Trial Outcomes & Findings for Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies (NCT NCT01273766)
NCT ID: NCT01273766
Last Updated: 2018-09-07
Results Overview
Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, up to 6 months
Results posted on
2018-09-07
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Control Arm
blood tested on healthy patients
|
Correlative
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
5
|
|
Overall Study
COMPLETED
|
4
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Arm I
n=4 Participants
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Control Arm
n=7 Participants
blood tested on healthy patients
|
Correlative
n=5 Participants
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 6 monthsChanges in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
Outcome measures
| Measure |
Arm I
n=4 Participants
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Correlative
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|
|
Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
|
7.8 10^9 Neutrophils per Liter
Standard Deviation 138.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 6 monthsPopulation: Number analyzed in rows differs from overall because data was not collected on all participants.
Records will be assessed at baseline and prospectively while on study.
Outcome measures
| Measure |
Arm I
n=4 Participants
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Correlative
n=5 Participants
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Baseline : Hospitalization
|
2 Participants
|
5 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Baseline : Ventilator
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Baseline : Transfusion
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Baseline : Antibiotics
|
0 Participants
|
5 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
1 Month : Hospitalization
|
1 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
1 Month : Ventilator
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
1 Month : Transfusion
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
2 Month : Hospitalization
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
2 Month : Ventilator
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
2 Month : Transfusion
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
4 Month : Hospitalization
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
4 Month : Ventilator
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
4 Month : Transfusion
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
4 Month : Antibiotics
|
1 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
1 Month : Antibiotics
|
1 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
2 Month : Antibiotics
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
3 Month : Hospitalization
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
3 Month : Ventilator
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
3 Month : Transfusion
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
3 Month : Antibiotics
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
5 Month : Hospitalization
|
0 Participants
|
2 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
5 Month : Ventilator
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
5 Month : Transfusion
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
5 Month : Antibiotics
|
0 Participants
|
1 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
6 Month : Hospitalization
|
3 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
6 Month : Ventilator
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
6 Month : Transfusion
|
0 Participants
|
0 Participants
|
|
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
6 Month : Antibiotics
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 6 monthsRecords will be assessed at baseline and prospectively while on study.
Outcome measures
| Measure |
Arm I
n=4 Participants
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Correlative
n=5 Participants
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|
|
Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
|
2 Participants
|
5 Participants
|
Adverse Events
Arm I
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Correlative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=4 participants at risk
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Control Arm
blood tested on healthy patients
|
Correlative
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyperglycemia
|
50.0%
2/4 • Number of events 6 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyponatremia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypokalemia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
serum glutamic pyruvic transaminase
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Heartburn/dyspepsia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Confusion
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
"Distension bloating, abdominal"
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Infection Bladder
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Cystitis
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Lipase
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Lymphopenia
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Infection Sinus
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Injury, poisoning and procedural complications
Infection with normal ANC or Grade 1 or 2 neutrophils: Nose
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
Other adverse events
| Measure |
Arm I
n=4 participants at risk
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
deferasirox : Given orally
laboratory biomarker analysis : Correlative studies
enzyme-linked immunosorbent assay : Correlative studies
|
Control Arm
blood tested on healthy patients
|
Correlative
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
|
|---|---|---|---|
|
General disorders
Pain Bladder
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Amylase
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Urine color change
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Eye disorders
Dry eye syndrome
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Anal Incontinence
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
gamma-Glutamyl transpeptidase
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Glomerular filtration rate
|
50.0%
2/4 • Number of events 4 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Low WBC
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
low Platelets
|
75.0%
3/4 • Number of events 9 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Low Hemoglobin
|
100.0%
4/4 • Number of events 15 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Gastrointestinal - Other
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Alkaline phosphatase
|
75.0%
3/4 • Number of events 10 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Creatinine
|
50.0%
2/4 • Number of events 7 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Proteinuria
|
50.0%
2/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Taste alteration
|
25.0%
1/4 • Number of events 5 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Weight loss
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyperglycemia
|
100.0%
4/4 • Number of events 15 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypoglycemia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypocalcemia
|
100.0%
4/4 • Number of events 4 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypomagnesemia
|
75.0%
3/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyponatremia
|
75.0%
3/4 • Number of events 7 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypokalemia
|
25.0%
1/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypoalbuminemia
|
100.0%
4/4 • Number of events 6 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyperbilirubinemia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
serum glutamic pyruvic transaminase
|
50.0%
2/4 • Number of events 10 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 4 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pain: Head/headache
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
25.0%
1/4 • Number of events 6 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hypermagnesemia
|
50.0%
2/4 • Number of events 4 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
hyperkalemia
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Eye disorders
Ocular/Visual - Other
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Urinary frequency/urgency
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Renal/Genitourinary - Other
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Intra-operative Injury
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Musculoskeletal Soft Tissue - Other
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Dry mouth
|
75.0%
3/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Dehydration
|
50.0%
2/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pruritus/itching
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
2/4 • Number of events 5 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pain: Abdomen
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Ataxia
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Obstruction Bladder
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Lipase
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Investigations
Lymphopenia
|
50.0%
2/4 • Number of events 4 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Memory impairment
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pain: Muscle
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pain Oral cavity
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Pain: Extremity-limb
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Lung infection
|
50.0%
2/4 • Number of events 3 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
General disorders
Hyperpigmentation
|
25.0%
1/4 • Number of events 5 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
75.0%
3/4 • Number of events 11 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Eye disorders
blurred vision
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Vascular disorders
Hemorrhage GU: Urinary
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Infection Lip perioral
|
25.0%
1/4 • Number of events 1 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
|
Infections and infestations
Blood Infection with high grade neutropenia
|
25.0%
1/4 • Number of events 2 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
—
0/0 • 6 months
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
|
Additional Information
Dr. Mary Ann Knovich
Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-7973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place