Trial · NCT04188509
Open-Label Extension of Voxelotor
NCT04188509, Phase 3, Terminated, Pfizer; results first posted 2025-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension of Voxelotor. Trials, record NCT04188509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04188509
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension of Voxelotor
- NCT number
- NCT04188509
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 162 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor
- First posted
- 2019-12-06
- Last updated
- 2025-11-13
- Other registries' IDs
- eudract:2019-003144-76
- Results first posted
- 2025-11-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. AEs included both serious AEs (SAEs) and all non-SAEs. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. |
| Primary | Number of Participants With SAEs | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. |
| Primary | Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | SCD-related AEs were common complications associated with the study participant's SCD and were not considered to be related to voxelotor unless judged by the investigator to have worsened in severity and/or frequency or changed in nature during the study. SCD-related complications included the following: sickle cell anemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (AEs) | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | The safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With SAEs | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | The safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) | The safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Voxelotor | 105 | Participants | ||
| Number of Participants With SAEs | Voxelotor | 53 | Participants | ||
| Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | Voxelotor | SCD related treatment emergent AE | 60 | Participants | |
| Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs | Voxelotor | SCD related SAEs | 43 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voxelotor | 162 | |
| Overall Study | COMPLETED | Voxelotor | 25 | |
| Overall Study | NOT COMPLETED | Voxelotor | 137 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Voxelotor | 27 | 162 | 53 |
| other | Anaemia | Blood and lymphatic system disorders | Voxelotor | 9 | 162 | 12 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Voxelotor | 6 | 162 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Voxelotor | 3 | 162 | 3 |
| other | Splenic sequestration crisis | Blood and lymphatic system disorders | Voxelotor | 2 | 162 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Voxelotor | 2 | 162 | 2 |
| other | Cytopenia | Blood and lymphatic system disorders | Voxelotor | 1 | 162 | 1 |
| other | Hypersplenism | Blood and lymphatic system disorders | Voxelotor | 1 | 162 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Voxelotor | 1 | 162 | 1 |
| other | Macrocytosis | Blood and lymphatic system disorders | Voxelotor | 1 | 162 | 1 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voxelotor | 1 | 162 |
| Total, other adverse events | Voxelotor | 93 | 162 |
| Total, serious adverse events | Voxelotor | 53 | 162 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04188509
GET https://conductscience.org/api/trials/v1/NCT04188509/events?page=2