Trial · NCT07881705
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The duration of severe neutropenia (DSN) in cycle 1 | During the first cycle (each cycle is 21 days) | The time duration of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC \< 0.5 × 10⁹/L). |
| Primary | The incidence of severe neutropenia (SN) | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | The incidence of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC \< 0.5 × 10⁹/L). |
| Secondary | Granulocyte colony-stimulating factor (G-CSF) utilization rate | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Incidence of febrile neutropenia | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | The lowest absolute neutrophil count in each cycle | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months] | |
| Secondary | Incidence of grade ≥3 hemoglobin decrease | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 month | |
| Secondary | Incidence of red blood cell transfusions (from Week 5 onward) | From Week 5 until 30 days after the end of study treatment, up to about 3 months | |
| Secondary | Erythropoiesis-stimulating agent (ESA) utilization rate | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Incidence of grade ≥3 platelet count decrease | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Incidence of platelet transfusions | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months. | |
| Secondary | Rate of thrombopoiesis-stimulating agent use. | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Incidence of grade 3 and 4 hematologic toxicities | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Changes over time in absolute neutrophil count, platelet count, absolute lymphocyte count, and hemoglobin | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | |
| Secondary | Composite endpoint: Incidence of important hematologic adverse events. | From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months | The proportion of patients who experience any of the following: hematologic adverse event that leads to hospitalization or prolongation of hospitalization, dose adjustment of chemotherapy, febrile neutropenia, prolongation of severe neutropenia(SN) (more than 5 days),or red blood cell (RBC) transfusions administered at or after Week 5. |
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.
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GET https://conductscience.org/api/trials/v1/NCT07881705/registered