Trial · NCT04113018
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Response or Stringent Complete Response to Induction | From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks | The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Objective Response (OR) | From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity; assessed for approximately 5 years | |||
| SECONDARY | Overall Survival (OS) | From date of treatment start to date of death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Progression Free Survival (PFS) | From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Time to Disease Progression (TTP) | From date of start of treatment to date of disease progression or death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Duration of Response (DoR) | From date of first response to date of progression or death, or censored as described; assessed for approximately 5 years | |||
| SECONDARY | Time to Next Treatment (TTNT) | From treatment start date to date of next treatment, or censored as described; assessed for approximately 5 years | |||
| OTHER_PRE_SPECIFIED | Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction | From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles). | The evaluable population is defined as all subjects who initiate treatment with daratumumab. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Grade 5 Adverse Events During Induction | From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles). | The evaluable population is defined as all subjects who initiate treatment with daratumumab. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Serious Adverse Event | From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years. | |||
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Treatment Emergent Adverse Event | From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years. | |||
| OTHER_PRE_SPECIFIED | Number of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event | From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years. | |||
| OTHER_PRE_SPECIFIED | Number of Participants Who Discontinued Study Treatment Due to Adverse Events | From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years. | |||
| OTHER_PRE_SPECIFIED | Daratumumab Administration - Number of Cycles Received | From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles). | The evaluable population is defined as all subjects who initiate treatment with daratumumab | count of cycles | MEDIAN |
| OTHER_PRE_SPECIFIED | Daratumumab Administration - Number of Doses Received | From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles). | The evaluable population is defined as all subjects who initiate treatment with daratumumab | count of doses | MEDIAN |
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/NCT04113018/outcomes