Trial Outcomes & Findings for S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma (NCT NCT00040937)
NCT ID: NCT00040937
Last Updated: 2016-12-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
4-7 years
Results posted on
2016-12-08
Participant Flow
Patients were recruited at participating cooperative group institutions.
Participant milestones
| Measure |
Treatment Arm
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
|
|---|---|
|
Induction/PBSC Mobilization
STARTED
|
147
|
|
Induction/PBSC Mobilization
COMPLETED
|
110
|
|
Induction/PBSC Mobilization
NOT COMPLETED
|
37
|
|
Autologous PBSCT
STARTED
|
108
|
|
Autologous PBSCT
COMPLETED
|
77
|
|
Autologous PBSCT
NOT COMPLETED
|
31
|
|
Maintenance
STARTED
|
76
|
|
Maintenance
COMPLETED
|
76
|
|
Maintenance
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=142 Participants
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
|
|---|---|
|
Age, Continuous
|
57 years
FULL_RANGE 23-66 • n=5 Participants
|
|
Gender
Female
|
56 Participants
n=5 Participants
|
|
Gender
Male
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-7 yearsOutcome measures
| Measure |
Induction/PBSC Mobilization
n=142 Participants
|
|---|---|
|
Overall Survival
|
.64 proportion surviving at 4 years
Interval 0.55 to 0.74
|
SECONDARY outcome
Timeframe: InductionPopulation: All participants receiving at least one dose of induction therapy
To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.
Outcome measures
| Measure |
Induction/PBSC Mobilization
n=140 Participants
|
|---|---|
|
Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
|
2 Participants
|
Adverse Events
Induction/PBSC Mobilization
Serious events: 7 serious events
Other events: 140 other events
Deaths: 0 deaths
Autologous PBSCT
Serious events: 0 serious events
Other events: 105 other events
Deaths: 0 deaths
Prednisone + Thalidomide
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction/PBSC Mobilization
n=140 participants at risk
|
Autologous PBSCT
n=105 participants at risk
|
Prednisone + Thalidomide
n=76 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular arrhythmia
|
1.4%
2/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
GI-other
|
0.71%
1/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Infections and infestations
Respiratory infect w/ neutrop
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
1.3%
1/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.71%
1/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.71%
1/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Vascular disorders
Thrombosis/embolism
|
1.4%
2/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
Other adverse events
| Measure |
Induction/PBSC Mobilization
n=140 participants at risk
|
Autologous PBSCT
n=105 participants at risk
|
Prednisone + Thalidomide
n=76 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
52.1%
73/140 • Report through 4/10/2007 to match data reported in MS.
|
89.5%
94/105 • Report through 4/10/2007 to match data reported in MS.
|
30.3%
23/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
61.0%
64/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Blood and lymphatic system disorders
Transplant-pRBC transfusion
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Blood and lymphatic system disorders
Transplant-plt transfusion
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Cardiac disorders
Arrhythmia, NOS
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Cardiac disorders
Palpitations
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Endocrine disorders
Cushingoid appearance
|
8.6%
12/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Eye disorders
Blurred vision
|
10.0%
14/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Eye disorders
Cataract
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Eye disorders
Dry eye
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
14.3%
15/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
60.7%
85/140 • Report through 4/10/2007 to match data reported in MS.
|
16.2%
17/105 • Report through 4/10/2007 to match data reported in MS.
|
46.1%
35/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
15.0%
21/140 • Report through 4/10/2007 to match data reported in MS.
|
80.0%
84/105 • Report through 4/10/2007 to match data reported in MS.
|
15.8%
12/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
13.6%
19/140 • Report through 4/10/2007 to match data reported in MS.
|
26.7%
28/105 • Report through 4/10/2007 to match data reported in MS.
|
17.1%
13/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Esophagitis/dysphagia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
38.1%
40/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
GI Mucositis, NOS
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Mouth dryness
|
5.7%
8/140 • Report through 4/10/2007 to match data reported in MS.
|
8.6%
9/105 • Report through 4/10/2007 to match data reported in MS.
|
10.5%
8/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Nausea
|
38.6%
54/140 • Report through 4/10/2007 to match data reported in MS.
|
91.4%
96/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
6.4%
9/140 • Report through 4/10/2007 to match data reported in MS.
|
72.4%
76/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
24/140 • Report through 4/10/2007 to match data reported in MS.
|
64.8%
68/105 • Report through 4/10/2007 to match data reported in MS.
|
9.2%
7/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Edema
|
43.6%
61/140 • Report through 4/10/2007 to match data reported in MS.
|
47.6%
50/105 • Report through 4/10/2007 to match data reported in MS.
|
31.6%
24/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Fatigue/malaise/lethargy
|
81.4%
114/140 • Report through 4/10/2007 to match data reported in MS.
|
87.6%
92/105 • Report through 4/10/2007 to match data reported in MS.
|
68.4%
52/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Fever without neutropenia
|
27.1%
38/140 • Report through 4/10/2007 to match data reported in MS.
|
53.3%
56/105 • Report through 4/10/2007 to match data reported in MS.
|
15.8%
12/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Pain-other
|
15.7%
22/140 • Report through 4/10/2007 to match data reported in MS.
|
16.2%
17/105 • Report through 4/10/2007 to match data reported in MS.
|
28.9%
22/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Rigors/chills
|
12.9%
18/140 • Report through 4/10/2007 to match data reported in MS.
|
34.3%
36/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
General disorders
Sweating
|
11.4%
16/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
27.1%
38/140 • Report through 4/10/2007 to match data reported in MS.
|
13.3%
14/105 • Report through 4/10/2007 to match data reported in MS.
|
47.4%
36/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
18.1%
19/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Infections and infestations
Respiratory infection, unk ANC
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Injury, poisoning and procedural complications
Local injection site reaction
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Alkaline phosphatase increase
|
13.6%
19/140 • Report through 4/10/2007 to match data reported in MS.
|
12.4%
13/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Bilirubin increase
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
12.4%
13/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Creatinine increase
|
11.4%
16/140 • Report through 4/10/2007 to match data reported in MS.
|
18.1%
19/105 • Report through 4/10/2007 to match data reported in MS.
|
15.8%
12/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Hypercholesterolemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Leukopenia
|
25.7%
36/140 • Report through 4/10/2007 to match data reported in MS.
|
85.7%
90/105 • Report through 4/10/2007 to match data reported in MS.
|
34.2%
26/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Lymphopenia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
13.3%
14/105 • Report through 4/10/2007 to match data reported in MS.
|
13.2%
10/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Neutropenia/granulocytopenia
|
17.9%
25/140 • Report through 4/10/2007 to match data reported in MS.
|
92.4%
97/105 • Report through 4/10/2007 to match data reported in MS.
|
18.4%
14/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
SGOT (AST) increase
|
11.4%
16/140 • Report through 4/10/2007 to match data reported in MS.
|
14.3%
15/105 • Report through 4/10/2007 to match data reported in MS.
|
21.1%
16/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
SGPT (ALT) increase
|
17.9%
25/140 • Report through 4/10/2007 to match data reported in MS.
|
15.2%
16/105 • Report through 4/10/2007 to match data reported in MS.
|
23.7%
18/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Thrombocytopenia
|
37.1%
52/140 • Report through 4/10/2007 to match data reported in MS.
|
86.7%
91/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Transplant-thrombocytopenia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Weight gain
|
15.0%
21/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
31.6%
24/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Investigations
Weight loss
|
6.4%
9/140 • Report through 4/10/2007 to match data reported in MS.
|
11.4%
12/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.6%
26/140 • Report through 4/10/2007 to match data reported in MS.
|
47.6%
50/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
49.3%
69/140 • Report through 4/10/2007 to match data reported in MS.
|
32.4%
34/105 • Report through 4/10/2007 to match data reported in MS.
|
51.3%
39/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
8.6%
9/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.9%
25/140 • Report through 4/10/2007 to match data reported in MS.
|
33.3%
35/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
32.1%
45/140 • Report through 4/10/2007 to match data reported in MS.
|
40.0%
42/105 • Report through 4/10/2007 to match data reported in MS.
|
19.7%
15/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
30/140 • Report through 4/10/2007 to match data reported in MS.
|
32.4%
34/105 • Report through 4/10/2007 to match data reported in MS.
|
14.5%
11/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
14/140 • Report through 4/10/2007 to match data reported in MS.
|
20.0%
21/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
14/140 • Report through 4/10/2007 to match data reported in MS.
|
21.9%
23/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
16.2%
17/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Metabolism and nutrition disorders
Metabolic-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
16/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
17.1%
13/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
52.1%
73/140 • Report through 4/10/2007 to match data reported in MS.
|
39.0%
41/105 • Report through 4/10/2007 to match data reported in MS.
|
38.2%
29/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Chest pain,not cardio or pleur
|
6.4%
9/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Joint,muscle,bone-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not neuro)
|
7.1%
10/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
10.5%
8/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.7%
29/140 • Report through 4/10/2007 to match data reported in MS.
|
15.2%
16/105 • Report through 4/10/2007 to match data reported in MS.
|
13.2%
10/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia, NOS
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Dizziness/light headedness
|
27.9%
39/140 • Report through 4/10/2007 to match data reported in MS.
|
21.9%
23/105 • Report through 4/10/2007 to match data reported in MS.
|
25.0%
19/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Headache
|
14.3%
20/140 • Report through 4/10/2007 to match data reported in MS.
|
33.3%
35/105 • Report through 4/10/2007 to match data reported in MS.
|
13.2%
10/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Memory loss
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Neuro-other
|
5.7%
8/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Neuropathic pain
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Sensory neuropathy
|
59.3%
83/140 • Report through 4/10/2007 to match data reported in MS.
|
15.2%
16/105 • Report through 4/10/2007 to match data reported in MS.
|
78.9%
60/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Somnolence/consciousness loss
|
10.7%
15/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Taste disturbance
|
10.0%
14/140 • Report through 4/10/2007 to match data reported in MS.
|
7.6%
8/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Tremor
|
14.3%
20/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
12.1%
17/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
21.1%
16/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Psychiatric disorders
Anxiety/agitation
|
15.0%
21/140 • Report through 4/10/2007 to match data reported in MS.
|
21.0%
22/105 • Report through 4/10/2007 to match data reported in MS.
|
17.1%
13/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Psychiatric disorders
Depression
|
13.6%
19/140 • Report through 4/10/2007 to match data reported in MS.
|
9.5%
10/105 • Report through 4/10/2007 to match data reported in MS.
|
23.7%
18/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Psychiatric disorders
Insomnia
|
20.0%
28/140 • Report through 4/10/2007 to match data reported in MS.
|
19.0%
20/105 • Report through 4/10/2007 to match data reported in MS.
|
19.7%
15/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Psychiatric disorders
Personality/behavioral change
|
8.6%
12/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Reproductive system and breast disorders
Sexual/reproductive-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
18/140 • Report through 4/10/2007 to match data reported in MS.
|
25.7%
27/105 • Report through 4/10/2007 to match data reported in MS.
|
23.7%
18/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.9%
39/140 • Report through 4/10/2007 to match data reported in MS.
|
23.8%
25/105 • Report through 4/10/2007 to match data reported in MS.
|
22.4%
17/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.7%
8/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Lung-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusions
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
5.7%
6/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/infiltrates
|
5.0%
7/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
9/140 • Report through 4/10/2007 to match data reported in MS.
|
33.3%
35/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Skin and subcutaneous tissue disorders
Eryth/rash/eruption/desq, NOS
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
9.2%
7/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
9/140 • Report through 4/10/2007 to match data reported in MS.
|
15.2%
16/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
30.0%
42/140 • Report through 4/10/2007 to match data reported in MS.
|
33.3%
35/105 • Report through 4/10/2007 to match data reported in MS.
|
13.2%
10/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
7.9%
6/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/105 • Report through 4/10/2007 to match data reported in MS.
|
6.6%
5/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Vascular disorders
Hypertension
|
0.00%
0/140 • Report through 4/10/2007 to match data reported in MS.
|
8.6%
9/105 • Report through 4/10/2007 to match data reported in MS.
|
11.8%
9/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Vascular disorders
Hypotension
|
15.0%
21/140 • Report through 4/10/2007 to match data reported in MS.
|
25.7%
27/105 • Report through 4/10/2007 to match data reported in MS.
|
5.3%
4/76 • Report through 4/10/2007 to match data reported in MS.
|
|
Vascular disorders
Thrombosis/embolism
|
12.1%
17/140 • Report through 4/10/2007 to match data reported in MS.
|
6.7%
7/105 • Report through 4/10/2007 to match data reported in MS.
|
0.00%
0/76 • Report through 4/10/2007 to match data reported in MS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place