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Trial · NCT01007448

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity
Baseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical ConditionBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) InvolvementBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population).ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease SeverityBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity.daysMEAN
SECONDARYDuration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical ConditionBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition.daysMEAN
SECONDARYDuration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA InvolvementBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement.daysMEAN
SECONDARYTime to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease SeverityBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity.daysMEAN
SECONDARYTime to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical ConditionBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition.daysMEAN
SECONDARYTime to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA InvolvementBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement.daysMEAN
SECONDARYTime to Tumor Progression as Determined by CA of Index Lesion Disease SeverityBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with evaluable PD data for CA of index lesion disease severity.daysMEAN
SECONDARYTime to Tumor Progression as Determined by PGA of Clinical ConditionBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression.daysMEAN
SECONDARYTime to Tumor Progression as Determined by Percent BSA InvolvementBaseline up to Week 24Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression.daysMEAN

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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