Metastatic Colorectal CancerRegoFlex EUNCT05551039
An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe
An observational study of Metastatic Colorectal Cancer, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Retrospective patient chart review
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mCRC in France, Italy and Belgium and initiated regorafenib therapy between January 1, 2019 and December 31, 2021
Who may be able to join
- Patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages IVA, IVB, or IVC)
- Patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from January 1, 2019 to December 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest)
- Aged ≥18 years at index date
Who cannot join
- Patients with regorafenib treatment prior to January 1, 2019
- Patients who have participated in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients With Metastatic Colorectal Cancer in Europe
This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions.
Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted.
Read more
In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice.
In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium:
- at the beginning
- during, and
- at the end of the regorafenib therapy.
In addition, the study team will collect data about/if:
- the treatment duration at each treatment dose of regorafenib,
- the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium,
- reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment.
To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection.
Besides this data collection, no further tests or examinations are planned in this study.
There are no required visits or tests in this study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Retrospective patient chart review
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective patient chart reviewOther
Retrospective patient chart review to be completed by mCRC-treating physicians. Data is collected through an online case report form (CRF); physicians provide case histories of mCRC patients who initiated regorafenib treatment in most recent 3 years (2019-2021).
| Study group | Role | What they receive |
|---|---|---|
| Physicians treating patients with mCRC | Physicians provide case histories of mCRC patients Receives: Other: Retrospective patient chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Average dose intensity at first and subsequent cycles
The sum of dose strength (mg) will be divided by the days on therapy in each cycle.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to first dose change
Time to first dose change: time (months) from date of initial regorafenib dose to 1st dose increase/decrease among patients initiating a flexible regorafenib dose (40, 80, or 120 mg)
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to first full dose of 160 mg
Time to 1st full dose of 160 mg: time (months) from date of initial regorafenib dose to 1st full dose of 160 mg during the treatment history among patients with 40, 80, or 120 mg initial dose, overall and by initial dose.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Number of cycles received
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Proportion of patients initiating 1, 2, 3, or more cycles
The label recommended regorafenib treatment cycle is 28 days.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Duration of treatment (DoT)
Duration of treatment: time (months) from date of initial regorafenib dose to date of last dose prior to a >2-week gap during the follow up period.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to discontinuation (TTD)
Time to discontinuation: time (months) from date of initial regorafenib dose to date of discontinuation (as indicated by CRF)
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Proportion of patients with reasons for discontinuation
Reasons for discontinuation includes: distant progression/relapse, local progression/relapse, patient choice to discontinue therapy, poor performance status, side effects, new primary malignancy, death, lost to follow up, coronavirus disease 2019 (COVID-19)-related and other.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Secondary outcomes (11)
Descriptive summary of demographics characteristics
Demographic characteristics includes: age, sex, index year (calendar year of regorafenib treatment initiation date), race, alive or deceased at time of data collection, primary cause of death (for deceased patients only).
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Stage of disease
Stage of disease includes: Stage IVA; Stage IVB and Stage IVC
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status
ECOG scale scores are: 0, 1, 2, 3, 4 and Unknow. The higher score means worse performance status.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Primary tumor status
Primary tumor status includes: Local recurrence; Resected and Unresected
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Number of metastatic
Number of metastatic includes: 1, 2 and ≥3
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Site of metastasis
Site of metastasis includes: Bone, Liver, Lung, Lymph node, Peritoneum and Other.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of K-RAS mutation status and N-RAS mutation status
K-RAS mutation status and N-RAS mutation status includes: Wild type, Mutated and Unknown.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Line of therapy (LOT) for regorafenib
Line of therapy (LOT) for regorafenib includes: 2nd, 3rd, 4th and 5th or higher.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Prior adjuvant treatment
Prior adjuvant treatment includes: No and Yes.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Treatments prior to index date, overall and by LOT
Treatments includes: Fluorouracil, Capecitabine, Irinotecan, Leucovorin, Mitomycin, Oxaliplatin, Anti-EGFR monoclonal antibody snf Anti-VEGF monoclonal antibody.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Pre-existing comorbidities
Pre-existing comorbidities: Asthma, Atrial fibrillation, Auto-immune disease, Cardiac dysfunction, Chronic obstructive pulmonary disease, COVID-19, Diabetes, Hepatitis C, AIDS/HIV, Human papillomavirus, Liver dysfunction, Parkinson's, Peripheral neuropathy, Renal dysfunction, Thrombocytopenia, Venous thromboembolism, Other and None.
Measured: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Aug 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551039
- Sponsor's protocol ID
- 22124
- Acronym
- RegoFlex EU
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients With Metastatic Colorectal Cancer in Europe
- ClinicalTrials.gov ID
- NCT05551039
- Acronym / sponsor ID
- RegoFlex EU / 22124
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions.
Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted.
In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice.
In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium:
- at the beginning
- during, and
- at the end of the regorafenib therapy.
In addition, the study team will collect data about/if:
- the treatment duration at each treatment dose of regorafenib,
- the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium,
- reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment.
To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection.
Besides this data collection, no further tests or examinations are planned in this study.
There are no required visits or tests in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians treating patients with mCRC | – | Other: Retrospective patient chart reviewPhysicians provide case histories of mCRC patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mCRC in France, Italy and Belgium and initiated regorafenib therapy between January 1, 2019 and December 31, 2021
Key inclusion criteria (3 listed)
- Patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages IVA, IVB, or IVC)
- Patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from January 1, 2019 to December 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest)
- Aged ≥18 years at index date
Key exclusion criteria (2 listed)
- Patients with regorafenib treatment prior to January 1, 2019
- Patients who have participated in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective patient chart reviewRetrospective patient chart review to be completed by mCRC-treating physicians. Data is collected through an online case report form (CRF); physicians provide case histories of mCRC patients who initiated regorafenib treatment in most recent 3 years (2019-2021). | Other | Physicians treating patients with mCRC |
Primary outcome
Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Average dose intensity at first and subsequent cycles
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
The sum of dose strength (mg) will be divided by the days on therapy in each cycle.
Time to first dose change
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to first dose change: time (months) from date of initial regorafenib dose to 1st dose increase/decrease among patients initiating a flexible regorafenib dose (40, 80, or 120 mg)
Time to first full dose of 160 mg
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to 1st full dose of 160 mg: time (months) from date of initial regorafenib dose to 1st full dose of 160 mg during the treatment history among patients with 40, 80, or 120 mg initial dose, overall and by initial dose.
Number of cycles received
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Proportion of patients initiating 1, 2, 3, or more cycles
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
The label recommended regorafenib treatment cycle is 28 days.
Duration of treatment (DoT)
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Duration of treatment: time (months) from date of initial regorafenib dose to date of last dose prior to a >2-week gap during the follow up period.
Time to discontinuation (TTD)
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to discontinuation: time (months) from date of initial regorafenib dose to date of discontinuation (as indicated by CRF)
Proportion of patients with reasons for discontinuation
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Reasons for discontinuation includes: distant progression/relapse, local progression/relapse, patient choice to discontinue therapy, poor performance status, side effects, new primary malignancy, death, lost to follow up, coronavirus disease 2019 (COVID-19)-related and other.
11 secondary outcomes
Descriptive summary of demographics characteristics
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Stage of disease
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Primary tumor status
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Number of metastatic
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Site of metastasis
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of K-RAS mutation status and N-RAS mutation status
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Line of therapy (LOT) for regorafenib
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Prior adjuvant treatment
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Treatments prior to index date, overall and by LOT
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Descriptive summary of Pre-existing comorbidities
Time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg (time frame: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.