Trial Outcomes & Findings for S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis (NCT NCT00064337)
NCT ID: NCT00064337
Last Updated: 2018-08-09
Results Overview
Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
Treatment
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.
Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.
Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).
Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0.
Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
filgrastim
cyclophosphamide
dexamethasone
melphalan
thalidomide
peripheral blood
|
|---|---|
|
PBSCC or Induction/PBSCC
STARTED
|
93
|
|
PBSCC or Induction/PBSCC
COMPLETED
|
73
|
|
PBSCC or Induction/PBSCC
NOT COMPLETED
|
20
|
|
Transplant
STARTED
|
67
|
|
Transplant
COMPLETED
|
46
|
|
Transplant
NOT COMPLETED
|
21
|
|
Maintenance
STARTED
|
13
|
|
Maintenance
COMPLETED
|
3
|
|
Maintenance
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Treatment
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.
Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.
Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).
Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0.
Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
filgrastim
cyclophosphamide
dexamethasone
melphalan
thalidomide
peripheral blood
|
|---|---|
|
PBSCC or Induction/PBSCC
Not protocol-specified
|
7
|
|
PBSCC or Induction/PBSCC
Adverse Event
|
6
|
|
PBSCC or Induction/PBSCC
Progression
|
3
|
|
PBSCC or Induction/PBSCC
Patient Refusal
|
2
|
|
PBSCC or Induction/PBSCC
Death
|
2
|
|
Transplant
Adverse Event
|
9
|
|
Transplant
Not protocol-specified
|
5
|
|
Transplant
Death
|
3
|
|
Transplant
Patient Refusal
|
2
|
|
Transplant
Progression
|
2
|
|
Maintenance
Adverse Event
|
3
|
|
Maintenance
Progression
|
2
|
|
Maintenance
On treatment at time of analysis
|
2
|
|
Maintenance
Not protocol-specified
|
2
|
|
Maintenance
Death
|
1
|
Baseline Characteristics
S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
Baseline characteristics by cohort
| Measure |
Treatment
n=93 Participants
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.
Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.
Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).
Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0.
Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
filgrastim
cyclophosphamide
dexamethasone
melphalan
thalidomide
peripheral blood
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 yearsPopulation: Eligible and analyzable patients only.
Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.
Outcome measures
| Measure |
Treatment
n=93 Participants
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.
Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.
Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).
Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0.
Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
filgrastim
cyclophosphamide
dexamethasone
melphalan
thalidomide
peripheral blood
|
|---|---|
|
Overall Survival
|
68 Months
Interval 42.0 to
The upper limit of the 95% CI for the median had not yet been reached at time of analysis.
|
SECONDARY outcome
Timeframe: Until off studyOutcome measures
| Measure |
Treatment
n=23 Participants
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.
Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.
Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).
Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0.
Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
filgrastim
cyclophosphamide
dexamethasone
melphalan
thalidomide
peripheral blood
|
|---|---|
|
Hematologic Response
|
8 Participants
|
Adverse Events
PBSCC or Induction/PBSCC
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Autologous Transplants
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Dex/Thal
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PBSCC or Induction/PBSCC
n=92 participants at risk
Induction/PBSCC - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition
|
Autologous Transplants
n=65 participants at risk
Autologous Transplants � All patients
|
Dex/Thal
n=12 participants at risk
Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
|
|---|---|---|---|
|
Cardiac disorders
Cardiac General-Other
|
1.1%
1/92
|
0.00%
0/65
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.00%
0/92
|
1.5%
1/65
|
0.00%
0/12
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
1.1%
1/92
|
0.00%
0/65
|
0.00%
0/12
|
|
Cardiac disorders
SVT and nodal arrhythmia - Nodal/junctional
|
0.00%
0/92
|
1.5%
1/65
|
0.00%
0/12
|
|
General disorders
Constitutional Symptoms-Other
|
1.1%
1/92
|
1.5%
1/65
|
0.00%
0/12
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.00%
0/92
|
1.5%
1/65
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
0.00%
0/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/92
|
0.00%
0/65
|
0.00%
0/12
|
Other adverse events
| Measure |
PBSCC or Induction/PBSCC
n=92 participants at risk
Induction/PBSCC - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition
|
Autologous Transplants
n=65 participants at risk
Autologous Transplants � All patients
|
Dex/Thal
n=12 participants at risk
Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
2/92
|
30.8%
20/65
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Hemoglobin
|
46.7%
43/92
|
73.8%
48/65
|
50.0%
6/12
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
5.4%
5/92
|
12.3%
8/65
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac Arrhythmia-Other
|
1.1%
1/92
|
18.5%
12/65
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac General-Other
|
5.4%
5/92
|
10.8%
7/65
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Auditory/Ear-Other
|
1.1%
1/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Endocrine disorders
Cushingoid appearance
|
2.2%
2/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/92
|
3.1%
2/65
|
8.3%
1/12
|
|
Eye disorders
Ocular/Visual-Other
|
2.2%
2/92
|
3.1%
2/65
|
8.3%
1/12
|
|
Eye disorders
Vision-blurred vision
|
2.2%
2/92
|
6.2%
4/65
|
16.7%
2/12
|
|
Gastrointestinal disorders
Constipation
|
21.7%
20/92
|
20.0%
13/65
|
25.0%
3/12
|
|
Gastrointestinal disorders
Diarrhea
|
14.1%
13/92
|
63.1%
41/65
|
8.3%
1/12
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.2%
2/92
|
16.9%
11/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
1.1%
1/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
4.3%
4/92
|
9.2%
6/65
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hemorrhage, GI - Lower GI NOS
|
0.00%
0/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2.2%
2/92
|
20.0%
13/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
30.4%
28/92
|
67.7%
44/65
|
8.3%
1/12
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.4%
5/92
|
13.8%
9/65
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
18/92
|
44.6%
29/65
|
0.00%
0/12
|
|
General disorders
Edema: limb
|
23.9%
22/92
|
29.2%
19/65
|
16.7%
2/12
|
|
General disorders
Extremity-lower (gait/walking)
|
3.3%
3/92
|
1.5%
1/65
|
16.7%
2/12
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
44.6%
41/92
|
63.1%
41/65
|
58.3%
7/12
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
5.4%
5/92
|
30.8%
20/65
|
0.00%
0/12
|
|
General disorders
Pain-Other
|
2.2%
2/92
|
3.1%
2/65
|
8.3%
1/12
|
|
General disorders
Rigors/chills
|
2.2%
2/92
|
10.8%
7/65
|
0.00%
0/12
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
0.00%
0/92
|
6.2%
4/65
|
8.3%
1/12
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1.1%
1/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1.1%
1/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
1.1%
1/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
3.3%
3/92
|
4.6%
3/65
|
25.0%
3/12
|
|
Infections and infestations
Inf w/unknown ANC - Middle ear (otitis media)
|
0.00%
0/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
2.2%
2/92
|
10.8%
7/65
|
0.00%
0/12
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
7.6%
7/92
|
21.5%
14/65
|
0.00%
0/12
|
|
Investigations
AST, SGOT
|
6.5%
6/92
|
24.6%
16/65
|
8.3%
1/12
|
|
Investigations
Alkaline phosphatase
|
25.0%
23/92
|
35.4%
23/65
|
0.00%
0/12
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
4.3%
4/92
|
15.4%
10/65
|
8.3%
1/12
|
|
Investigations
Cholesterol, serum-high (hypercholesterolemia)
|
0.00%
0/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Investigations
Creatinine
|
22.8%
21/92
|
46.2%
30/65
|
41.7%
5/12
|
|
Investigations
GGT (gamma-glutamyl transpeptidase)
|
1.1%
1/92
|
15.4%
10/65
|
0.00%
0/12
|
|
Investigations
INR (of prothrombin time)
|
2.2%
2/92
|
4.6%
3/65
|
8.3%
1/12
|
|
Investigations
Leukocytes (total WBC)
|
19.6%
18/92
|
72.3%
47/65
|
41.7%
5/12
|
|
Investigations
Lymphopenia
|
9.8%
9/92
|
16.9%
11/65
|
16.7%
2/12
|
|
Investigations
Metabolic/Laboratory-Other
|
4.3%
4/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
10.9%
10/92
|
70.8%
46/65
|
25.0%
3/12
|
|
Investigations
PTT (Partial thromboplastin time)
|
1.1%
1/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Investigations
Platelets
|
46.7%
43/92
|
75.4%
49/65
|
25.0%
3/12
|
|
Investigations
Weight gain
|
6.5%
6/92
|
4.6%
3/65
|
16.7%
2/12
|
|
Investigations
Weight loss
|
1.1%
1/92
|
20.0%
13/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
26.1%
24/92
|
49.2%
32/65
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Anorexia
|
18.5%
17/92
|
36.9%
24/65
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
3.3%
3/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
17.4%
16/92
|
47.7%
31/65
|
16.7%
2/12
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
4/92
|
13.8%
9/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
35.9%
33/92
|
50.8%
33/65
|
50.0%
6/12
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
2.2%
2/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
8.7%
8/92
|
13.8%
9/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
5.4%
5/92
|
16.9%
11/65
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
4.3%
4/92
|
13.8%
9/65
|
16.7%
2/12
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
19.6%
18/92
|
23.1%
15/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
10.9%
10/92
|
27.7%
18/65
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
2.2%
2/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
9.8%
9/92
|
21.5%
14/65
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
7.6%
7/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Trunk
|
0.00%
0/92
|
0.00%
0/65
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
7.6%
7/92
|
7.7%
5/65
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
6.5%
6/92
|
7.7%
5/65
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
28.3%
26/92
|
13.8%
9/65
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
1.1%
1/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
3.3%
3/92
|
9.2%
6/65
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
15.2%
14/92
|
18.5%
12/65
|
8.3%
1/12
|
|
Nervous system disorders
Dizziness
|
14.1%
13/92
|
26.2%
17/65
|
25.0%
3/12
|
|
Nervous system disorders
Neuropathy: sensory
|
15.2%
14/92
|
12.3%
8/65
|
41.7%
5/12
|
|
Nervous system disorders
Ocular/Visual-Other
|
2.2%
2/92
|
3.1%
2/65
|
8.3%
1/12
|
|
Nervous system disorders
Pain - Head/headache
|
12.0%
11/92
|
21.5%
14/65
|
8.3%
1/12
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
2.2%
2/92
|
23.1%
15/65
|
0.00%
0/12
|
|
Psychiatric disorders
Confusion
|
2.2%
2/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
9.8%
9/92
|
24.6%
16/65
|
0.00%
0/12
|
|
Psychiatric disorders
Mood alteration - depression
|
1.1%
1/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
3.3%
3/92
|
1.5%
1/65
|
8.3%
1/12
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal failure
|
9.8%
9/92
|
13.8%
9/65
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.3%
3/92
|
13.8%
9/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.4%
5/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
9/92
|
23.1%
15/65
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.7%
20/92
|
26.2%
17/65
|
25.0%
3/12
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
0.00%
0/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
3/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
4.3%
4/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.4%
5/92
|
12.3%
8/65
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
2.2%
2/92
|
3.1%
2/65
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
1/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
3.3%
3/92
|
47.7%
31/65
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/92
|
9.2%
6/65
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.7%
8/92
|
29.2%
19/65
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.2%
2/92
|
4.6%
3/65
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Vascular disorders
Flushing
|
2.2%
2/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Vascular disorders
Hematoma
|
0.00%
0/92
|
6.2%
4/65
|
0.00%
0/12
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
10.9%
10/92
|
7.7%
5/65
|
0.00%
0/12
|
|
Vascular disorders
Hypertension
|
4.3%
4/92
|
10.8%
7/65
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
16.3%
15/92
|
32.3%
21/65
|
0.00%
0/12
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.3%
4/92
|
0.00%
0/65
|
8.3%
1/12
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60