Trial Outcomes & Findings for BMS 247550 to Treat Kidney Cancer (NCT NCT00030992)
NCT ID: NCT00030992
Last Updated: 2012-08-20
Results Overview
Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
6 weeks
Results posted on
2012-08-20
Participant Flow
102 participants were enrolled in this study.
Participant milestones
| Measure |
BMS-247550
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMS 247550 to Treat Kidney Cancer
Baseline characteristics by cohort
| Measure |
BMS-247550
n=102 Participants
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age Continuous
|
57.21 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksResponse rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
BMS-247550
n=102 Participants
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
Response Rate
Complete response
|
1 Percentage of participants
|
|
Response Rate
Partial Response
|
9.4 Percentage of participants
|
|
Response Rate
Progressive disease
|
12.6 Percentage of participants
|
|
Response Rate
Stable disease
|
76.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 10 yearsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
BMS-247550
n=102 Participants
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
Number of Participants With Adverse Events
|
99 Participants
|
Adverse Events
BMS-247550
Serious events: 40 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BMS-247550
n=102 participants at risk
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Alkaline phosphatase
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Cardiac left ventricular function
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Cardiac troponin T (cTnT)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Catheter-related infection
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Circulatory or cardiac-Other (hypertension)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
CNS cerebrovascular ischemia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
CPK (creatine phosphokinase)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Creatinine
|
2.0%
2/102 • Number of events 3 • 10 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
6/102 • Number of events 6 • 10 years
|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
4.9%
5/102 • Number of events 5 • 10 years
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.9%
6/102 • Number of events 6 • 10 years
|
|
General disorders
Edema
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
2.9%
3/102 • Number of events 4 • 10 years
|
|
Blood and lymphatic system disorders
Hemoglobin (hgb)
|
3.9%
4/102 • Number of events 4 • 10 years
|
|
Investigations
Hemoglobin increased
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding associated with surgery
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Vascular disorders
Hypotension
|
5.9%
6/102 • Number of events 6 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Infection
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Infections and infestations
Infection with neutropenia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Infection without neutropenia
|
6.9%
7/102 • Number of events 7 • 10 years
|
|
Infections and infestations
Infection, Other (other than fever with neutropenia)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, or bone (osseous)-Other (fracture)
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Nervous system disorders
Neurologic-Other (autonomic neuropathy)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Nervous system disorders
Neuropathic pain
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Nervous system disorders
Neuropathy-motor
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
4.9%
5/102 • Number of events 5 • 10 years
|
|
Nervous system disorders
Pain-neuropathic
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Platelet count decreased
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Pericardial effusion/pericarditis
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other: malignant pleural effusion
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Seizure(s)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
SGOT (AST)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
SGPT (ALT)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Syncope
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Vascular disorders
Thrombosis/embolism
|
0.98%
1/102 • Number of events 3 • 10 years
|
|
Nervous system disorders
Vasovagal reaction
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Weight loss
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Fever
|
7.8%
8/102 • Number of events 8 • 10 years
|
Other adverse events
| Measure |
BMS-247550
n=102 participants at risk
One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2
|
|---|---|
|
General disorders
Fatigue
|
12.7%
13/102 • Number of events 32 • 10 years
|
|
Nervous system disorders
Neuropathy-motor
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
59.8%
61/102 • Number of events 76 • 10 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
11.8%
12/102 • Number of events 19 • 10 years
|
|
Metabolism and nutrition disorders
Acidosis
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.9%
4/102 • Number of events 12 • 10 years
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
3/102 • Number of events 5 • 10 years
|
|
Investigations
Alkaline phosphokinase
|
23.5%
24/102 • Number of events 33 • 10 years
|
|
Investigations
Alkaline phosphokinase increased
|
3.9%
4/102 • Number of events 6 • 10 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
11.8%
12/102 • Number of events 16 • 10 years
|
|
Immune system disorders
Allergic rhinitis
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
14.7%
15/102 • Number of events 19 • 10 years
|
|
Investigations
Allergy-Other (rhinitis)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Amylase
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
12/102 • Number of events 52 • 10 years
|
|
Metabolism and nutrition disorders
Anorexia
|
54.9%
56/102 • Number of events 88 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
30.4%
31/102 • Number of events 49 • 10 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
6/102 • Number of events 13 • 10 years
|
|
Hepatobiliary disorders
Bilirubin
|
5.9%
6/102 • Number of events 10 • 10 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other, specify (bruising)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
3.9%
4/102 • Number of events 8 • 10 years
|
|
Eye disorders
Blurred vision
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Cardiac troponin I increased
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Catheter-related infection
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
6.9%
7/102 • Number of events 9 • 10 years
|
|
General disorders
Chills
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Investigations
Cholesterol high
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Cardiac disorders
Circulatory or cardiac-Other (edema)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Psychiatric disorders
Confusion
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Eye disorders
Conjunctivitis
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Constipation
|
29.4%
30/102 • Number of events 40 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.4%
29/102 • Number of events 39 • 10 years
|
|
Investigations
CPK (creatine phosphokinase)
|
3.9%
4/102 • Number of events 5 • 10 years
|
|
Investigations
CPK increased
|
2.0%
2/102 • Number of events 4 • 10 years
|
|
Investigations
Creatinine
|
14.7%
15/102 • Number of events 21 • 10 years
|
|
Investigations
Creatinine increased
|
4.9%
5/102 • Number of events 14 • 10 years
|
|
Metabolism and nutrition disorders
Dehydration
|
15.7%
16/102 • Number of events 22 • 10 years
|
|
Gastrointestinal disorders
Depressed level of consciousness
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis, focal
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
4/102 • Number of events 4 • 10 years
|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
41.2%
42/102 • Number of events 95 • 10 years
|
|
Nervous system disorders
Dizziness
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Nervous system disorders
Dizziness/lightheadedness
|
7.8%
8/102 • Number of events 9 • 10 years
|
|
Eye disorders
Dry eye
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Nervous system disorders
Dysgeusia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
6.9%
7/102 • Number of events 7 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
5/102 • Number of events 8 • 10 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other, specify (tinnitus)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Edema
|
13.7%
14/102 • Number of events 19 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
6/102 • Number of events 9 • 10 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Ear and labyrinth disorders
External auditory canal
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
2.9%
3/102 • Number of events 4 • 10 years
|
|
Eye disorders
Eye disorders-Other, specify (blepharitis)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
71.6%
73/102 • Number of events 220 • 10 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Fever
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
General disorders
Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)
|
29.4%
30/102 • Number of events 35 • 10 years
|
|
Vascular disorders
Flushing
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
GI-Other (bloating)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Nervous system disorders
Headache
|
14.7%
15/102 • Number of events 21 • 10 years
|
|
Renal and urinary disorders
Hematuria
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
5.9%
6/102 • Number of events 9 • 10 years
|
|
Blood and lymphatic system disorders
Hemoglobin (hgb)
|
63.7%
65/102 • Number of events 235 • 10 years
|
|
Investigations
Hemoglobin increased
|
0.98%
1/102 • Number of events 10 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
4.9%
5/102 • Number of events 6 • 10 years
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding associated with surgery
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Vascular disorders
Hot flashes/flashes
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.8%
12/102 • Number of events 18 • 10 years
|
|
Investigations
Hypercholesterolemia
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
17/102 • Number of events 28 • 10 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.7%
15/102 • Number of events 24 • 10 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
6/102 • Number of events 9 • 10 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.8%
10/102 • Number of events 13 • 10 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.8%
9/102 • Number of events 13 • 10 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
60.8%
62/102 • Number of events 113 • 10 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
12/102 • Number of events 22 • 10 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.8%
9/102 • Number of events 15 • 10 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.6%
19/102 • Number of events 45 • 10 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
18/102 • Number of events 37 • 10 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.8%
8/102 • Number of events 10 • 10 years
|
|
Vascular disorders
Hypotension
|
5.9%
6/102 • Number of events 7 • 10 years
|
|
Renal and urinary disorders
Incontinence
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Infections and infestations
Infection without neutropenia
|
29.4%
30/102 • Number of events 41 • 10 years
|
|
Infections and infestations
Infection, Other (skin)
|
7.8%
8/102 • Number of events 8 • 10 years
|
|
Infections and infestations
Infections and infestations-Other, specify (skin)
|
3.9%
4/102 • Number of events 5 • 10 years
|
|
Investigations
INR increased
|
3.9%
4/102 • Number of events 6 • 10 years
|
|
Psychiatric disorders
Insomnia
|
12.7%
13/102 • Number of events 15 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, or bone (osseous)-Other (myalgia)
|
3.9%
4/102 • Number of events 4 • 10 years
|
|
Investigations
Leukocytes (total WBC)
|
33.3%
34/102 • Number of events 96 • 10 years
|
|
Nervous system disorders
Leukoencephalopathy
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Lymphocyte count decreased
|
6.9%
7/102 • Number of events 30 • 10 years
|
|
Investigations
Lymphocyte count increased
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Memory loss
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Ear and labyrinth disorders
Middle ear/hearing
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Psychiatric disorders
Mood alteration-anxiety agitation
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Psychiatric disorders
Mood alteration-depression
|
7.8%
8/102 • Number of events 10 • 10 years
|
|
Psychiatric disorders
Mood alteration-euphoria
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
3.9%
4/102 • Number of events 5 • 10 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle ache)
|
13.7%
14/102 • Number of events 21 • 10 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
36.3%
37/102 • Number of events 47 • 10 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Gastrointestinal disorders
Nausea
|
47.1%
48/102 • Number of events 132 • 10 years
|
|
Nervous system disorders
Nervous system disorders-Other, specify (vasovagal)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Neurologic-Other (dizziness)
|
2.9%
3/102 • Number of events 3 • 10 years
|
|
Nervous system disorders
Neuropathic pain
|
5.9%
6/102 • Number of events 9 • 10 years
|
|
Nervous system disorders
Neuropathy-sensory
|
49.0%
50/102 • Number of events 88 • 10 years
|
|
Investigations
Neutrophil count decreased
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
45.1%
46/102 • Number of events 142 • 10 years
|
|
Eye disorders
Ocular-Other (blurred vision)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Pain
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
General disorders
Pain-Other (dysethesia)
|
16.7%
17/102 • Number of events 23 • 10 years
|
|
Cardiac disorders
Palpitation
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
Partial thromboplastin time (PTT)
|
9.8%
10/102 • Number of events 14 • 10 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
5/102 • Number of events 5 • 10 years
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Vascular disorders
Phlebitis (superficial)
|
3.9%
4/102 • Number of events 4 • 10 years
|
|
Investigations
Platelet count decreased
|
2.9%
3/102 • Number of events 6 • 10 years
|
|
Investigations
Platelets
|
26.5%
27/102 • Number of events 72 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion/pericarditis
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Renal and urinary disorders
Proteinuria
|
10.8%
11/102 • Number of events 11 • 10 years
|
|
Vascular disorders
Prothrombin time (PT)
|
4.9%
5/102 • Number of events 5 • 10 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.8%
12/102 • Number of events 13 • 10 years
|
|
Renal and urinary disorders
Renal/GU-Other (urgency)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
General disorders
Rigors, chills
|
8.8%
9/102 • Number of events 10 • 10 years
|
|
Gastrointestinal disorders
Salivary gland changes
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Nervous system disorders
Sense of smell
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Investigations
SGOT (AST)
|
28.4%
29/102 • Number of events 48 • 10 years
|
|
Investigations
SGPT (ALT)
|
18.6%
19/102 • Number of events 31 • 10 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Skin and subcutaneous tissue disorders
Skin-Other (dry skin)
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Infections and infestations
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
9.8%
10/102 • Number of events 10 • 10 years
|
|
Infections and infestations
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
|
8.8%
9/102 • Number of events 10 • 10 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.9%
5/102 • Number of events 6 • 10 years
|
|
Nervous system disorders
Syncope
|
2.0%
2/102 • Number of events 2 • 10 years
|
|
Nervous system disorders
Taste disturbance (dysgeusia)
|
39.2%
40/102 • Number of events 86 • 10 years
|
|
Eye disorders
Tearing (watery eyes)
|
2.9%
3/102 • Number of events 4 • 10 years
|
|
Vascular disorders
Thromboembolic event
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Vascular disorders
Thrombosis/embolism
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Blood and lymphatic system disorders
Transfusion:pRBCs
|
2.0%
2/102 • Number of events 3 • 10 years
|
|
Nervous system disorders
Tremor
|
2.0%
2/102 • Number of events 3 • 10 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.9%
3/102 • Number of events 6 • 10 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Renal and urinary disorders
Urinary retention
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
2.0%
2/102 • Number of events 3 • 10 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Eye disorders
Vision-blurred vision
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx
|
0.98%
1/102 • Number of events 2 • 10 years
|
|
Gastrointestinal disorders
Vomiting
|
36.3%
37/102 • Number of events 66 • 10 years
|
|
Investigations
Weight loss
|
16.7%
17/102 • Number of events 20 • 10 years
|
|
Investigations
White blood cell decreased
|
4.9%
5/102 • Number of events 15 • 10 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Wound-infectious
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Wound-non-infectious
|
0.98%
1/102 • Number of events 1 • 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.6%
19/102 • Number of events 22 • 10 years
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • Number of events 4 • 10 years
|
Additional Information
Tito Fojo, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-2631
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place