Trial Outcomes & Findings for Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes (NCT NCT00379912)
NCT ID: NCT00379912
Last Updated: 2018-02-14
Results Overview
Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence. Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6 months
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
Arm A Azacitidine + Erythropoietin
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A Azacitidine + Erythropoietin
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Arm A Azacitidine + Erythropoietin
n=7 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
67.50 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 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
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants completing at least three cycles at the time of analysis.
Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence. Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=6 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Overall Response After Cycle 3
|
50 percentage of participants responding
Interval 15.3 to 84.7
|
33.3 percentage of participants responding
Interval 6.3 to 72.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants completing at least six cycles at the time of analysis.
Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence. Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=6 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Overall Response Rate After Six Cycles
|
33.3 percentage of participants responding
Interval 6.3 to 72.9
|
33.3 percentage of participants responding
Interval 6.3 to 72.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients receiving at least 1 dose of study medication at the time of interim analysis.
Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure.
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=6 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone
|
66.7 percentage of participants
Interval 27.1 to 93.7
|
66.4 percentage of participants
Interval 27.1 to 93.7
|
SECONDARY outcome
Timeframe: 24 monthsData for this outcome measure was not collected or analyzed due to the termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsData for this outcome measure was not collected or analyzed due to the termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis of CD34, CD71, and CD36 cells was undertaken irrespective of arm assignment.
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD34 Baseline
|
.86 cells of BM (10e^6/ML)
Standard Error .56
|
.49 cells of BM (10e^6/ML)
Standard Error .38
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD34 After Three Cycles
|
.93 cells of BM (10e^6/ML)
Standard Error .78
|
.58 cells of BM (10e^6/ML)
Standard Error .28
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD34 After Six Cycles
|
1.15 cells of BM (10e^6/ML)
Standard Error .59
|
.52 cells of BM (10e^6/ML)
Standard Error .39
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD71 at Baseline
|
18.32 cells of BM (10e^6/ML)
Standard Error 5.30
|
7.23 cells of BM (10e^6/ML)
Standard Error 3.32
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD71 After Three Cycles
|
27.31 cells of BM (10e^6/ML)
Standard Error 14.33
|
10.13 cells of BM (10e^6/ML)
Standard Error 5.85
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD71 After Six Cycles
|
35.45 cells of BM (10e^6/ML)
Standard Error 16.50
|
9.69 cells of BM (10e^6/ML)
Standard Error 7.36
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD36 at Baseline
|
11.69 cells of BM (10e^6/ML)
Standard Error 2.76
|
5.12 cells of BM (10e^6/ML)
Standard Error 1.94
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD36 after Three Cycles
|
14.33 cells of BM (10e^6/ML)
Standard Error 6.64
|
6.08 cells of BM (10e^6/ML)
Standard Error 4.27
|
|
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
CD36 after Six Cycles
|
21.35 cells of BM (10e^6/ML)
Standard Error 9.23
|
3.57 cells of BM (10e^6/ML)
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Analysis of percent apoptosis was undertaken irrespective of arm assignment and categorized between responsers and non-responders
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
% apoptosis at baseline
|
17.04 percentage of cells
Standard Error 6.04
|
31.19 percentage of cells
Standard Error 12.03
|
|
Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
% apoptosis after three cycles
|
24.70 percentage of cells
Standard Error 9.01
|
63.43 percentage of cells
Standard Error 7.72
|
|
Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
% apoptosis after six cycles
|
42.58 percentage of cells
Standard Error 11.41
|
38.10 percentage of cells
Standard Error 4.84
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Analysis of BclXL expression was undertaken irrespective of arm assignment and categorized between responsers and non-responders
Outcome measures
| Measure |
Arm A Azacitidine + Erythropoietin
n=6 Participants
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 Participants
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
BclXL Expression
BclXL Expression at baseline
|
1.0 percentage L27 mRNA
Standard Error 0.00
|
1.00 percentage L27 mRNA
Standard Error 0
|
|
BclXL Expression
BclXL Expression after three cycles
|
1.50 percentage L27 mRNA
Standard Error 0.32
|
.77 percentage L27 mRNA
Standard Error .15
|
|
BclXL Expression
BclXL Expression after six cycles
|
3.89 percentage L27 mRNA
Standard Error .99
|
1.21 percentage L27 mRNA
Standard Error .37
|
Adverse Events
Arm A Azacitidine + Erythropoietin
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm B Azacitidine
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A Azacitidine + Erythropoietin
n=7 participants at risk
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 participants at risk
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Gastrointestinal disorders
ENTERITIS (INFLAMMATION OF THE SMALL BOWEL)
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / UPPER GI NOS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
General disorders
TUMOR LYSIS SYNDROME
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
Other adverse events
| Measure |
Arm A Azacitidine + Erythropoietin
n=7 participants at risk
Azacitidine + Erythropoietin
Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
|
Arm B Azacitidine
n=8 participants at risk
Azacitidine
Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
|
|---|---|---|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ABDOMEN NOS
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / MIDDLE EAR (OTITIS MEDIA)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / URINARY TRACT NOS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE REACTION/EXTRAVASATION CHANGES
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
General disorders
INSOMNIA
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
IRON OVERLOAD
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
14.3%
1/7 • Number of events 5 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
71.4%
5/7 • Number of events 15 • The duration of study participation, up to two years
|
62.5%
5/8 • Number of events 15 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
14.3%
1/7 • Number of events 3 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
14.3%
1/7 • Number of events 2 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Hepatobiliary disorders
PAIN / GALLBLADDER
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Ear and labyrinth disorders
PAIN / MIDDLE EAR
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
General disorders
PAIN / NECK
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
General disorders
PAIN
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
PLATELETS
|
42.9%
3/7 • Number of events 12 • The duration of study participation, up to two years
|
50.0%
4/8 • Number of events 24 • The duration of study participation, up to two years
|
|
General disorders
RIGORS/CHILLS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 2 • The duration of study participation, up to two years
|
|
General disorders
SWEATING (DIAPHORESIS)
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Investigations
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
|
14.3%
1/7 • Number of events 2 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
General disorders
WEIGHT LOSS
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
0.00%
0/7 • The duration of study participation, up to two years
|
25.0%
2/8 • Number of events 2 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
ANOREXIA
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
25.0%
2/8 • Number of events 2 • The duration of study participation, up to two years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Ear and labyrinth disorders
AUDITORY/EAR
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Skin and subcutaneous tissue disorders
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
50.0%
4/8 • Number of events 5 • The duration of study participation, up to two years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
DIARRHEA
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Nervous system disorders
DIZZINESS
|
14.3%
1/7 • Number of events 1 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
57.1%
4/7 • Number of events 5 • The duration of study participation, up to two years
|
25.0%
2/8 • Number of events 2 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
28.6%
2/7 • Number of events 2 • The duration of study participation, up to two years
|
0.00%
0/8 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
57.1%
4/7 • Number of events 10 • The duration of study participation, up to two years
|
25.0%
2/8 • Number of events 4 • The duration of study participation, up to two years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 2 • The duration of study participation, up to two years
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
HEMATOMA
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
57.1%
4/7 • Number of events 15 • The duration of study participation, up to two years
|
87.5%
7/8 • Number of events 19 • The duration of study participation, up to two years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 2 • The duration of study participation, up to two years
|
|
Cardiac disorders
HYPERTENSION
|
0.00%
0/7 • The duration of study participation, up to two years
|
12.5%
1/8 • Number of events 1 • The duration of study participation, up to two years
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place