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Trial record 1 of 1 for:    NCT01420926
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Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01420926
Recruitment Status : Active, not recruiting
First Posted : August 22, 2011
Results First Posted : October 24, 2016
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Therapy-Related Acute Myeloid Leukemia
Interventions Drug: Bortezomib
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Enrollment 165
Recruitment Details 165 participants were enrolled from 24 sites from November 2011 to March 2013
Pre-assignment Details Two (2) participants never received any protocol treatment; per study design these patients were excluded from all analyses.
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
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REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 82 81
Completed 22 16
Not Completed 60 65
Reason Not Completed
Adverse Event             6             4
Death             18             17
Withdrawal by Subject             11             16
Non-protocol treatment             17             20
Physician Decision             7             5
Continues on active treatment             1             3
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib) Total
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REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Total of all reporting groups
Overall Number of Baseline Participants 82 81 163
Hide Baseline Analysis Population Description
Two (2) participants never received any protocol treatment; per study design these patients were excluded from all analyses.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 82 participants 81 participants 163 participants
72.4
(60.7 to 92.3)
72.9
(60.5 to 90)
72.4
(60.5 to 92.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Female
31
  37.8%
19
  23.5%
50
  30.7%
Male
51
  62.2%
62
  76.5%
113
  69.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
77
  93.9%
77
  95.1%
154
  94.5%
Unknown or Not Reported
5
   6.1%
4
   4.9%
9
   5.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.2%
1
   0.6%
Native Hawaiian or Other Pacific Islander
1
   1.2%
0
   0.0%
1
   0.6%
Black or African American
3
   3.7%
4
   4.9%
7
   4.3%
White
74
  90.2%
73
  90.1%
147
  90.2%
More than one race
0
   0.0%
1
   1.2%
1
   0.6%
Unknown or Not Reported
4
   4.9%
2
   2.5%
6
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 81 participants 163 participants
82 81 163
1.Primary Outcome
Title Overall Survival (OS) Time
Hide Description Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Time from study entry to death assessed up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 82 81
Median (95% Confidence Interval)
Unit of Measure: months
9.3
(5.8 to 12.2)
8.8
(3.8 to 14.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Decitabine), Arm II (Decitabine and Bortezomib)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Stratified 1-sided log-rank
Comments [Not Specified]
2.Secondary Outcome
Title Complete Remission Rate (CR and CRi)
Hide Description Defined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: <5% marrow blast, > 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC >1,000/mm^3 and platelets > 100,000/mm^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC < 1,000/mm^3 or platelets < 100,000/mm^3.
Time Frame Duration of study up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 82 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(30 to 52)
38
(28 to 50)
3.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or >= 5% marrow blasts after achieving a CR or CRi.
Time Frame Time from study entry to relapse and/or death (up to 10 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants who achieved a CR are included in this analysis.
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 15 17
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(3.9 to 21.3)
15.3
(7.9 to 25.5)
4.Secondary Outcome
Title Progression-free Survival
Hide Description Progression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Time from study entry to progression and/or death (up to 10 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 82 81
Median (95% Confidence Interval)
Unit of Measure: months
7.3
(5.3 to 8.9)
8.0
(3.8 to 12.2)
5.Secondary Outcome
Title Adverse Events
Hide Description Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
Time Frame Duration of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 4 participants were not evaluated for adverse events were excluded from this analysis.
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: participants
51 45
Time Frame [Not Specified]
Adverse Event Reporting Description 159 participants were evaluable for adverse events.
 
Arm/Group Title Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Hide Arm/Group Description

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.

CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

All-Cause Mortality
Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/80 (53.75%)      45/79 (56.96%)    
Blood and lymphatic system disorders     
Anemia  1  40/80 (50.00%)  51 39/79 (49.37%)  52
Blood and lymphatic system disorders  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Disseminated intravascular coagulation  1  2/80 (2.50%)  4 3/79 (3.80%)  3
Febrile neutropenia  1  20/80 (25.00%)  23 23/79 (29.11%)  24
Thrombotic thrombocytopenic purpura  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Cardiac disorders     
Acute coronary syndrome  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Atrial fibrillation  1  8/80 (10.00%)  9 2/79 (2.53%)  2
Atrial flutter  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Cardiac arrest  1  1/80 (1.25%)  1 3/79 (3.80%)  3
Cardiac disorders - Other  1  3/80 (3.75%)  4 3/79 (3.80%)  3
Chest pain - cardiac  1  2/80 (2.50%)  2 2/79 (2.53%)  3
Conduction disorder  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Heart failure  1  2/80 (2.50%)  2 3/79 (3.80%)  3
Left ventricular systolic dysfunction  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Myocardial infarction  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Palpitations  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Paroxysmal atrial tachycardia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pericardial effusion  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Pericardial tamponade  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Sinus bradycardia  1  2/80 (2.50%)  3 1/79 (1.27%)  1
Sinus tachycardia  1  9/80 (11.25%)  12 7/79 (8.86%)  10
Supraventricular tachycardia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Ventricular arrhythmia  1  3/80 (3.75%)  6 4/79 (5.06%)  4
Ventricular fibrillation  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Ventricular tachycardia  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Congenital, familial and genetic disorders     
Congenital, familial and genetic disorders - Other  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Ear and labyrinth disorders     
Ear pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Eye disorders     
Blurred vision  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Eye disorders - Other  1  1/80 (1.25%)  2 0/79 (0.00%)  0
Eye pain  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Floaters  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Watering eyes  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Gastrointestinal disorders     
Abdominal distension  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Abdominal pain  1  10/80 (12.50%)  10 4/79 (5.06%)  4
Anal pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Ascites  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Bloating  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Colitis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Colonic fistula  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Colonic perforation  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Constipation  1  17/80 (21.25%)  20 16/79 (20.25%)  19
Diarrhea  1  14/80 (17.50%)  17 22/79 (27.85%)  24
Dry mouth  1  4/80 (5.00%)  4 4/79 (5.06%)  4
Dyspepsia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Dysphagia  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Enterocolitis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Esophageal pain  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Fecal incontinence  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Flatulence  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Gastric hemorrhage  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Gastroesophageal reflux disease  1  7/80 (8.75%)  9 2/79 (2.53%)  2
Gastrointestinal disorders - Other  1  3/80 (3.75%)  4 5/79 (6.33%)  7
Hemorrhoidal hemorrhage  1  1/80 (1.25%)  1 3/79 (3.80%)  3
Hemorrhoids  1  5/80 (6.25%)  5 2/79 (2.53%)  3
Ileus  1  1/80 (1.25%)  1 3/79 (3.80%)  3
Intra-abdominal hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Lip pain  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Mucositis oral  1  5/80 (6.25%)  5 7/79 (8.86%)  7
Nausea  1  21/80 (26.25%)  25 21/79 (26.58%)  24
Oral hemorrhage  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Oral pain  1  2/80 (2.50%)  2 4/79 (5.06%)  4
Periodontal disease  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Small intestinal obstruction  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Toothache  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Typhlitis  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Vomiting  1  16/80 (20.00%)  18 14/79 (17.72%)  17
General disorders     
Chills  1  9/80 (11.25%)  11 8/79 (10.13%)  9
Death NOS  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Edema face  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Edema limbs  1  17/80 (21.25%)  19 23/79 (29.11%)  28
Edema trunk  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Fatigue  1  29/80 (36.25%)  38 27/79 (34.18%)  35
Fever  1  7/80 (8.75%)  10 9/79 (11.39%)  12
Flu like symptoms  1  0/80 (0.00%)  0 1/79 (1.27%)  1
General disorders and administration site conditions - Other  1  3/80 (3.75%)  3 3/79 (3.80%)  3
Hypothermia  1  0/80 (0.00%)  0 3/79 (3.80%)  3
Infusion related reaction  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Injection site reaction  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Localized edema  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Malaise  1  3/80 (3.75%)  4 2/79 (2.53%)  3
Multi-organ failure  1  3/80 (3.75%)  4 1/79 (1.27%)  1
Non-cardiac chest pain  1  4/80 (5.00%)  4 6/79 (7.59%)  8
Pain  1  8/80 (10.00%)  8 8/79 (10.13%)  9
Hepatobiliary disorders     
Hepatic failure  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hepatobiliary disorders - Other  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Immune system disorders     
Allergic reaction  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Infections and infestations     
Abdominal infection  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Catheter related infection  1  1/80 (1.25%)  2 5/79 (6.33%)  5
Cecal infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Enterocolitis infectious  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Esophageal infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Eye infection  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Gum infection  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Infections and infestations - Other  1  8/80 (10.00%)  9 11/79 (13.92%)  11
Joint infection  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Lip infection  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Lung infection  1  14/80 (17.50%)  18 13/79 (16.46%)  16
Mucosal infection  1  3/80 (3.75%)  5 2/79 (2.53%)  2
Papulopustular rash  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Penile infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pharyngitis  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Pleural infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Sepsis  1  12/80 (15.00%)  13 9/79 (11.39%)  9
Sinusitis  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Skin infection  1  5/80 (6.25%)  5 4/79 (5.06%)  4
Tooth infection  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Upper respiratory infection  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Urinary tract infection  1  3/80 (3.75%)  3 3/79 (3.80%)  3
Wound infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  8/80 (10.00%)  8 4/79 (5.06%)  4
Fall  1  6/80 (7.50%)  7 4/79 (5.06%)  4
Fracture  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Injury, poisoning and procedural complications - Other  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Wound dehiscence  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  6/80 (7.50%)  6 8/79 (10.13%)  8
Alanine aminotransferase increased  1  13/80 (16.25%)  15 15/79 (18.99%)  19
Alkaline phosphatase increased  1  8/80 (10.00%)  11 12/79 (15.19%)  14
Aspartate aminotransferase increased  1  15/80 (18.75%)  17 20/79 (25.32%)  22
Blood bilirubin increased  1  21/80 (26.25%)  24 10/79 (12.66%)  10
Cardiac troponin I increased  1  1/80 (1.25%)  1 4/79 (5.06%)  4
Cholesterol high  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Creatinine increased  1  17/80 (21.25%)  17 19/79 (24.05%)  26
Ejection fraction decreased  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Electrocardiogram QT corrected interval prolonged  1  6/80 (7.50%)  7 6/79 (7.59%)  6
GGT increased  1  0/80 (0.00%)  0 1/79 (1.27%)  1
INR increased  1  5/80 (6.25%)  5 7/79 (8.86%)  7
Investigations - Other  1  1/80 (1.25%)  1 5/79 (6.33%)  5
Lipase increased  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Lymphocyte count decreased  1  14/80 (17.50%)  18 17/79 (21.52%)  25
Lymphocyte count increased  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Neutrophil count decreased  1  37/80 (46.25%)  47 38/79 (48.10%)  51
Platelet count decreased  1  39/80 (48.75%)  47 37/79 (46.84%)  48
Urine output decreased  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Weight gain  1  4/80 (5.00%)  5 5/79 (6.33%)  6
Weight loss  1  7/80 (8.75%)  12 8/79 (10.13%)  12
White blood cell decreased  1  20/80 (25.00%)  27 18/79 (22.78%)  25
Metabolism and nutrition disorders     
Acidosis  1  2/80 (2.50%)  2 5/79 (6.33%)  5
Alkalosis  1  2/80 (2.50%)  3 1/79 (1.27%)  1
Anorexia  1  16/80 (20.00%)  21 18/79 (22.78%)  24
Dehydration  1  4/80 (5.00%)  4 4/79 (5.06%)  4
Hypercalcemia  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hyperglycemia  1  24/80 (30.00%)  33 25/79 (31.65%)  33
Hyperkalemia  1  4/80 (5.00%)  6 4/79 (5.06%)  4
Hypermagnesemia  1  5/80 (6.25%)  7 4/79 (5.06%)  4
Hypernatremia  1  4/80 (5.00%)  4 1/79 (1.27%)  1
Hypertriglyceridemia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hyperuricemia  1  0/80 (0.00%)  0 3/79 (3.80%)  3
Hypoalbuminemia  1  21/80 (26.25%)  28 26/79 (32.91%)  32
Hypocalcemia  1  19/80 (23.75%)  21 19/79 (24.05%)  23
Hypoglycemia  1  1/80 (1.25%)  1 7/79 (8.86%)  7
Hypokalemia  1  17/80 (21.25%)  24 21/79 (26.58%)  29
Hypomagnesemia  1  16/80 (20.00%)  21 7/79 (8.86%)  8
Hyponatremia  1  20/80 (25.00%)  25 19/79 (24.05%)  22
Hypophosphatemia  1  8/80 (10.00%)  11 8/79 (10.13%)  9
Iron overload  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Metabolism and nutrition disorders - Other  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Tumor lysis syndrome  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/80 (7.50%)  7 2/79 (2.53%)  2
Arthritis  1  1/80 (1.25%)  2 2/79 (2.53%)  3
Back pain  1  7/80 (8.75%)  7 7/79 (8.86%)  7
Bone pain  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Buttock pain  1  1/80 (1.25%)  2 0/79 (0.00%)  0
Chest wall pain  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Flank pain  1  1/80 (1.25%)  2 1/79 (1.27%)  1
Generalized muscle weakness  1  11/80 (13.75%)  16 9/79 (11.39%)  14
Joint effusion  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Muscle weakness upper limb  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Musculoskeletal and connective tissue disorder - Other  1  1/80 (1.25%)  1 5/79 (6.33%)  5
Myalgia  1  3/80 (3.75%)  3 1/79 (1.27%)  1
Neck pain  1  1/80 (1.25%)  2 1/79 (1.27%)  1
Pain in extremity  1  6/80 (7.50%)  7 8/79 (10.13%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  3/80 (3.75%)  4 4/79 (5.06%)  6
Treatment related secondary malignancy  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Nervous system disorders     
Ataxia  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Cognitive disturbance  1  1/80 (1.25%)  4 0/79 (0.00%)  0
Dizziness  1  9/80 (11.25%)  10 10/79 (12.66%)  11
Dysarthria  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Dysgeusia  1  2/80 (2.50%)  3 4/79 (5.06%)  5
Dysphasia  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Headache  1  6/80 (7.50%)  7 11/79 (13.92%)  12
Intracranial hemorrhage  1  1/80 (1.25%)  1 3/79 (3.80%)  3
Lethargy  1  4/80 (5.00%)  5 2/79 (2.53%)  2
Memory impairment  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Nervous system disorders - Other  1  4/80 (5.00%)  4 4/79 (5.06%)  4
Paresthesia  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Peripheral motor neuropathy  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Peripheral sensory neuropathy  1  0/80 (0.00%)  0 9/79 (11.39%)  14
Presyncope  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Reversible posterior leukoencephalopathy syndrome  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Seizure  1  0/80 (0.00%)  0 2/79 (2.53%)  3
Sinus pain  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Somnolence  1  5/80 (6.25%)  5 2/79 (2.53%)  2
Stroke  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Syncope  1  2/80 (2.50%)  2 3/79 (3.80%)  3
Psychiatric disorders     
Agitation  1  3/80 (3.75%)  4 1/79 (1.27%)  1
Anxiety  1  7/80 (8.75%)  7 7/79 (8.86%)  7
Confusion  1  7/80 (8.75%)  12 9/79 (11.39%)  9
Delirium  1  6/80 (7.50%)  6 4/79 (5.06%)  4
Delusions  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Depression  1  6/80 (7.50%)  6 6/79 (7.59%)  9
Hallucinations  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Insomnia  1  10/80 (12.50%)  11 10/79 (12.66%)  11
Renal and urinary disorders     
Acute kidney injury  1  5/80 (6.25%)  5 6/79 (7.59%)  6
Chronic kidney disease  1  7/80 (8.75%)  9 7/79 (8.86%)  12
Hematuria  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Proteinuria  1  5/80 (6.25%)  7 8/79 (10.13%)  8
Renal and urinary disorders - Other  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Renal calculi  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Urinary frequency  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Urinary incontinence  1  6/80 (7.50%)  6 0/79 (0.00%)  0
Urinary retention  1  2/80 (2.50%)  2 3/79 (3.80%)  3
Urinary tract obstruction  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Urinary tract pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Urinary urgency  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Reproductive system and breast disorders     
Pelvic pain  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Penile pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Vaginal discharge  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Allergic rhinitis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Aspiration  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Atelectasis  1  7/80 (8.75%)  9 4/79 (5.06%)  5
Bronchopulmonary hemorrhage  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Bronchospasm  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Cough  1  20/80 (25.00%)  24 13/79 (16.46%)  14
Dyspnea  1  18/80 (22.50%)  20 23/79 (29.11%)  29
Epistaxis  1  4/80 (5.00%)  4 5/79 (6.33%)  5
Hiccups  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hypoxia  1  8/80 (10.00%)  9 8/79 (10.13%)  8
Nasal congestion  1  4/80 (5.00%)  4 2/79 (2.53%)  2
Pleural effusion  1  8/80 (10.00%)  9 12/79 (15.19%)  14
Pneumonitis  1  3/80 (3.75%)  3 5/79 (6.33%)  5
Pneumothorax  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Postnasal drip  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Productive cough  1  3/80 (3.75%)  5 3/79 (3.80%)  3
Pulmonary edema  1  4/80 (5.00%)  5 5/79 (6.33%)  5
Pulmonary hypertension  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Respiratory failure  1  5/80 (6.25%)  5 3/79 (3.80%)  3
Respiratory, thoracic and mediastinal disorders - Other  1  2/80 (2.50%)  2 4/79 (5.06%)  4
Sleep apnea  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Sore throat  1  5/80 (6.25%)  5 2/79 (2.53%)  2
Wheezing  1  6/80 (7.50%)  6 3/79 (3.80%)  5
Skin and subcutaneous tissue disorders     
Erythema multiforme  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Erythroderma  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hyperhidrosis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Nail loss  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pain of skin  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Periorbital edema  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Pruritus  1  2/80 (2.50%)  2 4/79 (5.06%)  4
Purpura  1  4/80 (5.00%)  4 2/79 (2.53%)  2
Rash maculo-papular  1  10/80 (12.50%)  10 10/79 (12.66%)  11
Skin and subcutaneous tissue disorders - Other  1  6/80 (7.50%)  9 11/79 (13.92%)  12
Skin hypopigmentation  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Skin induration  1  3/80 (3.75%)  4 0/79 (0.00%)  0
Skin ulceration  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Urticaria  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Vascular disorders     
Hematoma  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Hot flashes  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hypertension  1  5/80 (6.25%)  6 11/79 (13.92%)  12
Hypotension  1  16/80 (20.00%)  17 17/79 (21.52%)  19
Superficial thrombophlebitis  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Thromboembolic event  1  6/80 (7.50%)  6 3/79 (3.80%)  3
Vascular disorders - Other  1  3/80 (3.75%)  3 0/79 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Decitabine) Arm II (Decitabine and Bortezomib)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/80 (82.50%)      61/79 (77.22%)    
Blood and lymphatic system disorders     
Anemia  1  63/80 (78.75%)  253 59/79 (74.68%)  239
Blood and lymphatic system disorders - Other  1  3/80 (3.75%)  13 2/79 (2.53%)  2
Disseminated intravascular coagulation  1  6/80 (7.50%)  7 3/79 (3.80%)  3
Febrile neutropenia  1  34/80 (42.50%)  53 33/79 (41.77%)  45
Leukocytosis  1  4/80 (5.00%)  8 3/79 (3.80%)  6
Thrombotic thrombocytopenic purpura  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Cardiac disorders     
Acute coronary syndrome  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Atrial fibrillation  1  3/80 (3.75%)  3 6/79 (7.59%)  7
Atrial flutter  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Atrioventricular block first degree  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Cardiac arrest  1  0/80 (0.00%)  0 2/79 (2.53%)  3
Cardiac disorders - Other  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Chest pain - cardiac  1  2/80 (2.50%)  3 3/79 (3.80%)  8
Conduction disorder  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Heart failure  1  2/80 (2.50%)  2 4/79 (5.06%)  6
Left ventricular systolic dysfunction  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Myocardial infarction  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Palpitations  1  1/80 (1.25%)  2 2/79 (2.53%)  3
Pericardial effusion  1  1/80 (1.25%)  2 5/79 (6.33%)  7
Right ventricular dysfunction  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Sinus bradycardia  1  2/80 (2.50%)  2 5/79 (6.33%)  5
Sinus tachycardia  1  9/80 (11.25%)  11 6/79 (7.59%)  14
Supraventricular tachycardia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Ventricular arrhythmia  1  3/80 (3.75%)  3 6/79 (7.59%)  6
Ventricular tachycardia  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Ear pain  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Tinnitus  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Vertigo  1  2/80 (2.50%)  2 1/79 (1.27%)  4
Endocrine disorders     
Adrenal insufficiency  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Endocrine disorders - Other  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hyperparathyroidism  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hyperthyroidism  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hypothyroidism  1  1/80 (1.25%)  2 3/79 (3.80%)  6
Eye disorders     
Blurred vision  1  4/80 (5.00%)  24 6/79 (7.59%)  12
Conjunctivitis  1  2/80 (2.50%)  3 0/79 (0.00%)  0
Dry eye  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Eye disorders - Other  1  2/80 (2.50%)  5 4/79 (5.06%)  4
Eye pain  1  1/80 (1.25%)  1 1/79 (1.27%)  9
Retinal vascular disorder  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Vitreous hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Watering eyes  1  1/80 (1.25%)  4 0/79 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  2/80 (2.50%)  2 2/79 (2.53%)  3
Abdominal pain  1  8/80 (10.00%)  10 15/79 (18.99%)  23
Anal pain  1  5/80 (6.25%)  6 0/79 (0.00%)  0
Ascites  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Bloating  1  3/80 (3.75%)  3 4/79 (5.06%)  8
Colitis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Colonic hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Constipation  1  38/80 (47.50%)  78 34/79 (43.04%)  65
Dental caries  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Diarrhea  1  34/80 (42.50%)  60 33/79 (41.77%)  48
Dry mouth  1  5/80 (6.25%)  6 7/79 (8.86%)  9
Dyspepsia  1  7/80 (8.75%)  8 4/79 (5.06%)  8
Dysphagia  1  7/80 (8.75%)  8 1/79 (1.27%)  1
Enterocolitis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Esophagitis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Fecal incontinence  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Flatulence  1  1/80 (1.25%)  2 1/79 (1.27%)  1
Gastric hemorrhage  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Gastroesophageal reflux disease  1  7/80 (8.75%)  18 5/79 (6.33%)  6
Gastrointestinal disorders - Other  1  4/80 (5.00%)  5 7/79 (8.86%)  10
Gingival pain  1  1/80 (1.25%)  1 2/79 (2.53%)  5
Hemorrhoidal hemorrhage  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Hemorrhoids  1  6/80 (7.50%)  7 7/79 (8.86%)  7
Ileus  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Lower gastrointestinal hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Mucositis oral  1  14/80 (17.50%)  19 13/79 (16.46%)  16
Nausea  1  34/80 (42.50%)  67 34/79 (43.04%)  95
Oral hemorrhage  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Oral pain  1  8/80 (10.00%)  11 4/79 (5.06%)  4
Periodontal disease  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Peritoneal necrosis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Rectal hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Rectal pain  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Stomach pain  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Typhlitis  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Vomiting  1  13/80 (16.25%)  17 20/79 (25.32%)  36
General disorders     
Chills  1  9/80 (11.25%)  19 16/79 (20.25%)  21
Edema face  1  0/80 (0.00%)  0 4/79 (5.06%)  4
Edema limbs  1  32/80 (40.00%)  58 25/79 (31.65%)  51
Edema trunk  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Facial pain  1  0/80 (0.00%)  0 2/79 (2.53%)  4
Fatigue  1  53/80 (66.25%)  173 51/79 (64.56%)  170
Fever  1  15/80 (18.75%)  16 8/79 (10.13%)  10
Flu like symptoms  1  0/80 (0.00%)  0 2/79 (2.53%)  5
Gait disturbance  1  0/80 (0.00%)  0 1/79 (1.27%)  1
General disorders and administration site conditions - Other  1  8/80 (10.00%)  9 8/79 (10.13%)  10
Infusion related reaction  1  2/80 (2.50%)  3 0/79 (0.00%)  0
Infusion site extravasation  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Injection site reaction  1  0/80 (0.00%)  0 1/79 (1.27%)  3
Localized edema  1  3/80 (3.75%)  3 2/79 (2.53%)  2
Malaise  1  5/80 (6.25%)  6 3/79 (3.80%)  4
Non-cardiac chest pain  1  2/80 (2.50%)  3 7/79 (8.86%)  8
Pain  1  10/80 (12.50%)  23 10/79 (12.66%)  14
Hepatobiliary disorders     
Cholecystitis  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hepatic failure  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hepatobiliary disorders - Other  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Portal vein thrombosis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Immune system disorders     
Allergic reaction  1  1/80 (1.25%)  1 1/79 (1.27%)  2
Anaphylaxis  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Infections and infestations     
Bronchial infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Catheter related infection  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Conjunctivitis infective  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Enterocolitis infectious  1  2/80 (2.50%)  2 3/79 (3.80%)  3
Gallbladder infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Gum infection  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Hepatitis viral  1  1/80 (1.25%)  5 0/79 (0.00%)  0
Infections and infestations - Other  1  7/80 (8.75%)  7 11/79 (13.92%)  14
Joint infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Lip infection  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Lung infection  1  14/80 (17.50%)  23 12/79 (15.19%)  14
Mucosal infection  1  3/80 (3.75%)  3 1/79 (1.27%)  1
Nail infection  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Otitis externa  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Paronychia  1  1/80 (1.25%)  1 1/79 (1.27%)  2
Pharyngitis  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Phlebitis infective  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Salivary gland infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Sepsis  1  3/80 (3.75%)  3 3/79 (3.80%)  4
Sinusitis  1  5/80 (6.25%)  5 3/79 (3.80%)  6
Skin infection  1  9/80 (11.25%)  11 10/79 (12.66%)  17
Small intestine infection  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Tooth infection  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Upper respiratory infection  1  6/80 (7.50%)  6 1/79 (1.27%)  2
Urinary tract infection  1  7/80 (8.75%)  7 8/79 (10.13%)  10
Wound infection  1  3/80 (3.75%)  5 1/79 (1.27%)  1
Injury, poisoning and procedural complications     
Bruising  1  12/80 (15.00%)  23 4/79 (5.06%)  5
Fall  1  3/80 (3.75%)  5 10/79 (12.66%)  12
Fracture  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Injury, poisoning and procedural complications - Other  1  5/80 (6.25%)  6 3/79 (3.80%)  3
Vascular access complication  1  0/80 (0.00%)  0 1/79 (1.27%)  2
Investigations     
Activated partial thromboplastin time prolonged  1  5/80 (6.25%)  7 9/79 (11.39%)  17
Alanine aminotransferase increased  1  22/80 (27.50%)  38 19/79 (24.05%)  44
Alkaline phosphatase increased  1  17/80 (21.25%)  34 15/79 (18.99%)  29
Aspartate aminotransferase increased  1  28/80 (35.00%)  40 27/79 (34.18%)  54
Blood bilirubin increased  1  20/80 (25.00%)  44 12/79 (15.19%)  16
Blood prolactin abnormal  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Cardiac troponin I increased  1  1/80 (1.25%)  1 2/79 (2.53%)  2
Cholesterol high  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Creatinine increased  1  15/80 (18.75%)  26 20/79 (25.32%)  62
Ejection fraction decreased  1  0/80 (0.00%)  0 1/79 (1.27%)  3
Electrocardiogram QT corrected interval prolonged  1  3/80 (3.75%)  3 5/79 (6.33%)  8
GGT increased  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Haptoglobin decreased  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hemoglobin increased  1  2/80 (2.50%)  7 2/79 (2.53%)  2
INR increased  1  10/80 (12.50%)  25 13/79 (16.46%)  23
Investigations - Other  1  5/80 (6.25%)  20 5/79 (6.33%)  26
Lymphocyte count decreased  1  19/80 (23.75%)  45 18/79 (22.78%)  54
Lymphocyte count increased  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Neutrophil count decreased  1  62/80 (77.50%)  266 56/79 (70.89%)  224
Platelet count decreased  1  62/80 (77.50%)  233 59/79 (74.68%)  236
Weight gain  1  4/80 (5.00%)  7 3/79 (3.80%)  4
Weight loss  1  14/80 (17.50%)  31 12/79 (15.19%)  36
White blood cell decreased  1  30/80 (37.50%)  125 29/79 (36.71%)  98
Metabolism and nutrition disorders     
Acidosis  1  3/80 (3.75%)  3 0/79 (0.00%)  0
Alkalosis  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Anorexia  1  32/80 (40.00%)  56 30/79 (37.97%)  78
Dehydration  1  3/80 (3.75%)  6 4/79 (5.06%)  11
Hypercalcemia  1  4/80 (5.00%)  4 2/79 (2.53%)  2
Hyperglycemia  1  40/80 (50.00%)  114 38/79 (48.10%)  122
Hyperkalemia  1  4/80 (5.00%)  4 7/79 (8.86%)  10
Hypermagnesemia  1  0/80 (0.00%)  0 3/79 (3.80%)  5
Hypernatremia  1  4/80 (5.00%)  7 1/79 (1.27%)  2
Hypertriglyceridemia  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hyperuricemia  1  3/80 (3.75%)  6 2/79 (2.53%)  2
Hypoalbuminemia  1  33/80 (41.25%)  89 37/79 (46.84%)  94
Hypocalcemia  1  27/80 (33.75%)  56 25/79 (31.65%)  66
Hypoglycemia  1  3/80 (3.75%)  4 5/79 (6.33%)  15
Hypokalemia  1  25/80 (31.25%)  40 26/79 (32.91%)  46
Hypomagnesemia  1  14/80 (17.50%)  33 13/79 (16.46%)  19
Hyponatremia  1  24/80 (30.00%)  63 26/79 (32.91%)  48
Hypophosphatemia  1  14/80 (17.50%)  16 11/79 (13.92%)  14
Metabolism and nutrition disorders - Other  1  3/80 (3.75%)  7 4/79 (5.06%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia  1  13/80 (16.25%)  26 4/79 (5.06%)  25
Arthritis  1  4/80 (5.00%)  8 4/79 (5.06%)  11
Back pain  1  12/80 (15.00%)  18 16/79 (20.25%)  26
Bone pain  1  3/80 (3.75%)  5 8/79 (10.13%)  8
Chest wall pain  1  0/80 (0.00%)  0 3/79 (3.80%)  3
Flank pain  1  4/80 (5.00%)  5 2/79 (2.53%)  2
Generalized muscle weakness  1  22/80 (27.50%)  39 14/79 (17.72%)  40
Joint effusion  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Muscle weakness left-sided  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Muscle weakness lower limb  1  3/80 (3.75%)  3 2/79 (2.53%)  2
Muscle weakness upper limb  1  1/80 (1.25%)  1 1/79 (1.27%)  5
Musculoskeletal and connective tissue disorder - Other  1  8/80 (10.00%)  18 5/79 (6.33%)  7
Musculoskeletal deformity  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Myalgia  1  7/80 (8.75%)  9 7/79 (8.86%)  24
Myositis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Neck pain  1  2/80 (2.50%)  2 2/79 (2.53%)  3
Pain in extremity  1  10/80 (12.50%)  18 9/79 (11.39%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  3/80 (3.75%)  3 1/79 (1.27%)  1
Treatment related secondary malignancy  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Nervous system disorders     
Acoustic nerve disorder NOS  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Arachnoiditis  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Cognitive disturbance  1  1/80 (1.25%)  5 2/79 (2.53%)  3
Dizziness  1  13/80 (16.25%)  22 22/79 (27.85%)  37
Dysgeusia  1  3/80 (3.75%)  7 6/79 (7.59%)  13
Headache  1  15/80 (18.75%)  22 22/79 (27.85%)  30
Intracranial hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Lethargy  1  2/80 (2.50%)  3 2/79 (2.53%)  2
Nervous system disorders - Other  1  5/80 (6.25%)  8 4/79 (5.06%)  9
Neuralgia  1  0/80 (0.00%)  0 2/79 (2.53%)  8
Peripheral motor neuropathy  1  0/80 (0.00%)  0 3/79 (3.80%)  9
Peripheral sensory neuropathy  1  2/80 (2.50%)  3 19/79 (24.05%)  60
Presyncope  1  0/80 (0.00%)  0 6/79 (7.59%)  10
Seizure  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Sinus pain  1  3/80 (3.75%)  3 1/79 (1.27%)  1
Somnolence  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Stroke  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Syncope  1  1/80 (1.25%)  1 4/79 (5.06%)  7
Tremor  1  1/80 (1.25%)  1 2/79 (2.53%)  3
Psychiatric disorders     
Agitation  1  1/80 (1.25%)  1 1/79 (1.27%)  2
Anxiety  1  9/80 (11.25%)  24 9/79 (11.39%)  15
Confusion  1  8/80 (10.00%)  10 7/79 (8.86%)  8
Delirium  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Depression  1  13/80 (16.25%)  23 9/79 (11.39%)  24
Hallucinations  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Insomnia  1  15/80 (18.75%)  32 12/79 (15.19%)  23
Psychiatric disorders - Other  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  4/80 (5.00%)  4 2/79 (2.53%)  3
Chronic kidney disease  1  6/80 (7.50%)  14 5/79 (6.33%)  28
Cystitis noninfective  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Hematuria  1  5/80 (6.25%)  6 6/79 (7.59%)  9
Hemoglobinuria  1  1/80 (1.25%)  2 0/79 (0.00%)  0
Proteinuria  1  3/80 (3.75%)  4 6/79 (7.59%)  8
Renal and urinary disorders - Other  1  4/80 (5.00%)  6 2/79 (2.53%)  3
Renal calculi  1  1/80 (1.25%)  4 1/79 (1.27%)  1
Urinary frequency  1  5/80 (6.25%)  5 3/79 (3.80%)  3
Urinary incontinence  1  4/80 (5.00%)  5 3/79 (3.80%)  3
Urinary retention  1  3/80 (3.75%)  4 4/79 (5.06%)  5
Urinary tract obstruction  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Urinary tract pain  1  0/80 (0.00%)  0 3/79 (3.80%)  3
Urinary urgency  1  2/80 (2.50%)  2 0/79 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  1/80 (1.25%)  2 0/79 (0.00%)  0
Genital edema  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Pelvic pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Penile pain  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Perineal pain  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Reproductive system and breast disorders - Other  1  0/80 (0.00%)  0 3/79 (3.80%)  4
Scrotal pain  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Vaginal pain  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  5/80 (6.25%)  7 1/79 (1.27%)  1
Aspiration  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Atelectasis  1  3/80 (3.75%)  3 2/79 (2.53%)  2
Bronchopulmonary hemorrhage  1  5/80 (6.25%)  6 0/79 (0.00%)  0
Cough  1  28/80 (35.00%)  45 16/79 (20.25%)  36
Dyspnea  1  40/80 (50.00%)  75 33/79 (41.77%)  63
Epistaxis  1  7/80 (8.75%)  8 8/79 (10.13%)  10
Hiccups  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hoarseness  1  4/80 (5.00%)  4 2/79 (2.53%)  2
Hypoxia  1  5/80 (6.25%)  5 4/79 (5.06%)  4
Laryngeal inflammation  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Laryngeal mucositis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Mediastinal hemorrhage  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Nasal congestion  1  7/80 (8.75%)  8 5/79 (6.33%)  10
Pharyngolaryngeal pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pleural effusion  1  6/80 (7.50%)  8 6/79 (7.59%)  8
Pleuritic pain  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pneumonitis  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Pneumothorax  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Postnasal drip  1  6/80 (7.50%)  6 2/79 (2.53%)  2
Productive cough  1  2/80 (2.50%)  2 2/79 (2.53%)  2
Pulmonary edema  1  3/80 (3.75%)  3 6/79 (7.59%)  8
Pulmonary hypertension  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Respiratory failure  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders - Other  1  10/80 (12.50%)  21 8/79 (10.13%)  10
Sinus disorder  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Sleep apnea  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Sore throat  1  8/80 (10.00%)  10 8/79 (10.13%)  11
Tracheal mucositis  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Wheezing  1  5/80 (6.25%)  5 2/79 (2.53%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  2/80 (2.50%)  6 3/79 (3.80%)  5
Bullous dermatitis  1  0/80 (0.00%)  0 2/79 (2.53%)  3
Dry skin  1  4/80 (5.00%)  4 3/79 (3.80%)  3
Erythema multiforme  1  5/80 (6.25%)  6 2/79 (2.53%)  2
Erythroderma  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Hyperhidrosis  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Nail loss  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Pain of skin  1  2/80 (2.50%)  3 0/79 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Periorbital edema  1  0/80 (0.00%)  0 2/79 (2.53%)  2
Pruritus  1  4/80 (5.00%)  4 5/79 (6.33%)  9
Purpura  1  6/80 (7.50%)  7 6/79 (7.59%)  9
Rash maculo-papular  1  25/80 (31.25%)  35 21/79 (26.58%)  32
Scalp pain  1  0/80 (0.00%)  0 1/79 (1.27%)  1
Skin and subcutaneous tissue disorders - Other  1  16/80 (20.00%)  29 16/79 (20.25%)  25
Skin induration  1  1/80 (1.25%)  3 1/79 (1.27%)  1
Skin ulceration  1  1/80 (1.25%)  1 1/79 (1.27%)  1
Urticaria  1  1/80 (1.25%)  1 1/79 (1.27%)  5
Surgical and medical procedures     
Surgical and medical procedures - Other  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Vascular disorders     
Flushing  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Hematoma  1  4/80 (5.00%)  5 2/79 (2.53%)  2
Hypertension  1  11/80 (13.75%)  21 12/79 (15.19%)  17
Hypotension  1  16/80 (20.00%)  20 26/79 (32.91%)  41
Phlebitis  1  3/80 (3.75%)  3 0/79 (0.00%)  0
Superficial thrombophlebitis  1  2/80 (2.50%)  2 1/79 (1.27%)  1
Thromboembolic event  1  5/80 (6.25%)  5 3/79 (3.80%)  4
Vascular disorders - Other  1  1/80 (1.25%)  1 0/79 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gail Roboz, M.D
Organization: Weill Medical College of Cornell University
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01420926     History of Changes
Other Study ID Numbers: NCI-2011-02987
NCI-2011-02987 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000709218
CALGB-11002 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-11002 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2011
First Posted: August 22, 2011
Results First Submitted: August 30, 2016
Results First Posted: October 24, 2016
Last Update Posted: December 10, 2018