Trial · NCT00730639
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Serum Chemistry Laboratory Values | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test. | participants | NUMBER |
| SECONDARY | Immunogenicity Assessment | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed. | participants | NUMBER |
| SECONDARY | Objective Response Rate | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Tumor Response | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed. | months | MEDIAN |
| SECONDARY | Geometric Mean Maximum Serum Concentration (Cmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | micrograms per milliliter (µg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Abnormal Hematology Laboratory Values | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test. | participants | NUMBER |
| SECONDARY | Median Time of Maximum Serum Concentration (Tmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | hours (h) | MEDIAN |
| SECONDARY | Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | micrograms*hours per milliliter (μg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Total Body Clearance of Drug From Serum (CLT) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | milliliters per hour (mL/h) | GEOMETRIC_MEAN |
| SECONDARY | Mean Effective Half-life (T-HALFeff) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | hours (h) | 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00730639/outcomes