Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer (TOP0602)

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: NCT00509366
Recruitment Status : Terminated (Study terminated due to reproducibility issues with genomics prediction model.)
First Posted : July 31, 2007
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Drug: Cisplatin & Gemcitabine
Drug: Cisplatin & Pemetrexed
Drug: Docetaxel & Gemcitabine
Drug: Pemetrexed & Gemcitabine
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cisplatin + Gemcitabine Cisplatin + Pemetrexed Pemetrexed + Gemcitabine Docetaxel + Gemcitabine Screen Failure
Hide Arm/Group Description Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure. Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure. Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure. Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology. Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
Period Title: Overall Study
Started 18 [1] 8 [2] 22 [3] 2 [4] 51 [5]
Assigned Treatment 18 [6] 8 [7] 22 [8] 2 [9] 0
Completed 17 [10] 7 [11] 21 [12] 2 [13] 51 [14]
Not Completed 1 1 1 0 0
Reason Not Completed
Not Treated (Screen Failure)             1             1             1             0             0
[1]
Registered patients who were assigned cisplatin/gemcitabine treatment.
[2]
Registered patients who were assigned cisplatin/pemetrexed treatment.
[3]
Registered patients who were assigned pemetrexed/gemcitabine treatment.
[4]
Registered patients who were assigned docetaxel/gemcitabine treatment.
[5]
Registered patients who were neither assigned nor treated with protocol-based therapy.
[6]
Patients who were assigned to cisplatin/gemcitabine treatment arm.
[7]
Patients who were assigned to cisplatin/pemetrexed treatment arm.
[8]
Patients who were assigned to pemetrexed/gemcitabine treatment arm.
[9]
Patients who were assigned to docetaxel/gemcitabine treatment arm.
[10]
Patients assigned to treatment and treated with cisplatin/gemcitabine treatment combination.
[11]
Patients assigned to treatment and treated with cisplatin/pemetrexed treatment combination.
[12]
Patients assigned to treatment and treated with pemetrexed/gemcitabine treatment combination.
[13]
Patients assigned to treatment and treated with docetaxel/gemcitabine treatment combination.
[14]
Patients who were neither assigned nor treated with protocol-based therapy.
Arm/Group Title Cisplatin + Gemcitabine Cisplatin + Pemetrexed Pemetrexed + Gemcitabine Docetaxel + Gemcitabine Screen Failure Total
Hide Arm/Group Description Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study. Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study. Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study. Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study. Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility. Total of all reporting groups
Overall Number of Baseline Participants 17 7 21 2 54 101
Hide Baseline Analysis Population Description
The number of participants in each group reflects the number of participants at the end of the study period (COMPLETED) in the Participant Flow Analysis, with the exception of 3 patients who were assigned treatment, but not treated, and were added to the number of screen failures.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 7 participants 21 participants 2 participants 54 participants 101 participants
62.53  (6.51) 61.43  (9.78) 62.14  (9.72) 59.00  (7.07) 61.24  (10.10) 61.61  (9.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 7 participants 21 participants 2 participants 54 participants 101 participants
Female
6
  35.3%
5
  71.4%
9
  42.9%
0
   0.0%
20
  37.0%
40
  39.6%
Male
11
  64.7%
2
  28.6%
12
  57.1%
2
 100.0%
34
  63.0%
61
  60.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 7 participants 21 participants 2 participants 54 participants 101 participants
17 7 21 2 54 101
1.Primary Outcome
Title 1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients
Hide Description One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of treated patients
19.15
(9.46 to 31.40)
2.Secondary Outcome
Title Median Time to Progressive Disease
Hide Description Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
4.60
(3.58 to 6.47)
3.Secondary Outcome
Title Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
Hide Description The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.
Time Frame Baseline, Every 21 days for a maximum of 6 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
Change from baseline to Cycle 1 0.15  (1.76)
Change from baseline to Cycle 2 -1.04  (2.23)
Change from baseline to Cycle 3 -1.28  (2.97)
Change from baseline to Cycle 4 -2.62  (2.48)
Change from baseline to Cycle 5 -6.14  (3.96)
Change from baseline to Cycle 6 -0.72  (3.20)
4.Secondary Outcome
Title Drug Sensitivity Quartiles for Cisplatin and Pemetrexed
Hide Description Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame May 2007 to December 2011
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cisplatin Sensitive (Pre-Amendment) Cisplatin Sensitive (Post-Amendment) Cisplatin Resistant (Pre-Amendment) Cisplatin Resistant (Post-Amendment) Screen Failure
Hide Arm/Group Description Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010. Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010. Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010. Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010. Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
All-Cause Mortality
Cisplatin Sensitive (Pre-Amendment) Cisplatin Sensitive (Post-Amendment) Cisplatin Resistant (Pre-Amendment) Cisplatin Resistant (Post-Amendment) Screen Failure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cisplatin Sensitive (Pre-Amendment) Cisplatin Sensitive (Post-Amendment) Cisplatin Resistant (Pre-Amendment) Cisplatin Resistant (Post-Amendment) Screen Failure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/16 (50.00%)   5/8 (62.50%)   12/17 (70.59%)   4/6 (66.67%)   3/45 (6.67%) 
Blood and lymphatic system disorders           
Anemia  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Febrile neutropenia  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Cardiac disorders           
Asystole  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Atrial flutter  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Cardiac disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Sinus tachycardia  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Gastrointestinal disorders           
Constipation  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Diarrhea  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Nausea  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Upper gastrointestinal hemorrhage  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Vomiting  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
General disorders           
Fatigue  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Fever  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  2/6 (33.33%)  0/45 (0.00%) 
Injection site reaction  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Immune system disorders           
Allergic reaction  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Infections and infestations           
Bronchial infection  1  0/16 (0.00%)  1/8 (12.50%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Vagina  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Lung infection  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Upper respiratory infection  1  0/16 (0.00%)  2/8 (25.00%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Urinary tract infection  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Injury, poisoning and procedural complications           
Aortic injury  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Fracture  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Investigations           
Neutrophil count decreased  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Metabolism and nutrition disorders           
Acidosis  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Dehydration  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Hyponatremia  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Nervous system disorders           
Ischemia cerebrovascular  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Nervous system disorders - Other  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Psychiatric disorders           
Confusion  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Renal and urinary disorders           
Acute kidney injury  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Bronchopulmonary hemorrhage  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Dyspnea  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Pleural effusion  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Pneumonitis  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Pneumothorax  1  1/16 (6.25%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  3/45 (6.67%) 
Respiratory, thoracic and mediastinal disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Vascular disorders           
Thromboembolic event  1  2/16 (12.50%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cisplatin Sensitive (Pre-Amendment) Cisplatin Sensitive (Post-Amendment) Cisplatin Resistant (Pre-Amendment) Cisplatin Resistant (Post-Amendment) Screen Failure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   8/8 (100.00%)   17/17 (100.00%)   6/6 (100.00%)   3/45 (6.67%) 
Blood and lymphatic system disorders           
Anemia  1  14/16 (87.50%)  6/8 (75.00%)  15/17 (88.24%)  6/6 (100.00%)  0/45 (0.00%) 
Blood and lymphatic system disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  3/17 (17.65%)  1/6 (16.67%)  0/45 (0.00%) 
Febrile neutropenia  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Atrial flutter  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Cardiac disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Left ventricular systolic dysfunction  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Myocardial infarction  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Palpitations  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Sinus tachycardia  1  0/16 (0.00%)  2/8 (25.00%)  3/17 (17.65%)  2/6 (33.33%)  0/45 (0.00%) 
Supraventricular tachycardia  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Ventricular arrhythmia  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Ear and labyrinth disorders           
Ear and labyrinth disorders - Other  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
External ear inflammation  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Hearing impaired  1  3/16 (18.75%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Middle ear inflammation  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Tinnitus  1  7/16 (43.75%)  3/8 (37.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Eye disorders           
Blurred vision  1  3/16 (18.75%)  0/8 (0.00%)  4/17 (23.53%)  1/6 (16.67%)  0/45 (0.00%) 
Dry eye  1  1/16 (6.25%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Extraocular muscle paresis  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Eye disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Eye pain  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Flashing lights  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Watering eyes  1  1/16 (6.25%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Gastrointestinal disorders           
Abdominal distension  1  1/16 (6.25%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Abdominal pain  1  3/16 (18.75%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Ascites  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Colitis  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Constipation  1  6/16 (37.50%)  7/8 (87.50%)  12/17 (70.59%)  2/6 (33.33%)  0/45 (0.00%) 
Diarrhea  1  6/16 (37.50%)  2/8 (25.00%)  6/17 (35.29%)  4/6 (66.67%)  0/45 (0.00%) 
Dry mouth  1  0/16 (0.00%)  0/8 (0.00%)  4/17 (23.53%)  0/6 (0.00%)  0/45 (0.00%) 
Dyspepsia  1  3/16 (18.75%)  2/8 (25.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Dysphagia  1  3/16 (18.75%)  1/8 (12.50%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Flatulence  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  2/6 (33.33%)  0/45 (0.00%) 
Gastritis  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Gastrointestinal disorders - Other  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Hemorrhoidal hemorrhage  1  0/16 (0.00%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Hemorrhoids  1  1/16 (6.25%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Mucositis oral  1  4/16 (25.00%)  2/8 (25.00%)  6/17 (35.29%)  3/6 (50.00%)  0/45 (0.00%) 
Nausea  1  13/16 (81.25%)  8/8 (100.00%)  12/17 (70.59%)  2/6 (33.33%)  0/45 (0.00%) 
Oral hemorrhage  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Rectal hemorrhage  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Rectal pain  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Stomach pain  1  1/16 (6.25%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Vomiting  1  9/16 (56.25%)  6/8 (75.00%)  4/17 (23.53%)  0/6 (0.00%)  0/45 (0.00%) 
General disorders           
Chills  1  3/16 (18.75%)  2/8 (25.00%)  4/17 (23.53%)  2/6 (33.33%)  0/45 (0.00%) 
Edema face  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Edema limbs  1  7/16 (43.75%)  2/8 (25.00%)  10/17 (58.82%)  2/6 (33.33%)  0/45 (0.00%) 
Edema trunk  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Fatigue  1  13/16 (81.25%)  7/8 (87.50%)  15/17 (88.24%)  5/6 (83.33%)  0/45 (0.00%) 
Fever  1  3/16 (18.75%)  3/8 (37.50%)  9/17 (52.94%)  4/6 (66.67%)  0/45 (0.00%) 
General disorders and administration site conditions - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Injection site reaction  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Non-cardiac chest pain  1  2/16 (12.50%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Pain  1  0/16 (0.00%)  2/8 (25.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Immune system disorders           
Allergic reaction  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Immune system disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Infections and infestations           
Bronchial infection  1  0/16 (0.00%)  1/8 (12.50%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Conjunctivitis infective  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Eye infection  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Gum infection  1  1/16 (6.25%)  0/8 (0.00%)  3/17 (17.65%)  1/6 (16.67%)  0/45 (0.00%) 
Infections and infestations - Other  1  0/16 (0.00%)  1/8 (12.50%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Infections and infestations-Infection with Grade 3 or 4 neutrophils: Skin (cellulitis)  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Joint infection  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Lung infection  1  3/16 (18.75%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Mucosal infection  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Otitis media  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Sepsis  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Sinusitis  1  2/16 (12.50%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Skin infection  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Upper respiratory infection  1  0/16 (0.00%)  2/8 (25.00%)  0/17 (0.00%)  2/6 (33.33%)  0/45 (0.00%) 
Urinary tract infection  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Injury, poisoning and procedural complications           
Aortic injury  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Bruising  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  5/16 (31.25%)  2/8 (25.00%)  14/17 (82.35%)  4/6 (66.67%)  0/45 (0.00%) 
Alkaline phosphatase increased  1  7/16 (43.75%)  4/8 (50.00%)  11/17 (64.71%)  3/6 (50.00%)  0/45 (0.00%) 
Aspartate aminotransferase increased  1  6/16 (37.50%)  1/8 (12.50%)  10/17 (58.82%)  5/6 (83.33%)  0/45 (0.00%) 
Blood bilirubin increased  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Creatinine increased  1  9/16 (56.25%)  4/8 (50.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Investigations - Other  1  1/16 (6.25%)  4/8 (50.00%)  2/17 (11.76%)  2/6 (33.33%)  0/45 (0.00%) 
Lipase increased  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Lymphocyte count decreased  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  2/6 (33.33%)  0/45 (0.00%) 
Neutrophil count decreased  1  11/16 (68.75%)  4/8 (50.00%)  12/17 (70.59%)  6/6 (100.00%)  0/45 (0.00%) 
Platelet count decreased  1  9/16 (56.25%)  5/8 (62.50%)  8/17 (47.06%)  4/6 (66.67%)  0/45 (0.00%) 
Weight gain  1  2/16 (12.50%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Weight loss  1  4/16 (25.00%)  2/8 (25.00%)  4/17 (23.53%)  3/6 (50.00%)  0/45 (0.00%) 
White blood cell decreased  1  9/16 (56.25%)  3/8 (37.50%)  12/17 (70.59%)  6/6 (100.00%)  0/45 (0.00%) 
Metabolism and nutrition disorders           
Acidosis  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Anorexia  1  12/16 (75.00%)  5/8 (62.50%)  9/17 (52.94%)  3/6 (50.00%)  0/45 (0.00%) 
Dehydration  1  5/16 (31.25%)  2/8 (25.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Hypercalcemia  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Hyperglycemia  1  12/16 (75.00%)  6/8 (75.00%)  14/17 (82.35%)  4/6 (66.67%)  0/45 (0.00%) 
Hyperkalemia  1  2/16 (12.50%)  0/8 (0.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Hypermagnesemia  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Hypernatremia  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Hypoalbuminemia  1  14/16 (87.50%)  5/8 (62.50%)  14/17 (82.35%)  6/6 (100.00%)  0/45 (0.00%) 
Hypocalcemia  1  14/16 (87.50%)  5/8 (62.50%)  11/17 (64.71%)  4/6 (66.67%)  0/45 (0.00%) 
Hypoglycemia  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Hypokalemia  1  10/16 (62.50%)  5/8 (62.50%)  5/17 (29.41%)  1/6 (16.67%)  0/45 (0.00%) 
Hypomagnesemia  1  6/16 (37.50%)  4/8 (50.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Hyponatremia  1  10/16 (62.50%)  5/8 (62.50%)  9/17 (52.94%)  6/6 (100.00%)  0/45 (0.00%) 
Hypophosphatemia  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  3/16 (18.75%)  2/8 (25.00%)  2/17 (11.76%)  2/6 (33.33%)  0/45 (0.00%) 
Arthritis  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Back pain  1  3/16 (18.75%)  3/8 (37.50%)  4/17 (23.53%)  1/6 (16.67%)  0/45 (0.00%) 
Bone pain  1  0/16 (0.00%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Chest wall pain  1  2/16 (12.50%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Generalized muscle weakness  1  1/16 (6.25%)  2/8 (25.00%)  3/17 (17.65%)  1/6 (16.67%)  0/45 (0.00%) 
Muscle weakness lower limb  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  2/6 (33.33%)  0/45 (0.00%) 
Muscle weakness upper limb  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorder - Other  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Myalgia  1  3/16 (18.75%)  2/8 (25.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Neck pain  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Pain in extremity  1  3/16 (18.75%)  3/8 (37.50%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Nervous system disorders           
Dizziness  1  6/16 (37.50%)  1/8 (12.50%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Dysgeusia  1  11/16 (68.75%)  3/8 (37.50%)  7/17 (41.18%)  2/6 (33.33%)  0/45 (0.00%) 
Extrapyramidal disorder  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Facial nerve disorder  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Headache  1  6/16 (37.50%)  2/8 (25.00%)  6/17 (35.29%)  0/6 (0.00%)  0/45 (0.00%) 
Memory impairment  1  1/16 (6.25%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Nervous system disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Neuralgia  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Olfactory nerve disorder  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Peripheral motor neuropathy  1  9/16 (56.25%)  0/8 (0.00%)  5/17 (29.41%)  0/6 (0.00%)  0/45 (0.00%) 
Peripheral sensory neuropathy  1  7/16 (43.75%)  3/8 (37.50%)  4/17 (23.53%)  3/6 (50.00%)  0/45 (0.00%) 
Syncope  1  0/16 (0.00%)  2/8 (25.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Tremor  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Psychiatric disorders           
Agitation  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Anxiety  1  1/16 (6.25%)  1/8 (12.50%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Confusion  1  0/16 (0.00%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Depression  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Insomnia  1  8/16 (50.00%)  6/8 (75.00%)  4/17 (23.53%)  3/6 (50.00%)  0/45 (0.00%) 
Personality change  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Renal and urinary disorders           
Acute kidney injury  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Renal and urinary disorders - Other  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Urinary frequency  1  1/16 (6.25%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Urinary incontinence  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Reproductive system and breast disorders           
Pelvic pain  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Adult respiratory distress syndrome  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Allergic rhinitis  1  4/16 (25.00%)  0/8 (0.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Atelectasis  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Bronchopulmonary hemorrhage  1  3/16 (18.75%)  1/8 (12.50%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Bronchospasm  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Cough  1  3/16 (18.75%)  3/8 (37.50%)  5/17 (29.41%)  2/6 (33.33%)  0/45 (0.00%) 
Dyspnea  1  10/16 (62.50%)  7/8 (87.50%)  11/17 (64.71%)  4/6 (66.67%)  0/45 (0.00%) 
Epistaxis  1  3/16 (18.75%)  4/8 (50.00%)  2/17 (11.76%)  1/6 (16.67%)  0/45 (0.00%) 
Hiccups  1  2/16 (12.50%)  2/8 (25.00%)  2/17 (11.76%)  0/6 (0.00%)  0/45 (0.00%) 
Hypoxia  1  3/16 (18.75%)  2/8 (25.00%)  4/17 (23.53%)  1/6 (16.67%)  0/45 (0.00%) 
Pharyngeal mucositis  1  0/16 (0.00%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Pharyngolaryngeal pain  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Pleural effusion  1  0/16 (0.00%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Pneumonitis  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Pneumothorax  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  0/6 (0.00%)  3/45 (6.67%) 
Respiratory, thoracic and mediastinal disorders - Other  1  0/16 (0.00%)  1/8 (12.50%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Voice alteration  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  1/6 (16.67%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  12/16 (75.00%)  5/8 (62.50%)  8/17 (47.06%)  3/6 (50.00%)  0/45 (0.00%) 
Hyperhidrosis  1  1/16 (6.25%)  1/8 (12.50%)  3/17 (17.65%)  2/6 (33.33%)  0/45 (0.00%) 
Pruritus  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  2/6 (33.33%)  0/45 (0.00%) 
Purpura  1  0/16 (0.00%)  0/8 (0.00%)  0/17 (0.00%)  1/6 (16.67%)  0/45 (0.00%) 
Rash acneiform  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Rash maculo-papular  1  6/16 (37.50%)  2/8 (25.00%)  11/17 (64.71%)  3/6 (50.00%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders - Other  1  0/16 (0.00%)  0/8 (0.00%)  2/17 (11.76%)  2/6 (33.33%)  0/45 (0.00%) 
Skin ulceration  1  0/16 (0.00%)  0/8 (0.00%)  3/17 (17.65%)  0/6 (0.00%)  0/45 (0.00%) 
Vascular disorders           
Hypertension  1  1/16 (6.25%)  0/8 (0.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Hypotension  1  3/16 (18.75%)  0/8 (0.00%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Phlebitis  1  1/16 (6.25%)  1/8 (12.50%)  1/17 (5.88%)  0/6 (0.00%)  0/45 (0.00%) 
Thromboembolic event  1  0/16 (0.00%)  2/8 (25.00%)  0/17 (0.00%)  0/6 (0.00%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The microarray-based prediction model of chemotherapy sensitivity, used to allocate patients into the cisplatin treatment arms, was irreproducible and inaccurate. Quality of life measurements were incomplete and could not be analyzed.
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
Layout table for Results Point of Contact information
Name/Title: Neal Ready, MD, PhD
Organization: Duke University
Phone: 919-681-6932
EMail: neal.ready@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00509366    
Other Study ID Numbers: Pro00004599
First Submitted: July 30, 2007
First Posted: July 31, 2007
Results First Submitted: May 7, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014