Trial · NCT00958477
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Dose Limiting Toxicity (DLT) | Baseline up to 6 weeks | DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity). | subjects | NUMBER |
| PRIMARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | Baseline up to 534 days | Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure. | Subjects | NUMBER |
| PRIMARY | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | h*mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Total Body Clearance of Drug From Serum (CL) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | L/h | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | Liters | GEOMETRIC_MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1 | pre-dose at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3 | pre-dose at Week 3 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5 | pre-dose at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| SECONDARY | Time to Reach Observed Serum Concentration (Tmax) After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | hours | MEDIAN |
| SECONDARY | Time to Reach Observed Serum Concentration (Tmax) After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | hours | MEDIAN |
| SECONDARY | Number of Subjects With Positive Anti-EMD 525797 Antibodies | Week 1, 3, 5, 8, 9 | Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure. | Subjects | NUMBER |
| SECONDARY | Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8) | Week 1 up to a maximum of 56 days | As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome. | ||
| SECONDARY | C-Reactive Protein Levels | Week 1 up to a maximum of 56 days | As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome. | ||
| SECONDARY | Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | hours | MEDIAN |
| SECONDARY | Elimination Rate Constant (λz) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | 1/h | GEOMETRIC_MEAN |
| SECONDARY | Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | MEAN |
| SECONDARY | Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion | pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1 | PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively. | h*mcg/mL | GEOMETRIC_MEAN |
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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