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The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of fruquintinib among adult participants who have been administered fruquintinib as per the approved indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Data will be collected for participants with metastatic colorectal cancer (mCRC) who will receive Fruzaqla according to the approved indication as per the Physician's routine schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | As this is an observational study, no intervention will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs | Up to approximately 6 years | |
| Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death | Up to approximately 6 years | |
| Number of Participants with AEs with Grade 3 or Higher | Up to approximately 6 years | |
| Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP) | Up to approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate | OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule. | Up to 6 months |
| Progression Free Survival (PFS) Rate |
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Inclusion Criteria:
Exclusion criteria:
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Participants with mCRC in South Korea who initiate the first treatment with Fruzaqla according to the approved indication will be included in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Hospital | Recruiting | Seoul | 03722 | South Korea |
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| Label | URL |
|---|---|
| To obtain more information on the study, click this link. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla capsule.
| Up to 6 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR). | Up to 18 treatment cycles (approximately up to 18 months) |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD). | Up to 18 treatment cycles (approximately up to 18 months) |
| Median Overall Survival (mOS) | OS will be defined as the time from the start date of Fruzaqla to the date of death from any cause. The mOS is the time at which 50% of participants are expected to have died from any cause. | Up to 18 treatment cycles (approximately up to 18 months) |
| Median Progression Free Survival (mPFS) | PFS will be defined as the time from the start date of Fruzaqla capsule to the date of documented progression or death from any cause. Tumor assessment will be performed by routine clinical practice of the investigators. The mPFS is the time at which 50% of participants are expected to have experienced disease progression or died from any cause. | Up to 18 treatment cycles (approximately up to 18 months) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |