Trial · NCT04313608
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 30
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Deaths Due to Adverse Events (AEs) | Arm A: Glofit-GemOx | 1 | Participants | ||
| Number of Deaths Due to Adverse Events (AEs) | Arm B: Mosun-GemOx | 0 | Participants | ||
| Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs | Arm A: Glofit-GemOx | AEs leading to treatment discontinuation | 5.9 | percentage of participants | |
| Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs | Arm B: Mosun-GemOx | AEs leading to treatment discontinuation | 16.7 | percentage of participants | |
| Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs | Arm A: Glofit-GemOx | AEs leading to dose modification or interruption | 29.4 | percentage of participants | |
| Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs | Arm B: Mosun-GemOx | AEs leading to dose modification or interruption | 50.0 | percentage of participants | |
| Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria | Arm A: Glofit-GemOx | 23.5 | 95% Confidence Interval 6.81 to 49.90 | percentage | |
| Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria | Arm B: Mosun-GemOx | 50.0 | 95% Confidence Interval 11.81 to 88.19 | percentage | |
Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria | Arm A: Glofit-GemOx | 35.3 | Proportion expressed as percentage | ||
Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria | Arm B: Mosun-GemOx | 50.0 | Proportion expressed as percentage | ||
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | Pre-infusion Cycle 1 Day 8 | 0 | Full Range 0 to 0 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | Within 30 mins post infusion Cycle 1 Day 8 | 0.6 | Full Range 0.3 to 1.7 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 12 hours post infusion Cycle 1 Day 8 | 0.6 | Full Range 0.1 to 0.9 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 24 hours post infusion Cycle 1 Day 8 | 0.5 | Full Range 0.1 to 0.8 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 48 hours post infusion Cycle 1 Day 8 | 0.3 | Full Range 0 to 0.4 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | Pre-infusion Cycle 2 Day 1 | 0.8 | Full Range 0.1 to 1.3 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | Within 30 minutes post infusion Cycle 2 Day 1 | 9 | Full Range 6.8 to 17.7 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 6 hours post infusion Cycle 2 Day 1 | 7.8 | Full Range 5.5 to 13.1 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 20 hours post infusion Cycle 2 Day 1 | 6.5 | Full Range 4.4 to 11.2 | ug/mL |
| Maximum Serum Concentration (Cmax) of Glofitamab | Arm A: Glofit-GemOx | 44 hours post infusion Cycle 2 Day 1 | 3.8 | Full Range 3.2 to 4.3 | ug/mL |
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.
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GET https://conductscience.org/api/trials/v1/NCT04313608/results