Trial Outcomes & Findings for UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy (NCT NCT00083551)
NCT ID: NCT00083551
Last Updated: 2015-11-23
Results Overview
Overall Survival at six years after initiating protocol therapy
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
668 participants
Primary outcome timeframe
6 Years
Results posted on
2015-11-23
Participant Flow
Participant milestones
| Measure |
Thalidomide
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
|
No Thalidomide
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
323
|
345
|
|
Overall Study
COMPLETED
|
323
|
345
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
Baseline characteristics by cohort
| Measure |
Thalidomide
n=323 Participants
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
|
No Thalidomide
n=345 Participants
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
|
Total
n=668 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>/= 60 to < 65 years
|
130 participants
n=5 Participants
|
129 participants
n=7 Participants
|
259 participants
n=5 Participants
|
|
Age, Customized
>/= 65 years
|
64 participants
n=5 Participants
|
72 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Age, Customized
< 60 years
|
129 participants
n=5 Participants
|
144 participants
n=7 Participants
|
273 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 YearsOverall Survival at six years after initiating protocol therapy
Outcome measures
| Measure |
Thalidomide
n=323 Participants
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
|
No Thalidomide
n=345 Participants
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
|
|---|---|---|
|
Overall Survival
|
65 percentage of participants
|
58 percentage of participants
|
Adverse Events
Thalidomide
Serious events: 323 serious events
Other events: 323 other events
Deaths: 0 deaths
No Thalidomide
Serious events: 345 serious events
Other events: 345 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thalidomide
n=323 participants at risk
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
|
No Thalidomide
n=345 participants at risk
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
|
|---|---|---|
|
Nervous system disorders
Grade4 Tremor
|
0.62%
2/323
|
0.29%
1/345
|
|
Nervous system disorders
Grade 3 Weakness (motor neuropathy)
|
17.0%
55/323
|
10.4%
36/345
|
|
Nervous system disorders
Grade 4 Weakness (motor neuropathy)
|
0.93%
3/323
|
1.4%
5/345
|
|
General disorders
Grade 3 Abdominal pain/cramping
|
3.1%
10/323
|
2.3%
8/345
|
|
General disorders
Grade 4 Abdominal pain/cramping
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Arrhythmia, NOS
|
3.7%
12/323
|
6.1%
21/345
|
|
Cardiac disorders
Grade 4 Arrhythmia, NOS
|
0.62%
2/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 3 Cardiac ischemia/infarction
|
0.93%
3/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 4 Cardiac ischemia/infarction
|
0.62%
2/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Cardiovascular-other
|
2.2%
7/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 4 Cardiovascular-other
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Cerebrovascular ischemia
|
2.2%
7/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 4 Cerebrovascular ischemia
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Conduction abnormality/block
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 4 Conduction abnormality/block
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Edema
|
1.9%
6/323
|
1.2%
4/345
|
|
Cardiac disorders
Grade 3 Hypertension
|
2.2%
7/323
|
2.0%
7/345
|
|
Cardiac disorders
Grade 3 Hypotension
|
2.5%
8/323
|
2.3%
8/345
|
|
Cardiac disorders
Grade 4 Hypotension
|
1.5%
5/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 LVEF decrease/CHF
|
0.00%
0/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 3 Nodal/junctional dysrhythmia
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Sinus bradycardia
|
1.9%
6/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 4 Sinus bradycardia
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Sinus tachycardia
|
0.93%
3/323
|
0.58%
2/345
|
|
Cardiac disorders
Grade 3 Supraventricular arrhythmia
|
2.2%
7/323
|
2.0%
7/345
|
|
Cardiac disorders
Grade 4 Supraventricular arrhythmia
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Surgery-injury of vein/artery
|
0.00%
0/323
|
0.29%
1/345
|
|
Cardiac disorders
Grade 3 Syncope
|
9.6%
31/323
|
3.5%
12/345
|
|
Cardiac disorders
Grade 3 Thrombosis/embolism
|
21.4%
69/323
|
13.6%
47/345
|
|
Cardiac disorders
Grade 4 Thrombosis/embolism
|
3.4%
11/323
|
0.87%
3/345
|
|
Cardiac disorders
Grade 3 Valvular heart disease
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Vasovagal episode
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Ventricular arrhythmia
|
0.62%
2/323
|
0.87%
3/345
|
|
Cardiac disorders
Grade 4 Ventricular arrhythmia
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Supra Arrhyth: Atrial Fib.
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Clotting-other
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Prothrombin time increase
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Thrombotic microangiopathy
|
0.31%
1/323
|
0.00%
0/345
|
|
Ear and labyrinth disorders
Grade 3 Hearing
|
0.31%
1/323
|
0.29%
1/345
|
|
Ear and labyrinth disorders
Grade 3 Inner ear - hearing loss
|
2.5%
8/323
|
0.00%
0/345
|
|
Ear and labyrinth disorders
Grade 3 Middle ear - hearing loss/otitis
|
0.62%
2/323
|
0.29%
1/345
|
|
Endocrine disorders
Grade 3 Diabetes
|
0.31%
1/323
|
0.29%
1/345
|
|
Endocrine disorders
Grade 3 Endocrine - other
|
0.31%
1/323
|
0.00%
0/345
|
|
Endocrine disorders
Grade 3 SIADH
|
0.00%
0/323
|
0.29%
1/345
|
|
Eye disorders
Grade 3 Blurred vision
|
0.93%
3/323
|
0.58%
2/345
|
|
Eye disorders
Grade 3 Cataract
|
3.1%
10/323
|
1.2%
4/345
|
|
Eye disorders
Grade 3 Double vision
|
0.00%
0/323
|
0.29%
1/345
|
|
Eye disorders
Grade 3 Eye - other
|
0.62%
2/323
|
0.29%
1/345
|
|
Eye disorders
Grade 3 Keratitis
|
0.00%
0/323
|
0.29%
1/345
|
|
Eye disorders
Grade 3 Photophobia
|
0.00%
0/323
|
0.29%
1/345
|
|
Eye disorders
Grade 4 Retinopathy
|
0.31%
1/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Fatigue/malaise/lethargy
|
40.2%
130/323
|
40.3%
139/345
|
|
General disorders
Grade 4 Fatigue/malaise/lethargy
|
12.4%
40/323
|
15.1%
52/345
|
|
General disorders
Grade 3 Fever without neutropenia
|
0.62%
2/323
|
2.3%
8/345
|
|
General disorders
Grade 4 Fever without neutropenia
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Fever, NOS
|
9.0%
29/323
|
7.2%
25/345
|
|
General disorders
Grade 4 Fever, NOS
|
0.62%
2/323
|
0.87%
3/345
|
|
General disorders
Grade 3 Flu-like symptoms-other
|
0.93%
3/323
|
1.2%
4/345
|
|
General disorders
Grade 3 Insomnia
|
0.31%
1/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Obesity
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Rigors/chills
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 4 Sweating
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Weight loss
|
0.31%
1/323
|
0.29%
1/345
|
|
Gastrointestinal disorders
Grade 3 Anal incontinence
|
0.31%
1/323
|
0.00%
0/345
|
|
Gastrointestinal disorders
Grade 3 Anorexia
|
29.1%
94/323
|
28.7%
99/345
|
|
Gastrointestinal disorders
Grade 4 Anorexia
|
1.9%
6/323
|
1.7%
6/345
|
|
Gastrointestinal disorders
Grade 3 Colitis
|
2.5%
8/323
|
1.4%
5/345
|
|
Gastrointestinal disorders
Grade 4 Colitis
|
0.31%
1/323
|
2.0%
7/345
|
|
Gastrointestinal disorders
Grade 3 Constipation/bowel obstruction
|
9.6%
31/323
|
4.9%
17/345
|
|
Gastrointestinal disorders
Grade 4 Constipation/bowel obstruction
|
1.9%
6/323
|
2.3%
8/345
|
|
Gastrointestinal disorders
Grade 3 Dehydration
|
1.2%
4/323
|
1.4%
5/345
|
|
Gastrointestinal disorders
Grade 3 Diarrhea with colostomy
|
0.31%
1/323
|
1.2%
4/345
|
|
Gastrointestinal disorders
Grade 3 Diarrhea without colostomy
|
18.9%
61/323
|
23.2%
80/345
|
|
Gastrointestinal disorders
Grade 4 Diarrhea without colostomy
|
2.5%
8/323
|
2.0%
7/345
|
|
Gastrointestinal disorders
Grade 3 Dyspepsia/heartburn
|
0.93%
3/323
|
0.58%
2/345
|
|
Gastrointestinal disorders
Grade 3 Esophagitis/dysphagia
|
8.0%
26/323
|
10.1%
35/345
|
|
Gastrointestinal disorders
Grade 4 Esophagitis/dysphagia
|
3.1%
10/323
|
2.0%
7/345
|
|
Gastrointestinal disorders
Grade 3 Dysphagia
|
0.31%
1/323
|
0.00%
0/345
|
|
Gastrointestinal disorders
Grade 3 GI Mucositis, NOS
|
6.2%
20/323
|
2.9%
10/345
|
|
Gastrointestinal disorders
Grade 4 GI Mucositis, NOS
|
0.00%
0/323
|
0.29%
1/345
|
|
Gastrointestinal disorders
Grade 3 GI-other
|
0.62%
2/323
|
1.7%
6/345
|
|
Gastrointestinal disorders
Grade 4 GI-other
|
0.62%
2/323
|
0.29%
1/345
|
|
Gastrointestinal disorders
Grade 3 Ileus
|
0.00%
0/323
|
0.58%
2/345
|
|
Gastrointestinal disorders
Grade 3 Mouth Dryness
|
2.2%
7/323
|
1.4%
5/345
|
|
Gastrointestinal disorders
Grade 4 Mouth Dryness
|
0.00%
0/323
|
0.29%
1/345
|
|
Gastrointestinal disorders
Grade 3 Nausea
|
36.2%
117/323
|
34.2%
118/345
|
|
Gastrointestinal disorders
Grade 4 Nausea
|
0.93%
3/323
|
1.2%
4/345
|
|
Gastrointestinal disorders
Grade 3 Pancreatitis
|
0.31%
1/323
|
0.00%
0/345
|
|
Gastrointestinal disorders
Grade 3 Periodontal
|
0.31%
1/323
|
0.00%
0/345
|
|
Gastrointestinal disorders
Grade 3 RT-GI mucositis, NOS
|
0.31%
1/323
|
0.00%
0/345
|
|
Gastrointestinal disorders
Grade 3 Stomatitis/pharyngitis
|
18.6%
60/323
|
11.9%
41/345
|
|
Gastrointestinal disorders
Grade 4 Stomatitis/pharyngitis
|
2.2%
7/323
|
3.5%
12/345
|
|
Gastrointestinal disorders
Grade 3 Vomiting
|
11.5%
37/323
|
12.2%
42/345
|
|
Gastrointestinal disorders
Grade 4 Vomiting
|
1.9%
6/323
|
2.3%
8/345
|
|
Renal and urinary disorders
Grade 3 Bladder Spasms
|
1.2%
4/323
|
0.58%
2/345
|
|
Renal and urinary disorders
Grade 4 Bladder Spasms
|
0.31%
1/323
|
0.29%
1/345
|
|
Renal and urinary disorders
Grade 3 Creatinine increase
|
3.7%
12/323
|
2.3%
8/345
|
|
Renal and urinary disorders
Grade 4 Creatinine increase
|
5.0%
16/323
|
4.3%
15/345
|
|
Renal and urinary disorders
Grade 3 GU-other
|
0.62%
2/323
|
0.29%
1/345
|
|
Renal and urinary disorders
Grade 3 incontinence
|
0.00%
0/323
|
0.29%
1/345
|
|
Renal and urinary disorders
Grade 3 Renal failure
|
1.9%
6/323
|
1.7%
6/345
|
|
Renal and urinary disorders
Grade 4 Renal failure
|
2.5%
8/323
|
1.4%
5/345
|
|
Renal and urinary disorders
Grade 3 Urinary frequency/urgency
|
0.00%
0/323
|
0.58%
2/345
|
|
Renal and urinary disorders
Grade 3 Urinary retention
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 4 Anemia (HGB)
|
8.4%
27/323
|
9.9%
34/345
|
|
Blood and lymphatic system disorders
Grade 4 Neutropenia/granulocytopenia
|
74.9%
242/323
|
75.1%
259/345
|
|
Blood and lymphatic system disorders
Grade 4 Platelet transfusion
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 4 Thrombocytopenia (PLT)
|
49.2%
159/323
|
48.7%
168/345
|
|
Blood and lymphatic system disorders
Grade 4 Leukopenia (WBC)
|
79.6%
257/323
|
80.9%
279/345
|
|
Blood and lymphatic system disorders
Grade 3 Hematuria
|
1.5%
5/323
|
1.2%
4/345
|
|
Blood and lymphatic system disorders
Grade 4 Hematuria
|
0.00%
0/323
|
0.29%
1/345
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage w/3-4 thrombocytopenia
|
11.8%
38/323
|
10.7%
37/345
|
|
Blood and lymphatic system disorders
Grade 4 Hemorrhage w/3-4 thrombocytopenia
|
1.9%
6/323
|
2.9%
10/345
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage w/o 3-4 thrombocytopenia
|
0.00%
0/323
|
0.29%
1/345
|
|
Blood and lymphatic system disorders
Grade 3 Hemorrhage-other
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 4 Vaginal bleeding
|
0.31%
1/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Petechiae/purpura
|
0.00%
0/323
|
0.29%
1/345
|
|
Blood and lymphatic system disorders
Grade 3 Melena/GI bleeding
|
1.9%
6/323
|
2.6%
9/345
|
|
Blood and lymphatic system disorders
Grade 4 Melena/GI bleeding
|
0.62%
2/323
|
0.58%
2/345
|
|
Immune system disorders
Grade 3 Allergic/hypersensitivity
|
0.00%
0/323
|
0.29%
1/345
|
|
Immune system disorders
Grade 3 Autoimmune reaction
|
1.2%
4/323
|
0.29%
1/345
|
|
Immune system disorders
Grade 4 Autoimmune reaction
|
1.2%
4/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Catheter related infection
|
3.4%
11/323
|
5.2%
18/345
|
|
Infections and infestations
Grade 3 Ear infection ANC mid ear
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Febrile neutropenia
|
19.2%
62/323
|
23.2%
80/345
|
|
Infections and infestations
Grade 4 Febrile neutropenia
|
0.00%
0/323
|
0.58%
2/345
|
|
Infections and infestations
Grade 3 GI infection 3-4 ANC abdomen
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 GI infection 3-4 ANC appendix
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 GI Infection 3-4 ANC tooth
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 GI infection ANC abdomen
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 GU infection ABC UTI
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Infection w/grade 3 or 4 Neutrophils
|
0.93%
3/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Infection w/o 3-4 Neutropenia
|
9.0%
29/323
|
11.0%
38/345
|
|
Infections and infestations
Grade 4 Infection w/o 3-4 Neutropenia
|
0.31%
1/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Infection w/3-4 Neutropenia
|
8.7%
28/323
|
7.8%
27/345
|
|
Infections and infestations
Grade 4 Infection w/3-4 Neutropenia
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Infection ANC
|
8.4%
27/323
|
7.2%
25/345
|
|
Infections and infestations
Grade 4 Infection ANC
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Lung infection 3-4 ANC
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Lung Infection ANC Bronchus
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Lung Infection ANC Lung
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Lung Infection ANC Pharynx
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Moderate
|
0.31%
1/323
|
0.58%
2/345
|
|
Infections and infestations
Grade 3 Respiratory infect w/neutrop
|
1.2%
4/323
|
0.58%
2/345
|
|
Infections and infestations
Grade 3 Muscle infection ANC Bone
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Respiratory infection w/o neutrop
|
5.3%
17/323
|
2.9%
10/345
|
|
Infections and infestations
Grade 4 Respiratory infection w/o neutrop
|
0.31%
1/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Respiratory infection ANC
|
5.6%
18/323
|
3.2%
11/345
|
|
Infections and infestations
Grade 3 Skin infection 3-4 ANC lip/perior
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Surgery-wound infection
|
0.62%
2/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 4 Surgery -wound infection
|
0.31%
1/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 3 Urinary tract infectiob w/neutrop
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Uninary tract infection w/o neutrop
|
0.31%
1/323
|
0.58%
2/345
|
|
Infections and infestations
Grade 4 Urinary tract infection w/o neutrop
|
0.00%
0/323
|
0.29%
1/345
|
|
Infections and infestations
Grade 3 Urinary tract infection ANC
|
0.62%
2/323
|
0.87%
3/345
|
|
Hepatobiliary disorders
Grade 3 Alkaline phosphatase increase
|
0.93%
3/323
|
1.2%
4/345
|
|
Hepatobiliary disorders
Grade 3 Bilirubin increase
|
2.5%
8/323
|
2.6%
9/345
|
|
Hepatobiliary disorders
Grade 4 Bilirnbin increase
|
1.2%
4/323
|
0.58%
2/345
|
|
Hepatobiliary disorders
Grade 3 Hypoalbuminemia
|
5.0%
16/323
|
5.2%
18/345
|
|
Hepatobiliary disorders
Grade 3 Liver enlargement
|
0.00%
0/323
|
0.29%
1/345
|
|
Hepatobiliary disorders
Grade 3 SGOT (AST) increase
|
2.8%
9/323
|
2.0%
7/345
|
|
Hepatobiliary disorders
Grade 4 SGOT (AST) increase
|
0.00%
0/323
|
0.87%
3/345
|
|
Hepatobiliary disorders
Grade 3 SGPT (ALT) increase
|
5.6%
18/323
|
5.5%
19/345
|
|
Hepatobiliary disorders
Grade 4 SGPT (ALT) increase
|
0.31%
1/323
|
0.29%
1/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Acute respiratory distress syndrome
|
0.31%
1/323
|
0.29%
1/345
|
|
Nervous system disorders
Grade 3 Apnea
|
0.62%
2/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 4 Apnea
|
0.31%
1/323
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Cough
|
1.9%
6/323
|
0.87%
3/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Dyspnea
|
5.6%
18/323
|
3.5%
12/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Dyspnea
|
0.93%
3/323
|
0.29%
1/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Hiccoughs
|
0.62%
2/323
|
0.58%
2/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Hypoxia
|
10.2%
33/323
|
10.7%
37/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Hypoxia
|
2.2%
7/323
|
0.87%
3/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Lung Fistula
|
0.31%
1/323
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Lung-other
|
1.9%
6/323
|
1.7%
6/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Lung-other
|
0.31%
1/323
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pleural effusions
|
1.2%
4/323
|
0.87%
3/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pneumonitis/infilitrates
|
10.8%
35/323
|
8.7%
30/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Pneumonitis/infiltrates
|
0.31%
1/323
|
1.2%
4/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pneumothorax
|
1.5%
5/323
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Pulmonary edema
|
0.31%
1/323
|
0.29%
1/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Voice charge /stridor/larynx
|
0.00%
0/323
|
0.29%
1/345
|
|
Metabolism and nutrition disorders
Grade 3 Bicarbonate decrease
|
2.5%
8/323
|
1.4%
5/345
|
|
Metabolism and nutrition disorders
Grade 4 Bicarbonate decrease
|
0.31%
1/323
|
0.29%
1/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypercalcemia
|
0.62%
2/323
|
1.2%
4/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypercalcemia
|
1.9%
6/323
|
0.58%
2/345
|
|
Metabolism and nutrition disorders
Grade 3 Hyperglycemia
|
17.6%
57/323
|
24.3%
84/345
|
|
Metabolism and nutrition disorders
Grade 4 Hyperglycemia
|
3.1%
10/323
|
2.9%
10/345
|
|
Metabolism and nutrition disorders
Grade 3 Hyperkalemia
|
3.4%
11/323
|
5.2%
18/345
|
|
Metabolism and nutrition disorders
Grade 4 Hyperkalemia
|
1.5%
5/323
|
0.87%
3/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypermagnesemia
|
4.3%
14/323
|
6.1%
21/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypermagnesemia
|
0.31%
1/323
|
0.29%
1/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypermatremia
|
0.00%
0/323
|
0.58%
2/345
|
|
Metabolism and nutrition disorders
Grade 4 Hyperuricemia
|
0.31%
1/323
|
0.00%
0/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypocalcemia
|
18.9%
61/323
|
21.7%
75/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypocalcemia
|
6.2%
20/323
|
4.9%
17/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypokalemia
|
22.3%
72/323
|
25.8%
89/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypokalemia
|
1.9%
6/323
|
0.87%
3/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypomagnesemia
|
0.00%
0/323
|
2.9%
10/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypomagnesemia
|
0.62%
2/323
|
0.00%
0/345
|
|
Metabolism and nutrition disorders
Grade 3 Hyponatremia
|
31.3%
101/323
|
27.5%
95/345
|
|
Metabolism and nutrition disorders
Grade 4 Hyponatremia
|
4.3%
14/323
|
2.3%
8/345
|
|
Metabolism and nutrition disorders
Grade 3 Hypophosphatemia
|
56.7%
183/323
|
62.0%
214/345
|
|
Metabolism and nutrition disorders
Grade 4 Hypophosphatemia
|
0.00%
0/323
|
0.87%
3/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Fracture
|
0.00%
0/323
|
0.29%
1/345
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Gait/Walking
|
0.93%
3/323
|
0.00%
0/345
|
|
Musculoskeletal and connective tissue disorders
Grade 4 Gait/Walking
|
0.31%
1/323
|
0.00%
0/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Joint, muscle, bone
|
5.9%
19/323
|
1.7%
6/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Muscle weakness
|
1.9%
6/323
|
1.4%
5/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Osteonecrosis
|
0.62%
2/323
|
0.58%
2/345
|
|
Nervous system disorders
Grade 3 Anxiety/agitation
|
2.5%
8/323
|
4.6%
16/345
|
|
Nervous system disorders
Grade 4 Anxiety/agitation
|
0.93%
3/323
|
1.4%
5/345
|
|
Nervous system disorders
Grade 3 Ataxia
|
3.1%
10/323
|
1.7%
6/345
|
|
Nervous system disorders
Grade 4 CNS ischemia
|
0.31%
1/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 3 Confusion
|
7.7%
25/323
|
6.7%
23/345
|
|
Nervous system disorders
Grade 4 Confusion
|
1.5%
5/323
|
2.3%
8/345
|
|
Nervous system disorders
Grade 3 Depression
|
9.9%
32/323
|
8.1%
28/345
|
|
Nervous system disorders
Grade 4 Depression
|
1.9%
6/323
|
1.7%
6/345
|
|
Nervous system disorders
Grade 3 Dizziness/light headedness
|
10.8%
35/323
|
4.3%
15/345
|
|
Nervous system disorders
Grade 4 Dizziness/light headedness
|
1.2%
4/323
|
0.87%
3/345
|
|
Nervous system disorders
Grade 3 Dizziness/vertigo
|
0.31%
1/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 3 Hallucinations
|
1.2%
4/323
|
0.58%
2/345
|
|
Nervous system disorders
Grade 3 Headache
|
3.4%
11/323
|
5.5%
19/345
|
|
Nervous system disorders
Grade 3 Insomnia
|
1.2%
4/323
|
1.2%
4/345
|
|
Nervous system disorders
Grade 3 Involuntary movement/restlessnes
|
0.31%
1/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 3 Mood/consciousness change
|
7.1%
23/323
|
4.9%
17/345
|
|
Nervous system disorders
Grade 4 Mood/consciousness change
|
0.62%
2/323
|
0.87%
3/345
|
|
Nervous system disorders
Grade 3 Neuro-other
|
0.93%
3/323
|
0.87%
3/345
|
|
Nervous system disorders
Grade 4 Neuro-other
|
0.00%
0/323
|
0.29%
1/345
|
|
Nervous system disorders
Grade 3 Seizures
|
0.62%
2/323
|
0.29%
1/345
|
|
Nervous system disorders
Grade 4 Seizures
|
0.00%
0/323
|
0.87%
3/345
|
|
Nervous system disorders
Grade 3 Sensory/neuropathy
|
14.2%
46/323
|
3.8%
13/345
|
|
Nervous system disorders
Grade 4 Sensory/neuropathy
|
0.31%
1/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 3 Somnolence/consciousness loss
|
12.4%
40/323
|
9.3%
32/345
|
|
Nervous system disorders
Grade 4 Somnolence/consciousness loss
|
1.2%
4/323
|
1.2%
4/345
|
|
Nervous system disorders
Grade 3 Speech impairment
|
0.00%
0/323
|
0.29%
1/345
|
|
Nervous system disorders
Grade 3 Tremor
|
9.9%
32/323
|
4.3%
15/345
|
|
General disorders
Grade 3 Arthralgia
|
1.9%
6/323
|
2.3%
8/345
|
|
General disorders
Grade 4 Arthralgia
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Bone pain
|
7.4%
24/323
|
5.2%
18/345
|
|
General disorders
Grade 4 Bone pain
|
1.2%
4/323
|
1.2%
4/345
|
|
Cardiac disorders
Grade 3 Cardiac/heart
|
0.31%
1/323
|
0.00%
0/345
|
|
Cardiac disorders
Grade 3 Chest/thorax
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Chest pain/not cardio or pleural
|
0.62%
2/323
|
1.2%
4/345
|
|
Ear and labyrinth disorders
Grade 3 Earache
|
0.62%
2/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Extremity/limb
|
0.31%
1/323
|
0.58%
2/345
|
|
Eye disorders
Grade 3 Eye
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Hepatic pain
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Hip-left
|
0.31%
1/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Lower back
|
0.31%
1/323
|
0.87%
3/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Muscle
|
0.00%
0/323
|
0.29%
1/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Myalgia
|
1.5%
5/323
|
0.58%
2/345
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Myalgia/arthralgia
|
0.00%
0/323
|
0.87%
3/345
|
|
General disorders
Grade 3 Neuropathic pain
|
0.00%
0/323
|
0.87%
3/345
|
|
General disorders
Grade 3 Pain NOS
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Pain/other
|
16.4%
53/323
|
13.6%
47/345
|
|
General disorders
Grade 4 Pain/other
|
1.2%
4/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Pelvic
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Pleuritic pain
|
0.62%
2/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Rectal/perirectal pain
|
0.31%
1/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Rib
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Tumor pain
|
0.00%
0/323
|
0.29%
1/345
|
|
General disorders
Grade 3 Upper Back
|
1.9%
6/323
|
1.2%
4/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Grade 4 Second primary
|
1.9%
6/323
|
1.7%
6/345
|
|
Reproductive system and breast disorders
Grade 3 Erectile impotence
|
0.31%
1/323
|
0.00%
0/345
|
|
Reproductive system and breast disorders
Grade 3 Female sterility
|
0.31%
1/323
|
0.00%
0/345
|
|
Reproductive system and breast disorders
Grade 3 Menses changes
|
0.31%
1/323
|
0.00%
0/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Decubitus
|
0.31%
1/323
|
0.00%
0/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Erythema multifrme/blistering
|
0.31%
1/323
|
0.00%
0/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Erythema/rash/eruption/desquamation
|
1.9%
6/323
|
1.7%
6/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Pruritis
|
0.31%
1/323
|
0.58%
2/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Rash/desquamation
|
10.5%
34/323
|
10.4%
36/345
|
|
Skin and subcutaneous tissue disorders
Grade 4 Rash/desquamation
|
2.5%
8/323
|
1.4%
5/345
|
|
Skin and subcutaneous tissue disorders
Grade 3 Skin/other
|
1.2%
4/323
|
1.2%
4/345
|
|
General disorders
Grade 3 Failure to engraft
|
0.31%
1/323
|
0.58%
2/345
|
|
General disorders
Grade 3 Stem cell infusion complication
|
0.00%
0/323
|
0.58%
2/345
|
|
General disorders
Grade 4 Stem cell infusion complication
|
0.31%
1/323
|
0.58%
2/345
|
|
General disorders
Grade 3 Syndrome/other
|
0.31%
1/323
|
0.00%
0/345
|
|
General disorders
Grade 3 Thrombosis/embolism
|
0.31%
1/323
|
0.58%
2/345
|
Other adverse events
| Measure |
Thalidomide
n=323 participants at risk
Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
|
No Thalidomide
n=345 participants at risk
Patient received no thalidomide during induction, consolidation, and maintenance therapy.
|
|---|---|---|
|
Cardiac disorders
Grade 1 Arrythmia, NOS
|
21.7%
70/323
|
25.5%
88/345
|
|
Cardiac disorders
Grade 2 Arrythmia, NOS
|
6.5%
21/323
|
8.4%
29/345
|
|
Cardiac disorders
Grade 1 Edema
|
31.3%
101/323
|
24.1%
83/345
|
|
Cardiac disorders
Grade 2 Edema
|
10.2%
33/323
|
8.1%
28/345
|
|
Cardiac disorders
Grade 1 Sinus tachycardia
|
0.00%
0/323
|
4.6%
16/345
|
|
Cardiac disorders
Grade 2 Thrombosis/embolism
|
5.3%
17/323
|
6.1%
21/345
|
|
Endocrine disorders
Grade 1 Hypothyroidism
|
6.8%
22/323
|
6.1%
21/345
|
|
Endocrine disorders
Grade 2 Hypothyroidism
|
9.3%
30/323
|
0.00%
0/345
|
|
Eye disorders
Grade 2 Blurred vision
|
16.4%
53/323
|
13.6%
47/345
|
|
Eye disorders
Grade 1 Eye - other
|
7.4%
24/323
|
0.00%
0/345
|
|
Eye disorders
Grade 1 Vision, NOS
|
5.0%
16/323
|
0.00%
0/345
|
|
General disorders
Grade 2 Fatigue/malaise/lethargy
|
24.5%
79/323
|
22.0%
76/345
|
|
General disorders
Grade 1 Fever without neutropenia
|
14.9%
48/323
|
13.0%
45/345
|
|
General disorders
Grade 2 Fever without neutropenia
|
9.9%
32/323
|
6.1%
21/345
|
|
General disorders
Grade 1 Fever, NOS
|
29.1%
94/323
|
32.5%
112/345
|
|
General disorders
Grade 2 Fever, NOS
|
22.3%
72/323
|
17.1%
59/345
|
|
General disorders
Grade 1 Flu-like symptoms-other
|
10.8%
35/323
|
7.8%
27/345
|
|
General disorders
Grade 1 Insomnia
|
6.5%
21/323
|
0.00%
0/345
|
|
General disorders
Grade 1 Rigors/chills
|
9.0%
29/323
|
4.1%
14/345
|
|
General disorders
Grade 1 sweating
|
11.5%
37/323
|
9.0%
31/345
|
|
General disorders
Grade 2 sweating
|
10.5%
34/323
|
10.4%
36/345
|
|
General disorders
Grade 1 Weight gain
|
11.1%
36/323
|
9.0%
31/345
|
|
General disorders
Grade 1 Weight loss
|
10.8%
35/323
|
10.7%
37/345
|
|
Gastrointestinal disorders
Grade 1 Anorexia
|
15.5%
50/323
|
18.0%
62/345
|
|
Gastrointestinal disorders
Grade 2 Anorexia
|
13.0%
42/323
|
12.8%
44/345
|
|
Gastrointestinal disorders
Grade 2 Colitis
|
0.00%
0/323
|
7.0%
24/345
|
|
Gastrointestinal disorders
Grade 1 Constipation/bowel obstruction
|
17.0%
55/323
|
20.0%
69/345
|
|
Gastrointestinal disorders
Grade 2 Constipation/bowel obstruction
|
44.3%
143/323
|
32.5%
112/345
|
|
Gastrointestinal disorders
Grade 1 Diarrhea without colostomy
|
15.5%
50/323
|
14.8%
51/345
|
|
Gastrointestinal disorders
Grade 2 Diarrhea without colostomy
|
36.8%
119/323
|
36.8%
127/345
|
|
Gastrointestinal disorders
Grade 1 Dyspepsia/heartburn
|
8.4%
27/323
|
5.5%
19/345
|
|
Gastrointestinal disorders
Grade 1 Esophagitis/dysphagia
|
21.7%
70/323
|
16.2%
56/345
|
|
Gastrointestinal disorders
Grade 2 Esophagitis/dysphagia
|
16.7%
54/323
|
23.5%
81/345
|
|
Gastrointestinal disorders
Grade 1 Mouth Dryness
|
16.1%
52/323
|
13.3%
46/345
|
|
Gastrointestinal disorders
Grade 2 Mouth Dryness
|
22.6%
73/323
|
13.9%
48/345
|
|
Gastrointestinal disorders
Grade 1 Nausea
|
14.2%
46/323
|
10.7%
37/345
|
|
Gastrointestinal disorders
Grade 2 Nausea
|
25.7%
83/323
|
34.2%
118/345
|
|
Gastrointestinal disorders
Grade 1 Stomatitis/pharyngitis
|
19.5%
63/323
|
19.1%
66/345
|
|
Gastrointestinal disorders
Grade 2 Stomatitis/pharyngitis
|
22.6%
73/323
|
26.1%
90/345
|
|
Gastrointestinal disorders
Grade 1 Taste Disturbance
|
0.00%
0/323
|
4.9%
17/345
|
|
Gastrointestinal disorders
Grade 1 Vomiting
|
18.0%
58/323
|
18.8%
65/345
|
|
Gastrointestinal disorders
Grade 2 Vomiting
|
32.5%
105/323
|
35.4%
122/345
|
|
Renal and urinary disorders
Grade 1 Bladder Spasms
|
0.00%
0/323
|
6.1%
21/345
|
|
Renal and urinary disorders
Grade 1 Creatinine increase
|
23.8%
77/323
|
26.4%
91/345
|
|
Renal and urinary disorders
Grade 2 Creatinine increase
|
16.4%
53/323
|
18.0%
62/345
|
|
Renal and urinary disorders
Grade 1 Urinary frequency/urgency
|
9.9%
32/323
|
6.4%
22/345
|
|
Blood and lymphatic system disorders
Grade 2 Anemia (HGB)
|
21.7%
70/323
|
22.0%
76/345
|
|
Blood and lymphatic system disorders
Grade 3 Anemia (HGB)
|
49.8%
161/323
|
50.4%
174/345
|
|
Blood and lymphatic system disorders
Grade 3 Neutropenia/ granulocytopenia
|
5.0%
16/323
|
5.8%
20/345
|
|
Blood and lymphatic system disorders
Grade 3 PRBC transfusion
|
7.7%
25/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Platelet Transfusion
|
5.0%
16/323
|
0.00%
0/345
|
|
Blood and lymphatic system disorders
Grade 3 Thrombocytopenia (PLT)
|
30.7%
99/323
|
32.5%
112/345
|
|
Blood and lymphatic system disorders
Grade 2 Hematuria
|
0.00%
0/323
|
4.6%
16/345
|
|
Blood and lymphatic system disorders
Grade 1 Hemorrhage w/3-4 thrombocytopenia
|
12.4%
40/323
|
18.3%
63/345
|
|
Immune system disorders
Grade 1 Allergic rhinitis
|
16.7%
54/323
|
12.2%
42/345
|
|
Immune system disorders
Grade 1 Autoimmune reaction
|
7.7%
25/323
|
8.1%
28/345
|
|
Infections and infestations
Grade 2 Infection w/Grade 3 or 4 Neutrophils
|
6.5%
21/323
|
0.00%
0/345
|
|
Infections and infestations
Grade 2 Infection w/o 3-4 Neutropenia
|
10.5%
34/323
|
9.6%
33/345
|
|
Infections and infestations
Grade 2 Lung Infection ANC Bronchus
|
6.2%
20/323
|
4.3%
15/345
|
|
Infections and infestations
Grade 2 Respiratory infection w/o neutrop
|
10.2%
33/323
|
13.3%
46/345
|
|
Infections and infestations
Grade 1 Respiratory infection w/o neutrop
|
5.3%
17/323
|
0.00%
0/345
|
|
Hepatobiliary disorders
Grade 1 Alkaline phosphatase increase
|
43.0%
139/323
|
43.2%
149/345
|
|
Hepatobiliary disorders
Grade 2 Alkaline phosphatase increase
|
5.3%
17/323
|
6.1%
21/345
|
|
Hepatobiliary disorders
Grade 1 Bilirubin increase
|
16.1%
52/323
|
18.0%
62/345
|
|
Hepatobiliary disorders
Grade 2 Bilirubin increase
|
8.7%
28/323
|
7.0%
24/345
|
|
Hepatobiliary disorders
Grade 1 Hypoalbuminemia
|
26.6%
86/323
|
27.0%
93/345
|
|
Hepatobiliary disorders
Grade 2 Hypoalbuminemia
|
48.0%
155/323
|
51.9%
179/345
|
|
Hepatobiliary disorders
Grade 1 SGOT (AST) increase
|
34.4%
111/323
|
35.9%
124/345
|
|
Hepatobiliary disorders
Grade 2 SGOT (AST) increase
|
7.7%
25/323
|
8.7%
30/345
|
|
Hepatobiliary disorders
Grade 1 SGPT (ALT) increase
|
40.6%
131/323
|
40.6%
140/345
|
|
Hepatobiliary disorders
Grade 2 SGPT (ALT) increase
|
12.1%
39/323
|
16.5%
57/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Cough
|
35.0%
113/323
|
29.9%
103/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Cough
|
13.9%
45/323
|
9.0%
31/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Dyspnea
|
30.0%
97/323
|
26.7%
92/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Hypoxia
|
7.4%
24/323
|
7.0%
24/345
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pneumonitis/infiltrates
|
6.2%
20/323
|
6.4%
22/345
|
|
General disorders
Grade 1 Edema-limb
|
6.8%
22/323
|
0.00%
0/345
|
|
General disorders
Grade 1 Lymphedema
|
5.0%
16/323
|
0.00%
0/345
|
|
Metabolism and nutrition disorders
Grade 1 Bicarbonate decrease
|
60.1%
194/323
|
62.9%
217/345
|
|
Metabolism and nutrition disorders
Grade 2 Bicarbonate decrease
|
8.7%
28/323
|
11.9%
41/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypercalcemia
|
10.5%
34/323
|
10.7%
37/345
|
|
Metabolism and nutrition disorders
Grade 1 Hyperglycemia
|
14.9%
48/323
|
13.9%
48/345
|
|
Metabolism and nutrition disorders
Grade 2 Hyperglycemia
|
47.1%
152/323
|
43.8%
151/345
|
|
Metabolism and nutrition disorders
Grade 1 Hyperkalemia
|
24.1%
78/323
|
23.8%
82/345
|
|
Metabolism and nutrition disorders
Grade 2 Hyperkalemia
|
9.0%
29/323
|
4.3%
15/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypermagnesemia
|
18.6%
60/323
|
15.1%
52/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypematremia
|
24.8%
80/323
|
21.4%
74/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypocalcemia
|
10.8%
35/323
|
11.9%
41/345
|
|
Metabolism and nutrition disorders
Grade 2 Hypocalcemia
|
45.2%
146/323
|
46.4%
160/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypokalemia
|
54.2%
175/323
|
52.8%
182/345
|
|
Metabolism and nutrition disorders
Grade 1 Hypomagnesemia
|
44.0%
142/323
|
45.8%
158/345
|
|
Metabolism and nutrition disorders
Grade 2 Hypomagnesemia
|
36.8%
119/323
|
33.6%
116/345
|
|
Metabolism and nutrition disorders
Grade 1 Hyponatremia
|
43.7%
141/323
|
51.9%
179/345
|
|
Metabolism and nutrition disorders
Grade 2 Hypophosphatemia
|
23.2%
75/323
|
18.8%
65/345
|
|
Metabolism and nutrition disorders
Grade 1 Joint, muscle, bone
|
13.6%
44/323
|
11.6%
40/345
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Joint, muscle, bone
|
6.8%
22/323
|
0.00%
0/345
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Muscle weakness
|
10.5%
34/323
|
6.4%
22/345
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Muscle weakness
|
4.0%
13/323
|
5.8%
20/345
|
|
Nervous system disorders
Grade 1 Anxiety/agitation
|
24.5%
79/323
|
27.0%
93/345
|
|
Nervous system disorders
Grade 2 Anxiety/agitation
|
17.0%
55/323
|
12.8%
44/345
|
|
Nervous system disorders
Grade 1 Ataxia
|
13.9%
45/323
|
7.8%
27/345
|
|
Nervous system disorders
Grade 2 Ataxia
|
8.4%
27/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 1 Confusion
|
26.0%
84/323
|
26.7%
92/345
|
|
Nervous system disorders
Grade 2 Confusion
|
13.0%
42/323
|
10.1%
35/345
|
|
Nervous system disorders
Grade 1 Depression
|
26.3%
85/323
|
29.3%
101/345
|
|
Nervous system disorders
Grade 2 Depression
|
27.6%
89/323
|
27.2%
94/345
|
|
Nervous system disorders
Grade 1 Dizziness/light headedness
|
23.5%
76/323
|
22.0%
76/345
|
|
Nervous system disorders
Grade 2 Dizziness/light headedness
|
16.4%
53/323
|
11.9%
41/345
|
|
Nervous system disorders
Grade 1 Headache
|
14.9%
48/323
|
14.8%
51/345
|
|
Nervous system disorders
Grade 2 Headache
|
11.5%
37/323
|
8.4%
29/345
|
|
Nervous system disorders
Grade 1 Insomnia
|
14.2%
46/323
|
12.2%
42/345
|
|
Nervous system disorders
Grade 2 Insomnia
|
4.6%
15/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 1 Memory loss
|
6.2%
20/323
|
0.00%
0/345
|
|
Nervous system disorders
Grade 1 Mood/consciousness change
|
15.8%
51/323
|
10.4%
36/345
|
|
Nervous system disorders
Grade 2 Mood/consciousness change
|
10.8%
35/323
|
9.0%
31/345
|
|
Nervous system disorders
Grade 1 Sensory neuropathy
|
22.3%
72/323
|
38.8%
134/345
|
|
Nervous system disorders
Grade 2 Sensory/neuropathy
|
35.6%
115/323
|
18.0%
62/345
|
|
Nervous system disorders
Grade 1 Somnolence/consciousness loss
|
23.2%
75/323
|
22.6%
78/345
|
|
Nervous system disorders
Grade 2 Somnolence/consciousness loss
|
16.1%
52/323
|
9.9%
34/345
|
|
Nervous system disorders
Grade 1 Tremor
|
19.8%
64/323
|
14.8%
51/345
|
|
Nervous system disorders
Grade 2 Tremor
|
13.9%
45/323
|
9.3%
32/345
|
|
Nervous system disorders
Grade 1 Weakness (motor neuropathy)
|
13.9%
45/323
|
15.1%
52/345
|
|
Nervous system disorders
Grade 2 Weakness (motor neuropathy)
|
23.8%
77/323
|
15.7%
54/345
|
|
General disorders
Grade 1 Abdominal pain/cramping
|
6.2%
20/323
|
7.5%
26/345
|
|
General disorders
Grade 1 Arthralgia
|
18.6%
60/323
|
17.1%
59/345
|
|
General disorders
Grade 2 Arthralgia
|
7.1%
23/323
|
7.8%
27/345
|
|
General disorders
Grade 1 Bone pain
|
23.8%
77/323
|
20.3%
70/345
|
|
General disorders
Grade 2 Bone pain
|
17.0%
55/323
|
18.8%
65/345
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Myalgia
|
12.4%
40/323
|
15.4%
53/345
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Myalgia
|
8.0%
26/323
|
4.1%
14/345
|
|
General disorders
Grade 1 Pain/other
|
16.4%
53/323
|
22.3%
77/345
|
|
General disorders
Grade 2 Pain/other
|
22.9%
74/323
|
18.0%
62/345
|
|
General disorders
Grade 1 Upper back
|
12.4%
40/323
|
7.8%
27/345
|
|
General disorders
Grade 2 Upper back
|
10.8%
35/323
|
5.5%
19/345
|
|
Skin and subcutaneous tissue disorders
Grade 2 Alopecia
|
22.6%
73/323
|
22.9%
79/345
|
|
Skin and subcutaneous tissue disorders
Grade 1 Bruising
|
7.7%
25/323
|
7.8%
27/345
|
|
Skin and subcutaneous tissue disorders
Grade 1 Dry skin
|
18.6%
60/323
|
12.5%
43/345
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dry skin
|
5.9%
19/323
|
0.00%
0/345
|
|
Skin and subcutaneous tissue disorders
Erythema/rash/eruption/desquamation
|
11.5%
37/323
|
10.7%
37/345
|
|
Skin and subcutaneous tissue disorders
Grade 2 Erythema/rash/eruption/desquamation
|
5.6%
18/323
|
3.5%
12/345
|
|
Skin and subcutaneous tissue disorders
Grade 1 Rash/desquamation
|
22.6%
73/323
|
24.9%
86/345
|
|
Skin and subcutaneous tissue disorders
Grade 2 Rash/desquamation
|
25.4%
82/323
|
27.0%
93/345
|
|
Skin and subcutaneous tissue disorders
Grade 4 Skin/other
|
6.5%
21/323
|
4.9%
17/345
|
|
General disorders
Grade 1 Stem cell infusion complication
|
0.00%
0/323
|
4.9%
17/345
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place