Trial · NCT03405818
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Local Tolerability Reactions by Severity | Baseline up to Week 52 | Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production). |
| 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) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. |
| 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) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort. |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline, Week 24 | |
| Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Baseline, Week 52 | |
| Primary | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline, Week 24 |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03405818/registered