Trial · NCT03222492
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population. | Proportion of participants | NUMBER |
| 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) | The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks. | proportion of participants | NUMBER |
| 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 | The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population. | proportion of participants | NUMBER |
| 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. | The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks | proportion of participants | NUMBER |
| 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. | The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks. | proportion of participants | NUMBER |
| 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 | The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population. | proportion of participants | NUMBER |
| 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 | The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks. | proportion of participants | NUMBER |
| 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 | The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population. | proportion of participants | NUMBER |
| 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. | The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks. | proportion of participants | NUMBER |
| 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. | 5 The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks. | proportion of participants | NUMBER |
| 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 | The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population. | proportion of participants | NUMBER |
| 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. | The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks. | proportion of participants | NUMBER |
| 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. | The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks. | proportion of participants | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03222492/outcomes