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Trial record 2 of 16 for:    11784875 [PUBMED-IDS]

Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer

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: NCT00923273
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : October 23, 2013
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: FDG-PET
Drug: Pemetrexed
Drug: Sirolimus
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic acid tablets
Drug: Dexamethasone tablets
Enrollment 42
Recruitment Details  
Pre-assignment Details DL5 wasn’t tolerated. We expanded DL4, had 1 DLT of gr. 3 infection that was possibly related to study drugs or his cancer and declining health. The last subject on DL4 had gr. 4 neutropenia that lasted <7days. We believe this wasn’t significant and a lack of foresight to add length of neutropenia as DLT. IRB allowed DL4 with DLT stopping rule.
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10mg Load Treatment Level 5: 15mg Load
Hide Arm/Group Description Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
Period Title: Phase I Treatment Period
Started 4 [1] 3 [2] 3 [2] 7 [3] 5 [4]
Completed 4 3 3 7 5
Not Completed 0 0 0 0 0
[1]
The phase I portion will establish the maximum tolerated dose. 4 subjects peme naive.
[2]
3 subjects peme naive.
[3]
3 subjects initially enrolled and 4 subjects added after dose level 5; peme naive.
[4]
5 subjects peme naive.
Period Title: Phase II Treatment Period
Started 0 [1] 0 0 27 [2] 0
Completed 0 0 0 20 0
Not Completed 0 0 0 7 0
Reason Not Completed
NE-brain mets/met disease prior enrollmt             0             0             0             1             0
NE-not complete 2Cy trmt/no imaging done             0             0             0             6             0
[1]
The phase II portion will utilize the MTD from the phase I portion.
[2]
Includes 8 subjects with prior peme;12 subjects who were peme naive; 7 subjects rolled over from phI
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load Total
Hide Arm/Group Description Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 Total of all reporting groups
Overall Number of Baseline Participants 4 3 3 27 5 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
0
   0.0%
1
  33.3%
18
  66.7%
4
  80.0%
25
  59.5%
>=65 years
2
  50.0%
3
 100.0%
2
  66.7%
9
  33.3%
1
  20.0%
17
  40.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
64.65  (7.84) 71.57  (3.76) 61.7  (24.74) 59.5  (11.48) 56.08  (10.75) 60.6  (11.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
Female
2
  50.0%
2
  66.7%
1
  33.3%
14
  51.9%
2
  40.0%
21
  50.0%
Male
2
  50.0%
1
  33.3%
2
  66.7%
13
  48.1%
3
  60.0%
21
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
1
  33.3%
2
   7.4%
0
   0.0%
4
   9.5%
Not Hispanic or Latino
4
 100.0%
2
  66.7%
2
  66.7%
25
  92.6%
5
 100.0%
38
  90.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
1
  33.3%
4
  14.8%
0
   0.0%
6
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  33.3%
1
  33.3%
4
  14.8%
0
   0.0%
6
  14.3%
White
4
 100.0%
0
   0.0%
1
  33.3%
18
  66.7%
5
 100.0%
28
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  33.3%
0
   0.0%
1
   3.7%
0
   0.0%
2
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 3 participants 27 participants 5 participants 42 participants
4 3 3 27 5 42
1.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed
Hide Description The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.
Time Frame 5 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10mg Load Treatment Level 5: 15mg Load
Hide Arm/Group Description:
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Overall Number of Participants Analyzed 4 3 3 7 5
Measure Type: Number
Unit of Measure: mg/m^2
500 500 500 500 500
2.Primary Outcome
Title Phase II: Clinical Response Rate
Hide Description Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame 21 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.
Arm/Group Title Treatment Level 4: 10mg Load
Hide Arm/Group Description:

Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2

Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
Complete response 0
Partial response 5
Stable disease 13
Progressive disease 2
Not evaluable 7
3.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Sirolimus
Hide Description The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.
Time Frame 5 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10mg Load Treatment Level 5: 15mg Load
Hide Arm/Group Description:
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
Overall Number of Participants Analyzed 4 3 3 7 5
Measure Type: Number
Unit of Measure: mg/m^2
10 10 10 10 10
4.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load
Hide Arm/Group Description:
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
Overall Number of Participants Analyzed 4 3 3 7 5
Measure Type: Number
Unit of Measure: Participants
Subjects from phase I 4 3 3 7 5
8subjects prior peme & 12 subjects peme naive 0 0 0 20 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load
Hide Arm/Group Description Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
All-Cause Mortality
Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      1/3 (33.33%)      0/3 (0.00%)      7/27 (25.93%)      1/5 (20.00%)    
Blood and lymphatic system disorders           
Edema: limb  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Lymphopenia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  2
Neutrophils/granulocytes (ANC/AGC)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
CD4 count  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders           
Nausea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 0/5 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  4 0/5 (0.00%)  0
Constipation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
General disorders           
Fatigue (asthenia, lethargy, malaise)  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Death not associated with CTCAE term: Disease progression NOS  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infections and infestations           
Febrile neutropenia  1 [1]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection  1 [2]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: lung (pneumonia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Metabolism and nutrition disorders           
Magnesium, serum-high (hypermagnesemia)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 1/5 (20.00%)  1
Cholesterol, serum-high (hypercholesteremia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Creatinine  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Triglyceride, serum-high (hypertriglyceridemia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Magnesium, serum-low (hypomagnesemia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders           
Somnolence/depressed level of consciousness  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Hypoxia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Pulmonary/Upper respiratory - Other (specify, pulmonary infiltrate, right lung)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Bronchospasm, wheezing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[2]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0x10e9/L): lung (pneumonia)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Level 1: 3mg Load Treatment Level 2: 6mg Load Treatment Level 3: 6mg Load Treatment Level 4: 10 mg Load Treatment Level 5: 15mg Load
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      27/27 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders           
Edema: limb  1  1/4 (25.00%)  4 1/3 (33.33%)  1 0/3 (0.00%)  0 4/27 (14.81%)  4 2/5 (40.00%)  3
Edema: trunk/genital  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Leukocytes (total WBC)  1  1/4 (25.00%)  7 2/3 (66.67%)  4 3/3 (100.00%)  5 9/27 (33.33%)  23 2/5 (40.00%)  8
Lymphopenia  1  3/4 (75.00%)  14 2/3 (66.67%)  15 3/3 (100.00%)  3 17/27 (62.96%)  49 5/5 (100.00%)  29
Neutrophils/granulocytes (ANC/AGC)  1  1/4 (25.00%)  4 2/3 (66.67%)  2 2/3 (66.67%)  4 10/27 (37.04%)  20 2/5 (40.00%)  7
PTT (Partial thromboplastin time)  1  2/4 (50.00%)  6 1/3 (33.33%)  2 3/3 (100.00%)  11 3/27 (11.11%)  7 4/5 (80.00%)  7
Platelets  1  1/4 (25.00%)  7 2/3 (66.67%)  5 3/3 (100.00%)  4 9/27 (33.33%)  17 4/5 (80.00%)  9
CD4 count  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 15/27 (55.56%)  37 3/5 (60.00%)  4
INR (International Normalized Ratio of prothrombin time)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 0/5 (0.00%)  0
Edema: head and neck  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  7 0/5 (0.00%)  0
Cardiac disorders           
Supraventricular and nodal arrhythmia: sinus tachycardia  1  2/4 (50.00%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 4/27 (14.81%)  4 1/5 (20.00%)  1
Cardiac troponin I (cTnl)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Supraventricular and nodal arrhythmia: atrial fibrillation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 1/5 (20.00%)  1
Hypotension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/27 (7.41%)  2 0/5 (0.00%)  0
Cardiac arrhythmia (Other (Specify, tavhycardia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Hypertension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  4 0/5 (0.00%)  0
Ear and labyrinth disorders           
Auditory/Ear - Other (Specify, hearing loss right side)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Tinnitus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Auditory/Ear - Other (Specify, congestion R/ear)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Eye disorders           
Dry eye syndrome  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Watery eye (epiphora, tearing)  1  2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Ocular surface disease  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Pain: eye  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Vision-blurred vision  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 1/27 (3.70%)  1 0/5 (0.00%)  0
Uveitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 0/5 (0.00%)  0
Gastrointestinal disorders           
Anorexia  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 16/27 (59.26%)  19 4/5 (80.00%)  7
Constipation  1  1/4 (25.00%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0 2/27 (7.41%)  2 1/5 (20.00%)  2
Diarrhea  1  2/4 (50.00%)  4 0/3 (0.00%)  0 0/3 (0.00%)  0 13/27 (48.15%)  15 2/5 (40.00%)  2
Distention/bloating, abdominal  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Flatulence  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Gastrointestinal - Other (Specify, bloating)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Mucositis/stomatitis (clinical exam): oral cavity  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 6/27 (22.22%)  9 2/5 (40.00%)  2
Nausea  1  2/4 (50.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 14/27 (51.85%)  16 4/5 (80.00%)  5
Pain: Abdomen NOS  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 6/27 (22.22%)  8 0/5 (0.00%)  0
Pain: oral cavity  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Vomiting  1  1/4 (25.00%)  2 1/3 (33.33%)  3 1/3 (33.33%)  1 9/27 (33.33%)  13 3/5 (60.00%)  6
Pain: rectum  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/27 (0.00%)  0 0/5 (0.00%)  0
Ascites (non-malignant)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Dry mouth/salivary gland (xerostomia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Dysphagia (difficulty swallowing)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  6 0/5 (0.00%)  0
Mucositis/stomatitis (functional/symptomatic): oral cavity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/27 (14.81%)  4 0/5 (0.00%)  0
Pain: dental/teeth/periodontal  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Taste alteration (dysgeusia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  5 1/5 (20.00%)  1
Gastrointestinal - Other (Specify, early satiety)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Pain: Anus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Pain: Stomach  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/27 (0.00%)  0 0/5 (0.00%)  0
Dehydration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  3 3/5 (60.00%)  3
Esophagitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 0/5 (0.00%)  0
Heartburn/dyspepsia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  8 1/5 (20.00%)  1
General disorders           
Fatigue (asthenia, lethargy, malaise)  1  2/4 (50.00%)  3 1/3 (33.33%)  1 0/3 (0.00%)  0 18/27 (66.67%)  27 5/5 (100.00%)  13
Fever  1 [1]  2/4 (50.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 8/27 (29.63%)  9 1/5 (20.00%)  1
Insomnia  1  3/4 (75.00%)  4 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  3 2/5 (40.00%)  2
Pain - Other (Specify, L rib; R costal margin; shoulder)  1  2/4 (50.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Rigors/chills  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Sweating (diaphoresis)  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 2/27 (7.41%)  2 0/5 (0.00%)  0
Pain: Other (Specify)  1 [2]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  5 0/5 (0.00%)  0
Weight gain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Weight loss  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 7/27 (25.93%)  10 0/5 (0.00%)  0
Pain - Other (Specify, left elbow; left flank; left trunk)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  3
Immune system disorders           
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  3 1/5 (20.00%)  1
Infections and infestations           
Infection - Other (Specify, pneumonia)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils  1 [3]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection - Other (Specify, URI)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: bladder (urinary)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: oral cavity-gums (gingivitis)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  3 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: sinus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4  1 [4]  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Febrile neutropenia  1 [5]  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils: Rectum  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Infection with unknown ANC: Lung (pneumonia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Infection with unknown ANC: Skin (cellulitis)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Infection with unknown ANC: upper airway NOS  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders           
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/4 (25.00%)  7 2/3 (66.67%)  4 1/3 (33.33%)  1 6/27 (22.22%)  20 3/5 (60.00%)  13
AST/SGOT (serum glutamic oxaloacetic transaminase)  1  3/4 (75.00%)  9 2/3 (66.67%)  2 0/3 (0.00%)  0 5/27 (18.52%)  11 3/5 (60.00%)  10
Albumin, serum-low (hypoalbuminemia)  1  2/4 (50.00%)  11 3/3 (100.00%)  14 3/3 (100.00%)  8 7/27 (25.93%)  16 5/5 (100.00%)  13
Alkaline phosphatase  1  4/4 (100.00%)  7 2/3 (66.67%)  3 1/3 (33.33%)  2 3/27 (11.11%)  6 2/5 (40.00%)  5
Calcium, serum-high (hypercalcemia)  1  2/4 (50.00%)  5 1/3 (33.33%)  1 1/3 (33.33%)  2 3/27 (11.11%)  16 1/5 (20.00%)  1
Cholesterol, serum-high (hypercholesteremia)  1  1/4 (25.00%)  2 2/3 (66.67%)  3 1/3 (33.33%)  2 4/27 (14.81%)  10 2/5 (40.00%)  2
Creatinine  1  1/4 (25.00%)  8 1/3 (33.33%)  1 1/3 (33.33%)  1 3/27 (11.11%)  5 3/5 (60.00%)  12
GGT (gamma-Glutamyl transpeptidase)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Glomerular filtration rate  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  2
Glucose, serum-high (hyperglycemia)  1  1/4 (25.00%)  16 2/3 (66.67%)  2 1/3 (33.33%)  1 9/27 (33.33%)  32 4/5 (80.00%)  14
Glucose, serum-low (hypoglycemia)  1  1/4 (25.00%)  1 1/3 (33.33%)  2 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Hemoglobin  1  3/4 (75.00%)  23 3/3 (100.00%)  17 3/3 (100.00%)  6 12/27 (44.44%)  26 5/5 (100.00%)  34
Magnesium, serum-high (hypermagnesemia)  1  2/4 (50.00%)  3 1/3 (33.33%)  5 0/3 (0.00%)  0 5/27 (18.52%)  10 2/5 (40.00%)  2
Magnesium, serum-low (hypomagnesemia)  1  2/4 (50.00%)  8 1/3 (33.33%)  3 1/3 (33.33%)  2 11/27 (40.74%)  22 4/5 (80.00%)  10
Phosphate, serum-low (hypophosphatemia)  1  2/4 (50.00%)  14 2/3 (66.67%)  5 1/3 (33.33%)  2 13/27 (48.15%)  36 3/5 (60.00%)  7
Potassium, serum-low (hypokalemia)  1  1/4 (25.00%)  4 1/3 (33.33%)  5 0/3 (0.00%)  0 2/27 (7.41%)  4 2/5 (40.00%)  3
Proteinuria  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 2/5 (40.00%)  3
Sodium, serum-high (hypernatremia)  1  1/4 (25.00%)  3 0/3 (0.00%)  0 1/3 (33.33%)  1 0/27 (0.00%)  0 0/5 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  4/4 (100.00%)  6 2/3 (66.67%)  13 1/3 (33.33%)  2 11/27 (40.74%)  32 4/5 (80.00%)  11
Triglyceride, serum-high (hypertriglyceridemia)  1  1/4 (25.00%)  4 2/3 (66.67%)  2 1/3 (33.33%)  1 2/27 (7.41%)  4 1/5 (20.00%)  1
Uric acid, serum-high (hyperuricemia)  1  1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
CPK (creatine phosphokinase)  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/27 (7.41%)  3 0/5 (0.00%)  0
Bicarbonate, serum-low  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/27 (3.70%)  3 1/5 (20.00%)  1
Lipase  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  6 1/5 (20.00%)  1
Bilirubin (hyperbilirubinemia)  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  0/4 (0.00%)  0 1/3 (33.33%)  3 0/3 (0.00%)  0 3/27 (11.11%)  3 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Pain: Bone  1  1/4 (25.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Pain: extremity-limb  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Pain: back  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/27 (11.11%)  3 0/5 (0.00%)  0
Pain: joint  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 3/27 (11.11%)  4 0/5 (0.00%)  0
Muscle weakness, genralized or specific area (not due to neuropathy): extraocular  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Muscle weakness, genralized or specific area (not due to neuropathy): extremity-lower  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  4 0/5 (0.00%)  0
Muscle weakness, genralized or specific area (not due to neuropathy): whole body/generalized  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Pain: chest wall  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  8 1/5 (20.00%)  1
Pain: chest/thorax NOS  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Pain: muscle  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Nervous system disorders           
Cognitive disturbance  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Confusion  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 2/27 (7.41%)  2 0/5 (0.00%)  0
Mood alteration: anxiety  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 2/5 (40.00%)  2
Mood alteration: depression  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/27 (0.00%)  0 2/5 (40.00%)  2
Neuropathy: sensory  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 4/27 (14.81%)  4 1/5 (20.00%)  1
Somnolence/depressed level of consciousness  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Speech impairment (e.g., dysphagia or aphasia)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Tremor  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Dizziness  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/27 (7.41%)  2 2/5 (40.00%)  2
Pain: head/headache  1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 6/27 (22.22%)  6 2/5 (40.00%)  2
Seizure  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
CNS cerebrovascular ischemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/27 (0.00%)  0 0/5 (0.00%)  0
Pain: neuralgia/peripheral nerve  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Personality/behavioral  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Memory impairment  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/27 (7.41%)  3 0/5 (0.00%)  0
Mood alteration:agitation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Renal and urinary disorders           
Renal/Genitourinary - Other (Specify, renal insufficiency)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Urinary frequency/urgency  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/27 (14.81%)  4 0/5 (0.00%)  0
Renal/Genitourinary - Other (Specify, ARI)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Urine color change  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Renal failure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Hemoglobinuria  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 2/5 (40.00%)  2
Reproductive system and breast disorders           
Pain: pelvis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 6/27 (22.22%)  6 2/5 (40.00%)  3
Dyspnea (shortness of breath)  1  1/4 (25.00%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0 7/27 (25.93%)  10 3/5 (60.00%)  5
FEV(1)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Hemorrhage/Bleeding - Other (Specify, nose)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 4/27 (14.81%)  4 2/5 (40.00%)  2
Vital capacity  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Atelectasis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Bronchospasm, wheezing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  2 1/5 (20.00%)  1
Hiccoughs (hiccups, singultus)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Pain: throat/pharynx/larynx  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  7 2/5 (40.00%)  2
Voice changes/dysarthia (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Pulmonary/Upper respiratory - Other (Specify, mild drain. from podt throat)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Hemorrhage, pulmonary/upper respiratory:bronchopulmonary NOS  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Hypoxia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 6/27 (22.22%)  6 2/5 (40.00%)  3
Pleural effusion (non-malignant)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  5 1/5 (20.00%)  1
Pulmonary/Upper respiratory - Other (Specify, pulmonary infiltrates)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Hemorrhage, pulmonary/upper respiratory: nose  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 1/5 (20.00%)  1
Hemorrhage, pulmonary/upper respiratory: Bronchus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Obstruction/stenosis of airway: Bronchus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders           
Pruritis/itching  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 5/27 (18.52%)  5 1/5 (20.00%)  1
Rash/desquamation  1  1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 1/5 (20.00%)  1
Rash/acneiform  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 11/27 (40.74%)  12 2/5 (40.00%)  2
Photosensitivity  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/27 (0.00%)  0 0/5 (0.00%)  0
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Dermatology/Skin - Other (Specify, decubitus)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Nail changes  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 1/5 (20.00%)  1
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/27 (11.11%)  3 1/5 (20.00%)  1
Flushing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 1/5 (20.00%)  1
Hyperpigmentation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/27 (7.41%)  2 0/5 (0.00%)  0
Ulceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Vascular disorders           
Thrombosis/embolism (vascular access-related)  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/27 (0.00%)  0 1/5 (20.00%)  1
Thrombosis/thrombus/embolism  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/27 (3.70%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
(in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
[2]
chest pleuritic; left thigh; right rib; right shin; due to fall-hip
[3]
(ANC<1.0x10e9/L): oral cavity-gum (gingivitis)
[4]
neutrophils (ANC <1.0x10e9/L): urinary tract NOS
[5]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >=38.5 degrees C)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Arun Rajan
Organization: National Cancer Institute
Phone: 301-594-5322
Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923273     History of Changes
Obsolete Identifiers: NCT00636532
Other Study ID Numbers: 080078
08-C-0078
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: May 24, 2013
Results First Posted: October 23, 2013
Last Update Posted: October 2, 2015