Trial · NCT04000165
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number Participants With Most Common Reported Drug Related Adverse Events | 14 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number Participants With Serious Adverse Events That Were Possibly Drug-related Serious Adverse Events | 14 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number Participants With Increase of ≥ 1 g/dL in Hemoglobin | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. Intention to treat analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hemoglobin at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | g/dL | MEAN |
| SECONDARY | Change in Lactic Acid Dehydrogenase (LDH) at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | U/L | MEAN |
| SECONDARY | Change in Total Bilirubin at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | mg/dL | MEAN |
| SECONDARY | Change in Absolute Reticulocyte Count at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | K/mcL | MEAN |
| SECONDARY | Change in Aspartate Aminotransferase (AST) at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | U/L | MEAN |
| SECONDARY | Change in Mean Corpuscular Volume (MCV) at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | fL | MEAN |
| SECONDARY | Change in Fetal Hemoglobin at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | Percent HbF | MEAN |
| SECONDARY | Percent Change From Baseline of 2,3-DPG at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline of Adenosine Triphosphate (ATP) at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Oxygen Binding p50 Value at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | Percent Change | MEAN |
| SECONDARY | Percent Change in Time (Mins) at Which 50% of Red Blood Cells Are Sickled (t50) Value at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | percent change | MEAN |
| SECONDARY | Percent Change of PK-R at Each Dose Level of AG-348 | 14 weeks | One participant, withdrawn 3 days after starting the study for a pre-existing pulmonary embolus, was not evaluable for response. 10 participants escalated to 100 mg dose with 1 participant self-discontinued 3 days after escalating to 100 mg dose. Intention to treat analysis. | percent change | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04000165/outcomes