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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00074005 | Other Identifier | Johns Hopkins Institutional Review Board | |
| HIC1601017054 | Other Identifier | Yale University |
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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipiodol | Other | Lipiodol, 10cc per TACE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol | Drug | Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR | 30 days, 90 days, and 180 days |
| Baseline Enhancing Tumor and Response by RECIST Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects. | 30 days, 90 days, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST): Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Schlachter, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Center | New Haven | Connecticut | 06510 | United States | ||
| The Johns Hopkins Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lipiodol | Lipiodol, 10cc per TACE. Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lipiodol | Lipiodol, 10cc per TACE. Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR | 18 HCC and 16 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u. | Posted | Count of Participants | Participants | 30 days, 90 days, and 180 days |
|
6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lipiodol/TACE | Lipiodol, 10cc per TACE. Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Adverse events assessed in relation to TACE procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Schlachter, MD | Yale University | (203) 785-5885 | todd.schlachter@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2015 | Feb 24, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2017 | Feb 24, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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|
| 30 days, 90 days, and 180 days |
| Baseline Enhancing Tumor and Response by mRECIST Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects. | 30 days, 90 days, 180 days |
| Tumor Response by World Health Organization (WHO) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria: Complete Response (CR): disappearance of all lesions for >= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions. Overall Response: CR + PR. | 6 months |
| Baseline Enhancing Tumor and Response by WHO Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects. | 30 days, 90 days, 180 days |
| Tumor Response by European Association for the Study of the Liver (EASL) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response: Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions. Overall Response: CR+PR | 6 months |
| Baseline Enhancing Tumor and Response by EASL Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects. | 30 days, 90 days, 180 days |
| Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria: Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment. Overall Response: CR + PR | 6 months |
| Baseline Enhancing Tumor and Response by qEASL Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects. | 30 days, 90 days, 180 days |
| 6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE | Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional. | 6 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Declining clinical status |
|
| Liver transplant |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor Type | Count of Participants | Participants |
|
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
| OG001 | Lipiodol (Non-HCC) | Lipiodol, 10cc per TACE. Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). |
|
|
| Primary | Baseline Enhancing Tumor and Response by RECIST Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects. | 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u. | Posted | Median | Full Range | % tumor enhancement | 30 days, 90 days, 180 days |
|
|
|
|
| Secondary | Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST): Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR | 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u. | Posted | Count of Participants | Participants | 30 days, 90 days, and 180 days |
|
|
|
| Secondary | Baseline Enhancing Tumor and Response by mRECIST Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects. | 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u. | Posted | Median | Full Range | % tumor enhancement | 30 days, 90 days, 180 days |
|
|
|
|
| Secondary | Tumor Response by World Health Organization (WHO) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria: Complete Response (CR): disappearance of all lesions for >= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions. Overall Response: CR + PR. | 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Baseline Enhancing Tumor and Response by WHO Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects. | 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u. | Posted | Median | Full Range | % tumor enhancement | 30 days, 90 days, 180 days |
|
|
|
|
| Secondary | Tumor Response by European Association for the Study of the Liver (EASL) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response: Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions. Overall Response: CR+PR | 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Baseline Enhancing Tumor and Response by EASL Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects. | 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u. | Posted | Median | Full Range | % tumor enhancement | 30 days, 90 days, 180 days |
|
|
|
|
| Secondary | Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria | Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria: Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment. Overall Response: CR + PR | 16 HCC and 14 non-HCC subjects had complete data for qEASL analysis at 30day f/u, 9 HCC and 7 non-HCC at 90 day f/u, and 9 HCC and 5 non-HCC at 180 day f/u. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Baseline Enhancing Tumor and Response by qEASL Criteria | Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects. | 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u. | Posted | Median | Full Range | % tumor enhancement | 30 days, 90 days, 180 days |
|
|
|
|
| Secondary | 6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE | Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional. | Kaplan-Meier survival analysis to estimate survival rate% at 6 months. Subjects are censored if survival is unknown at time point due to loss to followup. | Posted | Number | percentage of partcipants | 6 months |
|
|
|
| 2 |
| 39 |
| 11 |
| 39 |
| 33 |
| 39 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic abscess | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| Non-responders |
|
| Non-responders |
|
| (30 day) Nonresponders |
|
|
| (90 day) Responders |
|
|
| (90 day) Nonresponders |
|
|
| (180 day) Responders |
|
|
| (180 day) Nonresponders |
|
|
Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. |
| Wilcoxon (Mann-Whitney) |
| .09 |
Statistical significance defined as p <= 0.05. Data for 90 day timepoint. |
| Other |
| Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. | Wilcoxon (Mann-Whitney) | 0.034 | Statistical significance defined as p <= 0.05. Data for 180 day timepoint. | Other |
| Non-responders |
|
| 90 day f/u |
|
|
| 180 day f/u |
|
|
| (30 days) Nonresponders |
|
|
| (90 days) Responders |
|
|
| (90 days) Nonresponders |
|
|
| (180 days) Responders |
|
|
| (180 days) Nonresponders |
|
|
Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. |
| Wilcoxon (Mann-Whitney) |
| 0.011 |
Statistical significance defined as p <= 0.05. Data for 90 day timepoint. |
| Other |
| Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. | Wilcoxon (Mann-Whitney) | 0.94 | Statistical significance defined as p <= 0.05. Data for 180 day timepoint. | Other |
| Non-responders |
|
| 90 day f/u |
|
|
| 180 day f/u |
|
|
| (30 days) Nonresponders |
|
|
| (90 days) Responders |
|
|
| (90 days) Nonresponders |
|
|
| (180 days) Responders |
|
|
| (180 days) Nonresponders |
|
|
Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. |
| Wilcoxon (Mann-Whitney) |
| 0.017 |
Statistical significance defined as p <= 0.05. Data for 90 day timepoint. |
| Other |
| Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. | Wilcoxon (Mann-Whitney) | 0.08 | Statistical significance defined as p <= 0.05. Data for 90 day timepoint. | Other |
| Non-responders |
|
| 90 day f/u |
|
|
| 180 day f/u |
|
|
| (30 days) Nonresponders |
|
|
| (90 days) Responders |
|
|
| (90 days) Nonresponders |
|
|
| (180 days) Responders |
|
|
| (180 days) Nonresponders |
|
|
Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. |
| Wilcoxon (Mann-Whitney) |
| 0.029 |
Statistical significance defined as p <= 0.05. Data for 90 day timepoint. |
| Other |
| Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. | Wilcoxon (Mann-Whitney) | 0.94 | Statistical significance defined as p <= 0.05. Data for 180 day timepoint. | Other |
| Non-responders |
|
| 90 day f/u |
|
|
| 180 day f/u |
|
|
| (30 days) Nonresponders |
|
|
| (90 days) Responders |
|
|
| (90 days) Nonresponders |
|
|
| (180 days) Responders |
|
|
| (180 days) Nonresponders |
|
|
Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. |
| Wilcoxon (Mann-Whitney) |
| 0.013 |
Statistical significance defined as p <= 0.05. Data for 90 day timepoint. |
| Other |
| Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup. | Wilcoxon (Mann-Whitney) | 0.67 | Statistical significance defined as p <= 0.05. Data for 180 day timepoint. | Other |