%
9/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
48.6%
18/37 • Up to 5 years
|
62.5%
5/8 • Up to 5 years
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
General disorders
Pain - Pain NOS
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
General disorders
Rigors/chills
|
10.8%
4/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
13.5%
5/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.8%
4/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
AST, SGOT
|
16.2%
6/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Investigations
Alkaline phosphatase
|
5.4%
2/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
24.3%
9/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Investigations
Creatinine
|
21.6%
8/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Investigations
Leukocytes (total WBC)
|
54.1%
20/37 • Up to 5 years
|
62.5%
5/8 • Up to 5 years
|
|
Investigations
Lymphopenia
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
54.1%
20/37 • Up to 5 years
|
62.5%
5/8 • Up to 5 years
|
|
Investigations
Platelets
|
64.9%
24/37 • Up to 5 years
|
62.5%
5/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
21.6%
8/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
6/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
29.7%
11/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
40.5%
15/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
10.8%
4/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.8%
4/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
18.9%
7/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
10.8%
4/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: motor
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
10.8%
4/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Nervous system disorders
Pain - Head/headache
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
5.4%
2/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
10.8%
4/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
6/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.2%
6/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
8.1%
3/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
5.4%
2/37 • Up to 5 years
|
0.00%
0/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
2/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
|
10.8%
4/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
18.9%
7/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
24.3%
9/37 • Up to 5 years
|
25.0%
2/8 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/37 • Up to 5 years
|
12.5%
1/8 • Up to 5 years
|
Additional Information
Study Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60