Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 372 for:    LENALIDOMIDE AND Dexamethasone

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01049945
Recruitment Status : Unknown
Verified April 2016 by Mayo Clinic.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2010
Results First Posted : March 30, 2015
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Refractory Multiple Myeloma
Interventions Drug: bendamustine hydrochloride
Drug: lenalidomide
Drug: dexamethasone
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5 Phase II, Dose Level 4
Hide Arm/Group Description Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Period Title: Overall Study
Started 3 6 3 6 3 49
Completed 3 6 3 6 3 49
Not Completed 0 0 0 0 0 0
Arm/Group Title Phase I Maximum Tolerated Dose, Dose Level 4 Total
Hide Arm/Group Description Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together. Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together. Total of all reporting groups
Overall Number of Baseline Participants 15 55 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 55 participants 70 participants
63.5
(41.8 to 75.0)
61.9
(40.1 to 86.3)
62.3
(40.1 to 86.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 55 participants 70 participants
Female
3
  20.0%
27
  49.1%
30
  42.9%
Male
12
  80.0%
28
  50.9%
40
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 55 participants 70 participants
15 55 70
1.Primary Outcome
Title Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)
Hide Description

The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:

  • Grade 2 neuropathy with pain
  • Any grade 3 Non-Hematologic toxicity
  • Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.
  • Grade 4 neutropenia
  • Febrile neutropenia
  • Grade 4 thrombocytopenia
  • Grade 3 thrombocytopenia associated with bleeding
  • Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.

We are reporting the results of this endpoint as the number of DLTs per dose level.

Time Frame One cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants registered to the Phase I portion of this study were evaluable for this endpoint.
Arm/Group Title Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5
Hide Arm/Group Description:
Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 3 6 3 6 3
Measure Type: Number
Unit of Measure: Dose Limiting Toxic Events
0 1 0 0 2
2.Primary Outcome
Title Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).
Hide Description

Complete response (CR)

- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.

Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow

Near complete response (nCR) A CR, with the persistence of original monoclonal protein

Very good partial response (VGPR)

- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h

Partial response (PR)

  • ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.
  • a ≥50% decrease in the difference between involved and uninvolved FLC levels
  • or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.
Time Frame Up to 6 cycles of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.
Arm/Group Title Maximum Tolerated Dose, Dose Level 4
Hide Arm/Group Description:
Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(30 to 58)
3.Secondary Outcome
Title Duration of Response (Phase II)
Hide Description [Not Specified]
Time Frame Up to 2 years from study completion (6 years total)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Progression (Phase II)
Hide Description [Not Specified]
Time Frame Up to 2 years from study completion (6 years total)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Progression Free Survival (Phase II)
Hide Description [Not Specified]
Time Frame Up to 2 years from study completion (6 years total)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival (Phase II)
Hide Description [Not Specified]
Time Frame Up to 2 years from study completion (6 years total)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5 Phase II, Dose Level 4
Hide Arm/Group Description Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
All-Cause Mortality
Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5 Phase II, Dose Level 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5 Phase II, Dose Level 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      2/6 (33.33%)      2/3 (66.67%)      2/6 (33.33%)      1/3 (33.33%)      24/49 (48.98%)    
Blood and lymphatic system disorders             
Anemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Febrile neutropenia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders             
Abdominal pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Constipation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Diarrhea  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Ileus  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pancreatitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
General disorders             
Chest pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Disease progression  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 3/49 (6.12%)  3
Fatigue  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Fever  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Hepatobiliary disorders             
Cholecystitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Infections and infestations             
Herpes Zoster  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Appendicitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Bronchitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Opportunistic infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Pneumonia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 6/49 (12.24%)  6
Upper respiratory infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/49 (0.00%)  0
Investigations             
Creatinine increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
Neutrophil count decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 2/49 (4.08%)  2
Platelet count decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Metabolism and nutrition disorders             
Dehydration  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Hypokalemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Serum calcium decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders             
Back pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Myalgia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders             
Ataxia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
CNS hemorrhage/bleeding  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Ischemia cerebrovascular  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Peripheral motor neuropathy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Seizure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
Syncope  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Renal and urinary disorders             
Renal failure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders             
Dyspnea  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pleural effusion  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Vascular disorders             
Hypotension  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Thrombosis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I, Dose Level 1 Phase I, Dose Level 2 Phase I, Dose Level 3 Phase I, Dose Level 4 Phase I, Dose Level 5 Phase II, Dose Level 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      6/6 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      3/3 (100.00%)      49/49 (100.00%)    
Blood and lymphatic system disorders             
Anemia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 1/3 (33.33%)  1 22/49 (44.90%)  25
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/49 (2.04%)  2
Cardiac pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Conduction disorder  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Edema  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0 5/49 (10.20%)  5
Palpitations  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Sinus bradycardia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 4/49 (8.16%)  4
Sinus tachycardia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Ventricular arrhythmia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Endocrine disorders             
Hypothyroidism  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Eye disorders             
Cataract  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Eye disorder  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Vision  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Watering eyes  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorders             
Abdominal pain  1  1/3 (33.33%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 1/3 (33.33%)  1 4/49 (8.16%)  5
Colitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
Constipation  1  1/3 (33.33%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 15/49 (30.61%)  15
Diarrhea  1  3/3 (100.00%)  3 2/6 (33.33%)  3 1/3 (33.33%)  1 5/6 (83.33%)  7 1/3 (33.33%)  1 24/49 (48.98%)  26
Dry mouth  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Dyspepsia  1  1/3 (33.33%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 9/49 (18.37%)  10
Dysphagia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 4/49 (8.16%)  4
Flatulence  1  1/3 (33.33%)  1 1/6 (16.67%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  3
Melena/GI bleeding  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
Mucositis oral  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0 2/49 (4.08%)  2
Nausea  1  2/3 (66.67%)  2 2/6 (33.33%)  2 0/3 (0.00%)  0 3/6 (50.00%)  3 1/3 (33.33%)  1 23/49 (46.94%)  23
Oral pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Pancreatitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/49 (0.00%)  0
Rectal hemorrhage  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Vomiting  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 14/49 (28.57%)  14
General disorders             
Chest pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 4/49 (8.16%)  4
Chills  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 3/49 (6.12%)  3
Edema limbs  1  1/3 (33.33%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 7/49 (14.29%)  9
Fatigue  1  3/3 (100.00%)  4 3/6 (50.00%)  4 0/3 (0.00%)  0 4/6 (66.67%)  4 2/3 (66.67%)  2 27/49 (55.10%)  30
Fever  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 11/49 (22.45%)  11
Gait abnormal  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Gait disturbance  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Injection site reaction  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hepatobiliary disorders             
Cholecystitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Immune system disorders             
Hypersensitivity  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 4/49 (8.16%)  4
Infections and infestations             
Herpes Zoster  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 7/49 (14.29%)  8
Bronchitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Colitis, infectious (e.g., Clostridium difficile)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Gingival infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Mucosal infection  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Nail infection  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Opportunistic infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Otitis externa  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Pneumonia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/49 (4.08%)  2
Sinusitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Skin infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0 1/49 (2.04%)  1
Upper aerodigestive tract infection  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Upper respiratory infection  1  1/3 (33.33%)  1 3/6 (50.00%)  4 0/3 (0.00%)  0 4/6 (66.67%)  5 2/3 (66.67%)  2 10/49 (20.41%)  11
Urinary tract infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Injury, poisoning and procedural complications             
Bruising  1  1/3 (33.33%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0 11/49 (22.45%)  12
Fracture  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Investigations             
Alkaline phosphatase increased  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Creatinine increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Leukocyte count decreased  1  2/3 (66.67%)  3 3/6 (50.00%)  3 3/3 (100.00%)  3 5/6 (83.33%)  5 3/3 (100.00%)  4 39/49 (79.59%)  39
Lymphocyte count decreased  1  2/3 (66.67%)  3 5/6 (83.33%)  6 3/3 (100.00%)  3 6/6 (100.00%)  6 2/3 (66.67%)  2 42/49 (85.71%)  43
Neutrophil count decreased  1  0/3 (0.00%)  0 1/6 (16.67%)  2 3/3 (100.00%)  4 5/6 (83.33%)  7 3/3 (100.00%)  4 40/49 (81.63%)  48
Platelet count decreased  1  1/3 (33.33%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 4/6 (66.67%)  6 1/3 (33.33%)  1 32/49 (65.31%)  34
Weight gain  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Weight loss  1  0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 2/6 (33.33%)  2 1/3 (33.33%)  1 14/49 (28.57%)  14
White blood cell decreased  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Metabolism and nutrition disorders             
Acidosis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Anorexia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 7/49 (14.29%)  7
Blood bicarbonate decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Blood uric acid increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Dehydration  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Hyperglycemia  1  1/3 (33.33%)  2 2/6 (33.33%)  2 1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 6/49 (12.24%)  6
Hypokalemia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 7/49 (14.29%)  7
Serum calcium decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Serum calcium increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Serum magnesium decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/49 (2.04%)  1
Serum phosphate decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 3/49 (6.12%)  3
Serum potassium decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Serum sodium decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/49 (2.04%)  1
Tumor lysis syndrome  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Leg Cramp  1  2/3 (66.67%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 8/49 (16.33%)  14
Arthralgia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Back pain  1  3/3 (100.00%)  3 1/6 (16.67%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 10/49 (20.41%)  11
Musculoskeletal  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Myalgia  1  2/3 (66.67%)  2 1/6 (16.67%)  1 1/3 (33.33%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0 19/49 (38.78%)  23
Neck pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pain in extremity  1  2/3 (66.67%)  2 2/6 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 5/49 (10.20%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  3
Nervous system disorders             
Ataxia  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Dizziness  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 8/49 (16.33%)  8
Dysgeusia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 3/49 (6.12%)  3
Encephalopathy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Facial nerve disorder  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Headache  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 8/49 (16.33%)  8
Ischemia cerebrovascular  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Peripheral motor neuropathy  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Peripheral sensory neuropathy  1  1/3 (33.33%)  1 3/6 (50.00%)  3 0/3 (0.00%)  0 2/6 (33.33%)  4 1/3 (33.33%)  1 14/49 (28.57%)  14
Somnolence  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Tremor  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 3/49 (6.12%)  3
Psychiatric disorders             
Agitation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Anxiety  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/49 (4.08%)  2
Confusion  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Depression  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Hallucinations  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Insomnia  1  2/3 (66.67%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 11/49 (22.45%)  11
Psychiatric disorders - Other, specify  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Renal and urinary disorders             
Cystitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Glomerular filtration rate decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hematuria (absence of vaginal bleeding)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Renal failure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Urinary frequency  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Reproductive system and breast disorders             
Pelvic pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Allergic rhinitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Apnea  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Cough  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 8/49 (16.33%)  8
Dyspnea  1  2/3 (66.67%)  2 0/6 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 2/3 (66.67%)  2 6/49 (12.24%)  6
Epistaxis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hemoptysis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hiccups  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pharyngolaryngeal pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Pleural effusion  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pneumonitis  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders             
Alopecia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Decubitus ulcer  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Dry skin  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Erythema multiforme  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Hyperhidrosis  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Nail disorder  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Pain of skin  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Pruritus  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 3/49 (6.12%)  4
Rash acneiform  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Rash desquamating  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Rash maculo-papular  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  3 1/3 (33.33%)  1 10/49 (20.41%)  11
Skin atrophy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Sweating  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/49 (2.04%)  1
Vascular disorders             
Flushing  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hematoma  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/49 (0.00%)  0
Hypertension  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Hypotension  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/49 (4.08%)  2
Phlebitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/49 (2.04%)  1
Thrombosis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 4/49 (8.16%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shaji K. Kumar, M.D.
Organization: Mayo Clinic
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01049945     History of Changes
Other Study ID Numbers: MMRC-020-021
NCI-2009-01535 ( Registry Identifier: NCI's CTRO )
MMRC-020-021 ( Other Identifier: Mayo Clinic Cancer Center & MMRC )
09-004211 ( Other Identifier: Mayo Clinic IRB )
C18083/6125 ( Other Identifier: Cephalon protocol )
First Submitted: January 14, 2010
First Posted: January 15, 2010
Results First Submitted: March 23, 2015
Results First Posted: March 30, 2015
Last Update Posted: May 27, 2016