Trial Outcomes & Findings for Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies (NCT NCT01564277)
NCT ID: NCT01564277
Last Updated: 2018-01-09
Results Overview
The proportion of patients able to achieve and/or maintain a uric acid level =\< 7.5mg/dL for each treatment arm.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Within 24 hours of rasburicase treatment
Results posted on
2018-01-09
Participant Flow
Participant milestones
| Measure |
Arm I (1.5mg Rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I (1.5mg Rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 16.4 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of rasburicase treatmentPopulation: All treated and eligible patients
The proportion of patients able to achieve and/or maintain a uric acid level =\< 7.5mg/dL for each treatment arm.
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Probability of Obtaining a Uric Acid Level =< 7.5mg/dL
|
0.83 proportion of participants
Interval 0.52 to 0.98
|
0.67 proportion of participants
Interval 0.35 to 0.9
|
SECONDARY outcome
Timeframe: Up to day 7Population: All treated and eligible patients
Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =\< 7.5mg/dL by treatment arm.
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to day 7Population: All treated and eligible patients
The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =\< 7.5mg/dL) and no CR (patients with uric acid level \> 7.5mg/dL).
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Baseline White Blood Cell Count by Response
Complete Response
|
62.1 cells x 10^9/L
Standard Deviation 32.3
|
29.0 cells x 10^9/L
Standard Deviation 34.0
|
|
Baseline White Blood Cell Count by Response
No Complete Response
|
13.9 cells x 10^9/L
Standard Deviation 17.1
|
33.3 cells x 10^9/L
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Up to day 7Population: All treated and eligible patients
The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7
|
12.5 days*mg/dL
Standard Deviation 9.0
|
3.5 days*mg/dL
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: up to day 7Population: All treated and eligible patients
The number of patients with any adverse events .
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Safety of Low Single-doses of Rasburicase.
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to day 6Population: All treated and eligible patients
Count of participants experiencing a doubling of serum creatinine
Outcome measures
| Measure |
Arm I (1.5mg Rasburicase)
n=12 Participants
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 Participants
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Number of Patients Experiencing a Doubling of Serum Creatinine
|
0 Participants
|
0 Participants
|
Adverse Events
Arm I (1.5mg Rasburicase)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm II (3 mg Rasburicase)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (1.5mg Rasburicase)
n=12 participants at risk
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 participants at risk
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
Other adverse events
| Measure |
Arm I (1.5mg Rasburicase)
n=12 participants at risk
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
Arm II (3 mg Rasburicase)
n=12 participants at risk
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
rasburicase: Given IV
allopurinol: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
6/12 • Number of events 38
|
33.3%
4/12 • Number of events 10
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
4/12 • Number of events 8
|
16.7%
2/12 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia
|
58.3%
7/12 • Number of events 44
|
33.3%
4/12 • Number of events 14
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
6/12 • Number of events 44
|
25.0%
3/12 • Number of events 12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
8/12 • Number of events 54
|
41.7%
5/12 • Number of events 14
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Endocrine disorders
Cushingoid
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Eye disorders
Conjunctival haemorrhage
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 2
|
16.7%
2/12 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 4
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
50.0%
6/12 • Number of events 12
|
33.3%
4/12 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
8/12 • Number of events 16
|
25.0%
3/12 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12
|
16.7%
2/12 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 6
|
16.7%
2/12 • Number of events 4
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 2
|
16.7%
2/12 • Number of events 4
|
|
General disorders
Asthenia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Fatigue
|
25.0%
3/12 • Number of events 6
|
25.0%
3/12 • Number of events 6
|
|
General disorders
Malaise
|
16.7%
2/12 • Number of events 4
|
0.00%
0/12
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Oedema
|
33.3%
4/12 • Number of events 10
|
0.00%
0/12
|
|
General disorders
Oedema peripheral
|
25.0%
3/12 • Number of events 6
|
41.7%
5/12 • Number of events 14
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Number of events 4
|
16.7%
2/12 • Number of events 6
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.3%
1/12 • Number of events 8
|
16.7%
2/12 • Number of events 6
|
|
Infections and infestations
Bacteraemia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Candidiasis
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Infections and infestations
Herpes virus infection
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Mastitis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
33.3%
4/12 • Number of events 8
|
16.7%
2/12 • Number of events 4
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis bacterial
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12
|
16.7%
2/12 • Number of events 6
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound secretion
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
3/12 • Number of events 10
|
25.0%
3/12 • Number of events 10
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 8
|
41.7%
5/12 • Number of events 10
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Number of events 4
|
25.0%
3/12 • Number of events 10
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Number of events 4
|
33.3%
4/12 • Number of events 12
|
|
Investigations
Blood creatinine
|
0.00%
0/12
|
16.7%
2/12 • Number of events 4
|
|
Investigations
Blood creatinine increased
|
25.0%
3/12 • Number of events 12
|
16.7%
2/12 • Number of events 8
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Investigations
Breath sounds
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Investigations
Haemoglobin
|
16.7%
2/12 • Number of events 6
|
16.7%
2/12 • Number of events 8
|
|
Investigations
Lymphocyte count decreased
|
41.7%
5/12 • Number of events 30
|
16.7%
2/12 • Number of events 10
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 4
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Number of events 2
|
16.7%
2/12 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12
|
25.0%
3/12 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
25.0%
3/12 • Number of events 8
|
16.7%
2/12 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/12
|
25.0%
3/12 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
8.3%
1/12 • Number of events 4
|
16.7%
2/12 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
3/12 • Number of events 6
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
58.3%
7/12 • Number of events 28
|
50.0%
6/12 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
58.3%
7/12 • Number of events 44
|
66.7%
8/12 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
3/12 • Number of events 12
|
50.0%
6/12 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
2/12 • Number of events 6
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
4/12 • Number of events 12
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Haemorrhage intracranial
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
16.7%
2/12 • Number of events 4
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 4
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/12
|
16.7%
2/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
3/12 • Number of events 6
|
16.7%
2/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
3/12 • Number of events 6
|
8.3%
1/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
25.0%
3/12 • Number of events 8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12
|
16.7%
2/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
2/12 • Number of events 4
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12
|
25.0%
3/12 • Number of events 6
|
|
Surgical and medical procedures
Catheter removal
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Vascular disorders
Embolism
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
|
Vascular disorders
Haematoma
|
8.3%
1/12 • Number of events 2
|
16.7%
2/12 • Number of events 4
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 4
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
16.7%
2/12 • Number of events 6
|
0.00%
0/12
|
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