Trial Outcomes & Findings for Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma (NCT NCT00523848)
NCT ID: NCT00523848
Last Updated: 2017-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Every 3 months
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide
Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Treated With Study Therapy
|
44
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide
Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
NOT TREATED (Became ineligible)
|
2
|
|
Overall Study
Disease Progression
|
5
|
|
Overall Study
Other, unspecified
|
4
|
Baseline Characteristics
Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma
Baseline characteristics by cohort
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=40 Participants
|
|---|---|
|
Age, Continuous
|
60.13 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
|
Gender
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 3 monthsPopulation: Evaluable patients
Outcome measures
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=40 Participants
|
|---|---|
|
Overall Response Rate (Complete and Partial)
|
77.50 percentage of participants
Interval 61.55 to 89.16
|
SECONDARY outcome
Timeframe: Every 3 monthsPopulation: Evaluable patients.
Outcome measures
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=40 Participants
|
|---|---|
|
Complete Response Rate
|
22.50 percentage of participants
Interval 10.84 to 38.45
|
SECONDARY outcome
Timeframe: Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came firstOutcome measures
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=40 Participants
|
|---|---|
|
Time to Disease Progression
|
27.8 months
Interval 17.7 to 32.1
|
Adverse Events
VDT: VELCADE, Doxil and Low-dose Thalidomide
Serious events: 16 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=44 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Bradycardia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive - Grade 3
|
4.5%
2/44 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Asthenia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chills - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pain - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Pyrexia - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Pyrexia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pyrexia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Pneumococcal bacteraemia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 3
|
13.6%
6/44 • Number of events 6
|
|
Infections and infestations
Sepsis - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Lipids abnormal - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Cachexia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Failure to thrive - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Polyneuropathy - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Spinal cord compression - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 3
|
6.8%
3/44 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypertension - Grade 2
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
VDT: VELCADE, Doxil and Low-dose Thalidomide
n=44 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
18.2%
8/44 • Number of events 9
|
|
Blood and lymphatic system disorders
Anaemia - Grade 2
|
20.5%
9/44 • Number of events 9
|
|
Blood and lymphatic system disorders
Anaemia - Grade 3
|
4.5%
2/44 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 1
|
43.2%
19/44 • Number of events 22
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
25.0%
11/44 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
15.9%
7/44 • Number of events 7
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 1
|
29.5%
13/44 • Number of events 14
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 2
|
31.8%
14/44 • Number of events 15
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 3
|
25.0%
11/44 • Number of events 11
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 1
|
13.6%
6/44 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
29.5%
13/44 • Number of events 16
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 3
|
18.2%
8/44 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
15.9%
7/44 • Number of events 11
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 2
|
9.1%
4/44 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 3
|
4.5%
2/44 • Number of events 2
|
|
Cardiac disorders
Bradycardia - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Cardiac disorders
Cyanosis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Tachycardia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Blepharitis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Diplopia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Dry eye - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Eye swelling - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Eyelid ptosis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Lacrimation increased - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Meibomianitis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Vision blurred - Grade 1
|
9.1%
4/44 • Number of events 4
|
|
Eye disorders
Vision blurred - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Visual disturbance - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension - Grade 1
|
9.1%
4/44 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
61.4%
27/44 • Number of events 27
|
|
Gastrointestinal disorders
Diarrhoea - Grade 1
|
22.7%
10/44 • Number of events 12
|
|
Gastrointestinal disorders
Dry mouth - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
22.7%
10/44 • Number of events 11
|
|
Gastrointestinal disorders
Stomatitis - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
13.6%
6/44 • Number of events 6
|
|
General disorders
Asthenia - Grade 1
|
18.2%
8/44 • Number of events 8
|
|
General disorders
Asthenia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Axillary pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chest discomfort - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chest pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chills - Grade 1
|
9.1%
4/44 • Number of events 4
|
|
General disorders
Fatigue - Grade 1
|
50.0%
22/44 • Number of events 24
|
|
General disorders
Fatigue - Grade 2
|
13.6%
6/44 • Number of events 7
|
|
General disorders
Fatigue - Grade 3
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Feeling hot - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Gait disturbance - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Gait disturbance - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Influenza like illness - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Non-cardiac chest pain - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Oedema - Grade 1
|
11.4%
5/44 • Number of events 5
|
|
General disorders
Oedema - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 1
|
31.8%
14/44 • Number of events 15
|
|
General disorders
Oedema peripheral - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Pain - Grade 1
|
9.1%
4/44 • Number of events 4
|
|
General disorders
Pain - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pyrexia - Grade 1
|
18.2%
8/44 • Number of events 8
|
|
General disorders
Tenderness - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Xerosis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Immune system disorders
Hypersensitivity - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Bacterial infection - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Breast cellulitis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Cystitis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Eye infection - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Fungal infection - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Furuncle - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Hordeolum - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Infection - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Infections and infestations
Lobar pneumonia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Localised infection - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Infections and infestations
Oral candidiasis - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Infections and infestations
Oral candidiasis - Grade 2
|
2.3%
1/44 • Number of events 2
|
|
Infections and infestations
Pneumonia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 2
|
9.1%
4/44 • Number of events 5
|
|
Infections and infestations
Pneumonia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Rash pustular - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Sinusitis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Tinea cruris - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Tinea infection - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Tinea pedis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open wound - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased - Grade 1
|
11.4%
5/44 • Number of events 5
|
|
Investigations
Alanine aminotransferase increased - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased - Grade 1
|
31.8%
14/44 • Number of events 14
|
|
Investigations
Aspartate aminotransferase increased - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased - Grade 1
|
20.5%
9/44 • Number of events 11
|
|
Investigations
Blood creatine increased - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Blood creatine increased - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Heart rate decreased - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Heart rate decreased - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Investigations
International normalised ratio increased - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Weight decreased - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Weight decreased - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Weight decreased - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Weight increased - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
25.0%
11/44 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 1
|
29.5%
13/44 • Number of events 13
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 2
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 3
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 1
|
20.5%
9/44 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 1
|
18.2%
8/44 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
9.1%
4/44 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 1
|
25.0%
11/44 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 1
|
18.2%
8/44 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 1
|
13.6%
6/44 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 1
|
20.5%
9/44 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Oral intake reduced - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1
|
6.8%
3/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
13.6%
6/44 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 2
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 3
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Amnesia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Balance disorder - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Burning sensation - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Cluster headache - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness - Grade 1
|
38.6%
17/44 • Number of events 22
|
|
Nervous system disorders
Dizziness - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Dysgeusia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache - Grade 1
|
4.5%
2/44 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia - Grade 1
|
4.5%
2/44 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Grade 1
|
6.8%
3/44 • Number of events 4
|
|
Nervous system disorders
Neuropathy - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral - Grade 1
|
25.0%
11/44 • Number of events 11
|
|
Nervous system disorders
Neuropathy peripheral - Grade 2
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Neuropathy peripheral - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Paraesthesia - Grade 1
|
9.1%
4/44 • Number of events 4
|
|
Nervous system disorders
Parosmia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Tremor - Grade 1
|
11.4%
5/44 • Number of events 5
|
|
Psychiatric disorders
Anxiety - Grade 1
|
2.3%
1/44 • Number of events 2
|
|
Psychiatric disorders
Confusional state - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Confusional state - Grade 4
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Illusion - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Insomnia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Nervousness - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Panic attack - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Dysuria - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Polyuria - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Renal tubular acidosis - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
22.7%
10/44 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 1
|
25.0%
11/44 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional - Grade 1
|
11.4%
5/44 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug eruption - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Drug eruption - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin - Grade 1
|
22.7%
10/44 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Dry skin - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema - Grade 1
|
13.6%
6/44 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome - Grade 3
|
6.8%
3/44 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder - Grade 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
22.7%
10/44 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous - Grade 1
|
13.6%
6/44 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash erythematous - Grade 2
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin atrophy - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin discolouration - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation - Grade 1
|
6.8%
3/44 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis - Grade 3
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypertension - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 2
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 2
|
4.5%
2/44 • Number of events 2
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place