Trial · NCT04101331
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | percentage | NUMBER |
| SECONDARY | Overall Response Rate Assessed by Investigator Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | percentage | NUMBER |
| SECONDARY | Overall Response Rate Assessed by Investigator Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | percentage | NUMBER |
| SECONDARY | Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | percentage | NUMBER |
| SECONDARY | Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | percentage | NUMBER |
| SECONDARY | Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC. | months | MEDIAN |
| SECONDARY | Duration of Overall Response Assessed by Independent Review Committee Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | All subjects of the full analysis set (FAS) who had a response in CT assessed by IRC. | months | MEDIAN |
| SECONDARY | Duration of Overall Response Assessed by Investigator Based on PET-CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | All subjects of the full analysis set (FAS) who had a response in PET-CT assessed by investigator. | months | MEDIAN |
| SECONDARY | Duration of Overall Response Assessed by Investigator Based on CT | Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months). | All subjects of the full analysis set (FAS) who had a response in CT assessed by investigator. | months | MEDIAN |
| SECONDARY | Number of Subjects With Treatment Related Adverse Event | From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks. | The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Measured Concentration (Cmax) of AFM13 | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Nanogram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞) | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | nanogram*hour/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) of AFM13 | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | Liter | GEOMETRIC_MEAN |
| SECONDARY | The Terminal Half-life (t1/2) of AFM13 | Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29. | The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement. | hour | GEOMETRIC_MEAN |
| SECONDARY | European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D) | At baseline and final study visit, up to 199 weeks. | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D) | From baseline until final study visit, up to 199 weeks. | The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13. | score on a scale | MEAN |
| SECONDARY | Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment | Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months. | The safety set consisted of all subjects who received at least one dose of AFM13and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
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
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GET https://conductscience.org/api/trials/v1/NCT04101331/outcomes