Trial · NCT03896295
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 257 days post-baseline (Baseline is Day 1) | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Abnormal Vital Signs | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Physical Examinations | Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). As per planned analysis, data is reported for individual arms and for all (total) participants both. | grams per liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | units per liter (U/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | micromoles per liter (micromol/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell) | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | 10^12 cells count per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | 10^9 cells count per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | grams per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | picograms (pg) | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | femtoliters (fL) | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameter: Hematocrit | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | liter of cells per liter of blood (L/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameter: Hemoglobin | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | g/L | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Laboratory Parameter: pH | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | pH | MEAN |
| PRIMARY | Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | ratio | MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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