Trial · NCT03896295
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 257 days post-baseline (Baseline is Day 1) | Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Up to 257 days post-baseline | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. |
| Primary | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Up to 257 days post-baseline | Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) were considered as AESIs. |
| Primary | Number of Participants With Treatment-emergent Abnormal Vital Signs | Up to 257 days post-baseline | Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to \[\<=\] 50 beats per minutes \[bpm\] with greater than or equal to \[\>=\] 15 bpm decrease from baseline, \>= 120 bpm with \>=15 bpm increase from baseline), systolic blood pressure (SBP) (\<= 90 millimeters of mercury \[mmHg\] with \>= 20 mmHg decrease from baseline, \>= 160 mmHg with \>= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (\<= 50 mmHg with \>=15 mmHg decrease from baseline, \>=100 mmHg with \>=15 mmHg decrease from baseline) were reported. |
| Primary | Number of Participants With Abnormalities in Physical Examinations | Week 12 | Number of participants with abnormalities in physical examinations (abdomen, head, ears, eyes, nose, throat, and sinuses, lungs, neurological, skin, blood and lymphatic system, cardiovascular, chest, gastrointestinal, general appearance and musculoskeletal) were reported. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein | Baseline up to Week 12 | Change from baseline in chemistry laboratory parameters: albumin and protein were reported. |
| 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 | Change from baseline in chemistry laboratory parameters: bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urate and urea nitrogen were reported. |
| 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 | Change from baseline in chemistry laboratory parameters alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline up to Week 12 | Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell) | Baseline up to Week 12 | Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline up to Week 12 | Change from baseline in hematology laboratory parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes were reported. |
| Primary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Baseline up to Week 12 | Change from baseline in erythrocytes mean corpuscular hemoglobin (HGB) concentration (hematology laboratory parameter) were reported. |
| Primary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) | Baseline up to Week 12 | Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Baseline up to Week 12 | Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameter: Hematocrit | Baseline up to Week 12 | Change from baseline in hematocrit (hematology laboratory parameter) was reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameter: Hemoglobin | Baseline up to Week 12 | Change from baseline in hemoglobin (hematology laboratory parameter) was reported. |
| Primary | Change From Baseline in Urinalysis Laboratory Parameter: pH | Baseline up to Week 12 | Change from baseline in pH (urinalysis laboratory parameter) was reported. |
| Primary | Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity | Baseline up to Week 12 | Change from baseline in specific gravity (urinalysis laboratory parameter) was reported. |
| Primary | Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values | Up to 257 days post-baseline | Number of participants with treatment-emergent abnormal ECG values for variables including mean heart rate (abnormally low refers to less than or equal to \[\<=\] 50 beats per minute \[bpm\], abnormally high refers greater than or equal to \[\>=\] 120 bpm), PR interval (abnormally low refers to \< 120 and abnormally high refers to \>200 milliseconds \[msec\]), RR interval (abnormally low refers to \<600 msec and abnormally high refers to \>1200 msec) and QRS duration (abnormally \> 120) were reported. |
| Primary | Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores | Up to 257 days post-baseline | Number of participants with C-SSRS scores were reported. C-SSRS is a clinician-administered questionnaire designed to solicit occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10, score of 0 was assigned (0="no event that can be assessed based on C-SSRS"). Higher total scores indicate greater severity. Maximum score assigned for each participant was summarized into one of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5): higher score indicates more suicidal ideation, suicidal behavior (6 to 10): higher score indicates more suicidal behavior. Suicidal ideation includes participants who did not have suicidal ideation or behavior at baseline and had suicidal ideation without behavior at some time point post-baseline. Suicidal behavior includes participants who did not have suicidal ideation or behavior at baseline and had suicidal behavior at some time point post-baseline (baseline=Day 1). |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03896295/registered