Trial · NCT03405818
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Local Tolerability Reactions by Severity | Baseline up to Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study drug (up to Week 52) | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) By Severity | Baseline up to 28 days after last dose of study drug (up to Week 52) | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | percentage of leukocytes | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | percentage of leukocytes | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | volume percentage of red blood cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | volume percentage of red blood cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | 10^12 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | 10^12 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | 10^9 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | 10^9 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | International Unit per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | International Unit per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | milligram per deciliter (mg/dL) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Baseline, Week 52 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure. | milligram per deciliter (mg/dL) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline, Week 24 | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | millimole per liter (mmol/L) | 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
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GET https://conductscience.org/api/trials/v1/NCT03405818/outcomes