Trial · NCT03222492
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48. | Baseline through end of study (48 weeks for participants who complete the study) | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Primary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48. | Baseline through end of study (48 weeks) | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36. | Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12 | Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24. | Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36. | Baseline through Week 36 study visit or 36 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48. | Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12 | Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24. | Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36. | Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48. | Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin. |
| Secondary | Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48. | Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12 | Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24. | Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36. | Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48. | Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48. | Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12 | Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24. | Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
| Secondary | Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36. | Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed. | Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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