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Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00398086
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : August 21, 2013
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: Albumin-bound paclitaxel
Enrollment 67
Recruitment Details Enrollment was initiated in November 2006 and completed in September 2008. Sixty-seven patients were enrolled at four sites in the US.
Pre-assignment Details In Phase 1, patients were assigned sequentially to one of the three potential dose levels based on the dose cohort currently enrolling patients (a total of 30 patients). After the maximum tolerated dose (MTD) was determined, all subsequent patients were enrolled at that dose level in Phase 2 (37 patients).
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Period Title: Overall Study
Started 20 44 3
Phase 1, Dose Escalation Population 20 7 3
Completed 11 [1] 21 [1] 1 [1]
Not Completed 9 23 2
Reason Not Completed
Unacceptable Toxicity             2             8             2
Adverse Event             1             4             0
Physician Decision             1             4             0
Withdrawal by Subject             5             7             0
[1]
Completed defined as discontinuation due to progressive disease.
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2 Total
Hide Arm/Group Description Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 20 44 3 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 44 participants 3 participants 67 participants
62.0
(30 to 86)
61.5
(28 to 78)
69.0
(53 to 72)
62.0
(28 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
Female
9
  45.0%
25
  56.8%
1
  33.3%
35
  52.2%
Male
11
  55.0%
19
  43.2%
2
  66.7%
32
  47.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
Asian 1 1 0 2
Black, of African Heritage 0 2 0 2
White, Non-Hispanic, and Non-Latino 16 37 1 54
White, Hispanic, or Latino 2 4 2 8
Other 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 44 participants 3 participants 67 participants
20 44 3 67
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
0 (Fully Active) 9 22 2 33
1 (Restrictive but Ambulatory) 11 22 1 34
[1]
Measure Description: A scale used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Histology of Primary Diagnosis: Adenocarcinoma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
20 44 3 67
Time from First Documented Metastasis/Relapse to Study Entry  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants 44 participants 3 participants 67 participants
0.8
(0 to 11)
0.7
(0 to 13)
0.3
(0 to 1)
0.7
(0 to 13)
Current Site(s) of Metastasis/Relapse   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
Skin/Soft Tissue 0 1 0 1
Supraclavicular Nodes 0 2 0 2
Axilla 2 0 0 2
Bone 1 3 0 4
Lung/Thoracic 5 18 1 24
Liver 11 33 2 46
Abdomen/Peritoneum 16 37 1 54
Pelvis 1 3 1 5
Other 8 6 0 14
[1]
Measure Description: Patients could be in multiple sites of metastasis/relapse categories.
Dominant Current Site of Metastasis/Relapse  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 44 participants 3 participants 67 participants
Visceral 19 44 3 66
Non-visceral 1 0 0 1
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities
Hide Description

A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:

  • Grade 4 neutropenia lasting >3 days in the absence of growth factor support;
  • Grade 4 neutropenia associated with fever >38.5°C;
  • Any other Grade 4 hematological toxicity;
  • Grade 3 thrombocytopenia with hemorrhage;
  • Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;
  • Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue.
Time Frame Cycle 1 (Days 1-28)
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 treated population
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 7 3
Measure Type: Number
Unit of Measure: participants
4 0 1
2.Secondary Outcome
Title Number of Participants With Adverse Events (AE)
Hide Description

An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient’s treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.

A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.

Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE.

Time Frame Up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients: all enrolled patients who received at least one dose of study drug.
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 44 3
Measure Type: Number
Unit of Measure: participants
Patients with at least 1 AE 20 44 3
At least 1 grade 3 or higher AE 15 42 3
At least 1 treatment-related AE 18 42 3
At least 1 treatment-related grade 3 to 5 AE 11 38 3
Patients with at least 1 SAE 10 24 1
Patients with at least 1 treatment-related SAE 4 12 1
At least 1 AE and drug permanently discontinued 3 12 2
At least 1 TRAE and drug permanently discontinued 2 8 2
At least 1 dose reduction due to TRAE 4 10 1
At least 1 dose interruption due to AE 1 0 0
At least 1 treatment-related AE dose interruption 1 0 0
At least 1 treatment-emergent dose delay due to AE 14 27 3
At least 1 treatment-related dose delay due to AE 13 27 3
At least 1 AE resulting in death 0 1 1
3.Secondary Outcome
Title Percentage of Participants Who Achieved an Objective Confirmed Overall Response
Hide Description

Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.

CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.

PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing.

Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 44 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25
(8.7 to 49.1)
39
(24.2 to 53.0)
0 [1] 
(NA to NA)
[1]
Could not be calculated as no participants responded in this group
4.Secondary Outcome
Title Percentage of Participants With Disease Control
Hide Description

Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.

Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 44 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55
(33.2 to 76.8)
55
(39.8 to 69.3)
33
(0.8 to 90.6)
5.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.

Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 44 3
Median (95% Confidence Interval)
Unit of Measure: months
6.1 [1] 
(3.7 to NA)
6.9
(4.8 to 9.2)
1.6
(0.5 to 10.0)
[1]
Could not be estimated due to low number of events.
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients with an overall confirmed Complete Response or Partial Response.
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 5 17 0
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(2.4 to NA)
7.3
(5.5 to 21.9)
[1]
Not estimable due to the low number of events.
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 44 3
Median (95% Confidence Interval)
Unit of Measure: months
9.3
(6.6 to 11.9)
12.2
(8.9 to 17.9)
6.1
(0.5 to 17.9)
8.Secondary Outcome
Title Maximal Degree of Myelosuppression
Hide Description The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.
Time Frame During the treatment phase, up to a maximum of 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients with available data
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 43 3
Mean (Standard Deviation)
Unit of Measure: x10^9/L
Absolute neutrophil count 1.38  (1.541) 0.96  (1.446) 0.47  (0.460)
White blood cell count 2.69  (1.734) 2.18  (1.849) 1.52  (1.484)
Platelet count 120.3  (79.02) 88.3  (62.10) 58.7  (48.64)
9.Secondary Outcome
Title Maximal Degree of Anemia
Hide Description The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.
Time Frame During the treatment phase, up to a maximum of 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients with available data
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description:
Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
Overall Number of Participants Analyzed 20 43 3
Mean (Standard Deviation)
Unit of Measure: g/L
95.1  (12.85) 91.8  (10.43) 95.3  (15.37)
Time Frame Adverse events were collected up to 30 days after the last dose (a maximum of 25 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 100 mg/m^2 125 mg/m^2 150 mg/m^2
Hide Arm/Group Description Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity. Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
All-Cause Mortality
100 mg/m^2 125 mg/m^2 150 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
100 mg/m^2 125 mg/m^2 150 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   24/44 (54.55%)   1/3 (33.33%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Pancytopenia  1  0/20 (0.00%)  2/44 (4.55%)  0/3 (0.00%) 
Anaemia  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Neutropenia  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Thrombocytopenia  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Supraventricular tachycardia  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Gastrointestinal haemorrhage  1  0/20 (0.00%)  2/44 (4.55%)  0/3 (0.00%) 
Intestinal obstruction  1  0/20 (0.00%)  2/44 (4.55%)  0/3 (0.00%) 
Small intestinal obstruction  1  0/20 (0.00%)  2/44 (4.55%)  0/3 (0.00%) 
Ascites  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Duodenal obstruction  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Enterocutaneous fistula  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Ileus  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Ileus paralytic  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Nausea  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Obstruction gastric  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
General disorders       
Pyrexia  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Pain  1  2/20 (10.00%)  0/44 (0.00%)  0/3 (0.00%) 
Hernia obstructive  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Hepatobiliary disorders       
Bile duct obstruction  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Cholangitis  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Infections and infestations       
Pneumonia  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Bacteraemia  1  0/20 (0.00%)  2/44 (4.55%)  0/3 (0.00%) 
Neutropenic sepsis  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Abdominal wall abscess  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Cellulitis  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Clostridium difficile colitis  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Endocarditis  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Infection  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Sepsis  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Urinary tract infection  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Medical device complication  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  2/20 (10.00%)  3/44 (6.82%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Nervous system disorders       
Loss of consciousness  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Cerebrovascular accident  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Convulsion  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Migraine with aura  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Sedation  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Syncope  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Psychiatric disorders       
Mental status changes  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Renal and urinary disorders       
Hydronephrosis  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Ureteric obstruction  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Respiratory failure  1  0/20 (0.00%)  1/44 (2.27%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
100 mg/m^2 125 mg/m^2 150 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   44/44 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  12/20 (60.00%)  30/44 (68.18%)  2/3 (66.67%) 
Bone marrow failure  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Leukopenia  1  4/20 (20.00%)  18/44 (40.91%)  2/3 (66.67%) 
Lymphadenitis  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Lymphadenopathy  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Neutropenia  1  10/20 (50.00%)  25/44 (56.82%)  2/3 (66.67%) 
Thrombocytopenia  1  5/20 (25.00%)  26/44 (59.09%)  2/3 (66.67%) 
Cardiac disorders       
Atrial fibrillation  1  1/20 (5.00%)  1/44 (2.27%)  1/3 (33.33%) 
Bradycardia  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Palpitations  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Tachycardia  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Ventricular extrasystoles  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  2/20 (10.00%)  0/44 (0.00%)  0/3 (0.00%) 
Hypoacusis  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Endocrine disorders       
Steroid withdrawal syndrome  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Eye disorders       
Blepharitis  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Conjunctival haemorrhage  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Conjunctivitis  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Diplopia  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Dry eye  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Eye swelling  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Vision blurred  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Visual impairment  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  4/20 (20.00%)  9/44 (20.45%)  1/3 (33.33%) 
Abdominal pain  1  7/20 (35.00%)  17/44 (38.64%)  2/3 (66.67%) 
Abdominal pain lower  1  3/20 (15.00%)  1/44 (2.27%)  0/3 (0.00%) 
Abdominal pain upper  1  2/20 (10.00%)  4/44 (9.09%)  0/3 (0.00%) 
Colitis  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Constipation  1  6/20 (30.00%)  21/44 (47.73%)  0/3 (0.00%) 
Diarrhoea  1  7/20 (35.00%)  23/44 (52.27%)  2/3 (66.67%) 
Dry mouth  1  3/20 (15.00%)  0/44 (0.00%)  0/3 (0.00%) 
Dyspepsia  1  0/20 (0.00%)  5/44 (11.36%)  0/3 (0.00%) 
Dysphagia  1  2/20 (10.00%)  1/44 (2.27%)  0/3 (0.00%) 
Eructation  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Faecal incontinence  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Flatulence  1  1/20 (5.00%)  2/44 (4.55%)  1/3 (33.33%) 
Gastrooesophageal reflux disease  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Haemorrhoids  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Hiatus hernia  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Impaired gastric emptying  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Melaena  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Mouth ulceration  1  1/20 (5.00%)  2/44 (4.55%)  1/3 (33.33%) 
Nausea  1  8/20 (40.00%)  29/44 (65.91%)  2/3 (66.67%) 
Odynophagia  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Oral mucosal erythema  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Oral pain  1  2/20 (10.00%)  1/44 (2.27%)  0/3 (0.00%) 
Retching  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Stomatitis  1  2/20 (10.00%)  1/44 (2.27%)  0/3 (0.00%) 
Vomiting  1  5/20 (25.00%)  20/44 (45.45%)  2/3 (66.67%) 
General disorders       
Asthenia  1  1/20 (5.00%)  7/44 (15.91%)  1/3 (33.33%) 
Catheter related complication  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Catheter site inflammation  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Chest discomfort  1  2/20 (10.00%)  1/44 (2.27%)  0/3 (0.00%) 
Chest pain  1  2/20 (10.00%)  3/44 (6.82%)  1/3 (33.33%) 
Chills  1  5/20 (25.00%)  10/44 (22.73%)  1/3 (33.33%) 
Fatigue  1  15/20 (75.00%)  39/44 (88.64%)  3/3 (100.00%) 
Influenza like illness  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Infusion site pain  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Injection site extravasation  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Local swelling  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Malaise  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Mucosal dryness  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Mucosal inflammation  1  1/20 (5.00%)  11/44 (25.00%)  1/3 (33.33%) 
Oedema peripheral  1  7/20 (35.00%)  27/44 (61.36%)  1/3 (33.33%) 
Pain  1  3/20 (15.00%)  4/44 (9.09%)  0/3 (0.00%) 
Pyrexia  1  8/20 (40.00%)  20/44 (45.45%)  1/3 (33.33%) 
Hepatobiliary disorders       
Bile duct obstruction  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Hyperbilirubinaemia  1  1/20 (5.00%)  1/44 (2.27%)  1/3 (33.33%) 
Portal vein thrombosis  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Immune system disorders       
Seasonal allergy  1  2/20 (10.00%)  3/44 (6.82%)  0/3 (0.00%) 
Infections and infestations       
Candidiasis  1  2/20 (10.00%)  5/44 (11.36%)  0/3 (0.00%) 
Cellulitis  1  3/20 (15.00%)  5/44 (11.36%)  0/3 (0.00%) 
Folliculitis  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Fungal infection  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Infection  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Lobar pneumonia  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Localised infection  1  0/20 (0.00%)  1/44 (2.27%)  1/3 (33.33%) 
Oral candidiasis  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Pneumonia  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Rash pustular  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Sinusitis  1  3/20 (15.00%)  4/44 (9.09%)  0/3 (0.00%) 
Upper respiratory tract infection  1  0/20 (0.00%)  4/44 (9.09%)  0/3 (0.00%) 
Urinary tract infection  1  1/20 (5.00%)  7/44 (15.91%)  0/3 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Incision site complication  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Medical device pain  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Nail avulsion  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Post-traumatic pain  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Procedural pain  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Procedural site reaction  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Stent occlusion  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Sunburn  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  6/20 (30.00%)  4/44 (9.09%)  0/3 (0.00%) 
Aspartate aminotransferase increased  1  5/20 (25.00%)  3/44 (6.82%)  0/3 (0.00%) 
Blood albumin decreased  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Blood alkaline phosphatase increased  1  4/20 (20.00%)  1/44 (2.27%)  0/3 (0.00%) 
Blood creatinine increased  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Blood urine present  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Neutrophil count decreased  1  0/20 (0.00%)  9/44 (20.45%)  0/3 (0.00%) 
Platelet count decreased  1  1/20 (5.00%)  1/44 (2.27%)  1/3 (33.33%) 
Weight decreased  1  2/20 (10.00%)  8/44 (18.18%)  1/3 (33.33%) 
Weight increased  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  9/20 (45.00%)  22/44 (50.00%)  2/3 (66.67%) 
Dehydration  1  6/20 (30.00%)  12/44 (27.27%)  2/3 (66.67%) 
Hyperglycaemia  1  0/20 (0.00%)  4/44 (9.09%)  1/3 (33.33%) 
Hypoalbuminaemia  1  2/20 (10.00%)  4/44 (9.09%)  1/3 (33.33%) 
Hypocalcaemia  1  1/20 (5.00%)  0/44 (0.00%)  1/3 (33.33%) 
Hypoglycaemia  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Hypokalaemia  1  2/20 (10.00%)  12/44 (27.27%)  1/3 (33.33%) 
Hypomagnesaemia  1  1/20 (5.00%)  4/44 (9.09%)  1/3 (33.33%) 
Hyponatraemia  1  2/20 (10.00%)  4/44 (9.09%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/20 (10.00%)  10/44 (22.73%)  0/3 (0.00%) 
Back pain  1  2/20 (10.00%)  5/44 (11.36%)  0/3 (0.00%) 
Bone pain  1  2/20 (10.00%)  2/44 (4.55%)  1/3 (33.33%) 
Bunion  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Flank pain  1  1/20 (5.00%)  1/44 (2.27%)  1/3 (33.33%) 
Joint contracture  1  0/20 (0.00%)  0/44 (0.00%)  1/3 (33.33%) 
Muscle spasms  1  0/20 (0.00%)  1/44 (2.27%)  1/3 (33.33%) 
Muscular weakness  1  2/20 (10.00%)  3/44 (6.82%)  0/3 (0.00%) 
Musculoskeletal chest pain  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Musculoskeletal pain  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Musculoskeletal stiffness  1  0/20 (0.00%)  4/44 (9.09%)  0/3 (0.00%) 
Myalgia  1  0/20 (0.00%)  10/44 (22.73%)  1/3 (33.33%) 
Neck pain  1  1/20 (5.00%)  3/44 (6.82%)  1/3 (33.33%) 
Pain in extremity  1  4/20 (20.00%)  9/44 (20.45%)  0/3 (0.00%) 
Nervous system disorders       
Balance disorder  1  2/20 (10.00%)  3/44 (6.82%)  0/3 (0.00%) 
Burning sensation  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Cognitive disorder  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Dizziness  1  8/20 (40.00%)  13/44 (29.55%)  2/3 (66.67%) 
Dysarthria  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Dysgeusia  1  3/20 (15.00%)  16/44 (36.36%)  2/3 (66.67%) 
Head discomfort  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Headache  1  7/20 (35.00%)  9/44 (20.45%)  1/3 (33.33%) 
Hypoaesthesia  1  1/20 (5.00%)  4/44 (9.09%)  0/3 (0.00%) 
Migraine  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Neuropathy peripheral  1  5/20 (25.00%)  29/44 (65.91%)  2/3 (66.67%) 
Paraesthesia  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Peripheral motor neuropathy  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Peripheral nerve palsy  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Peripheral sensory neuropathy  1  3/20 (15.00%)  3/44 (6.82%)  0/3 (0.00%) 
Sinus headache  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Somnolence  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Syncope  1  1/20 (5.00%)  2/44 (4.55%)  1/3 (33.33%) 
Psychiatric disorders       
Agitation  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Anxiety  1  2/20 (10.00%)  13/44 (29.55%)  0/3 (0.00%) 
Confusional state  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Depressed mood  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Depression  1  1/20 (5.00%)  8/44 (18.18%)  0/3 (0.00%) 
Insomnia  1  7/20 (35.00%)  13/44 (29.55%)  0/3 (0.00%) 
Restlessness  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders       
Bladder spasm  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Dysuria  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Haematuria  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Incontinence  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Proteinuria  1  1/20 (5.00%)  2/44 (4.55%)  0/3 (0.00%) 
Renal pain  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Urinary incontinence  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Urinary tract disorder  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Reproductive system and breast disorders       
Breast pain  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/20 (25.00%)  13/44 (29.55%)  0/3 (0.00%) 
Dyspnoea  1  7/20 (35.00%)  11/44 (25.00%)  1/3 (33.33%) 
Dyspnoea exertional  1  1/20 (5.00%)  4/44 (9.09%)  1/3 (33.33%) 
Epistaxis  1  2/20 (10.00%)  10/44 (22.73%)  0/3 (0.00%) 
Hypoxia  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Lung infiltration  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Nasal congestion  1  2/20 (10.00%)  1/44 (2.27%)  0/3 (0.00%) 
Oropharyngeal pain  1  1/20 (5.00%)  6/44 (13.64%)  0/3 (0.00%) 
Pleural effusion  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Rhinorrhoea  1  2/20 (10.00%)  6/44 (13.64%)  0/3 (0.00%) 
Wheezing  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  15/20 (75.00%)  35/44 (79.55%)  1/3 (33.33%) 
Decubitus ulcer  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Dry skin  1  2/20 (10.00%)  3/44 (6.82%)  1/3 (33.33%) 
Erythema  1  1/20 (5.00%)  10/44 (22.73%)  1/3 (33.33%) 
Hyperhidrosis  1  1/20 (5.00%)  5/44 (11.36%)  1/3 (33.33%) 
Nail discolouration  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Nail disorder  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Night sweats  1  4/20 (20.00%)  1/44 (2.27%)  0/3 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Petechiae  1  0/20 (0.00%)  1/44 (2.27%)  1/3 (33.33%) 
Pruritus  1  5/20 (25.00%)  10/44 (22.73%)  0/3 (0.00%) 
Rash  1  7/20 (35.00%)  22/44 (50.00%)  2/3 (66.67%) 
Skin hyperpigmentation  1  1/20 (5.00%)  1/44 (2.27%)  0/3 (0.00%) 
Skin lesion  1  0/20 (0.00%)  3/44 (6.82%)  0/3 (0.00%) 
Urticaria  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Surgical and medical procedures       
Biliary drainage  1  1/20 (5.00%)  0/44 (0.00%)  0/3 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  0/20 (0.00%)  5/44 (11.36%)  0/3 (0.00%) 
Flushing  1  2/20 (10.00%)  2/44 (4.55%)  0/3 (0.00%) 
Hypertension  1  1/20 (5.00%)  3/44 (6.82%)  0/3 (0.00%) 
Hypotension  1  3/20 (15.00%)  5/44 (11.36%)  0/3 (0.00%) 
Orthostatic hypotension  1  2/20 (10.00%)  6/44 (13.64%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
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.
Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to their submission; Celgene shall complete its review within 30 days after receipt. Upon Celgene’s request, proposed publication or presentation can be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00398086     History of Changes
Other Study ID Numbers: CA040
First Submitted: November 8, 2006
First Posted: November 10, 2006
Results First Submitted: June 14, 2013
Results First Posted: August 21, 2013
Last Update Posted: April 25, 2016