Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

March 27, 2025 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A Multicenter, NI, Retrospective, Observational Study Evaluating Real-World Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma (mRCC) Treated With Avelumab Plus Axitinib as First-line Therapy: J-DART2

This study is a multicenter, non-interventional, retrospective, medical chart review of participants with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Hirosaki University Hospital
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Kobe University Hospital
      • Kobe-city, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
    • Kōchi
      • Nankoku, Kōchi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Suita-city, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Saitama
      • Saitama City, Saitama, Japan, 330-8503
        • Jichi Medical University Saitama Medical Center
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
    • Yamagata
      • Yamagata-Shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022

Description

Inclusion Criteria:

  1. Diagnoses of mRCC based on the General Rule for Clinical and Pathological Studies on RCC (Fifth Edition) before receiving avelumab plus axitinib as first-line therapy. Patients with mRCC who have unresectable disease, either unresectable locally advanced or metastatic disease.
  2. Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
  3. Index date from 20 December 2019 to 17 October 2022.

Exclusion Criteria:

  1. Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period.
  2. Patients (or a patient's legally representative) refusing to provide patient data during the consent process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with metastatic renal cell carcinoma
Drug: avelumab
as provided in real world practice
Drug: axitinib
as provided in real world practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Age of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The age of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Height of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The height of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Body Weight of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The body weight of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Body Mass Index of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The body mass index (BMI) of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
C-Reactive Protein Levels of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The C-reactive protein levels of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Estimated Glomerular Filtration Rate of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The estimated Glomerular Filtration Rate (eGFR) is an index of kidney function. eGFR was calculated using factors such as serum creatinine level, age, sex, and in millimeter per minute per 1.73 square meter (ml/min/1.73 m^2), and tabulated in three categories (<60, ≥60, unknown). An eGFR <60 indicates some degree of kidney impairment. And eGFR > 60 is generally considered to be within the normal range.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Smoking History Status of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The smoking history status of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Eastern Cooperative Oncology Group (ECOG) Performance Scale Score Status of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Metastatic Organs at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The Number of participants with Metastatic Organs of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Invasion Depth (T Factor) of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
TX: Primary tumor cannot be assessed, T0: No evidence of primary tumor, T1: Tumor ≤7 cm in greatest dimension, limited to the kidney, T1a: Tumor≤4cm in greatest dimension, limited to the kidney, T1b: Tumor>4 cm but ≤7 cm in greatest dimension, limited to the kidney, T2: Tumor >7 cm in greatest dimension, limited to the kidney, T2a: Tumor >7 cm but ≤10 cm in greatest dimension, limited to the kidney, T2b: Tumor >10 cm, limited to the kidney, T3: Tumor extends into major veins or perinephric tissues, but not into the ipsilateral adrenal gland and not beyond Gerota's fascia,T3a: Tumor extends into the renal vein or its segmental branches, or invades the pelvicalyceal system, or invades perirenal and, T3b: Tumor extends into the vena cava below the diaphragm, T3c: Tumor extends into the vena cava above the diaphragm or invades the wall of the vena cava, T4: Tumor invades beyond Gerota's fascia (including contiguous extension into the ipsilateral adrenal gland)
At Baseline (prior to initial treatment with avelumab plus axitinib)
Lymph Node Metastasis (N Factor) Status of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Lymph node metastasis (N factor) of participants at baseline was reported. NX: Regional lymph nodes cannot be assessed, N0: No regional lymph node metastasis, N1: Metastasis in regional lymph node(s).
At Baseline (prior to initial treatment with avelumab plus axitinib)
Distant Metastasis (M Factor) Status of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Distant metastasis (M factor) of participants at baseline was reported. M0: No distant metastasis, M1: Distant metastasis.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Tumor Histological Type of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Tumor histological type of participants at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Presence or Absence of Sarcomatoid Component in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants with Presence or Absence of Sarcomatoid Component at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Fuhrman Grade Status of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against "Unknown'.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Availability of Proteinuria in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative (-)= <15 milligrams per deciliter (mg/dL) (Normal), positive (±) =15-29 mg/dL (increased risk for kidney disease), (1+) = 30 mg/dL(Early stages of kidney disease), (2+)= 100 mg/dL (Underlying kidney disease), (3+)= 300 mg/dL (kidney dysfunction).
At Baseline (prior to initial treatment with avelumab plus axitinib)
Performance of Nephrectomy in Participants
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Performance of nephrectomy at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Presence or Absence of Clinically Important Comorbidities of Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants with Presence or absence of clinically important comorbidities at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Presence or Absence of Clinically Important Concomitant Drugs in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of participants with Presence or absence of clinically important concomitant drugs at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Initiation of Systemic Therapy Within One Year of Diagnosis
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants with Initiation of Systemic Therapy within One Year of Diagnosis was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Karnofsky Performance Status Less Than (<) 80 Percent (%) at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Hemoglobin Value Below the Lower Normal Limit at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of participants with Hemoglobin value below the lower normal limit at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Corrected Calcium Value Above the Upper Normal Limit in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of participants with Corrected calcium value above the upper normal limit at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants With Neutrophil Count Above the Upper Normal Limit in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Participants with Neutrophil count above the upper normal limit at baseline was reported.
At Baseline (prior to initial treatment with avelumab plus axitinib)
International Metastatic RCC Database Consortium (IMDC) Risk Group in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (<) 80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <1 year; corrected serum calcium; neutrophils and platelets more than (>) upper limit of normal (ULN); hemoglobin <lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: Low risk (0 factor), Medium risk (1-2 factors), High risk (more than or equal to [>=]3 factors).
At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of Risk Factors in Participants at Baseline
Time Frame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Number of risk factors in participants at baseline was reported
At Baseline (prior to initial treatment with avelumab plus axitinib)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Real-World Progression-Free Survival (Rw-PFS)
Time Frame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
rwPFS is defined as: The time from start of avelumab plus axitinib therapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever occurred first.
From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
Time to Treatment Discontinuation (TTD)
Time Frame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
TTD is defined as the time from the start of treatment with avelumab plus axitinib to the end of treatment due to any cause except the effectiveness of the treatment.
From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
Overall Survival (OS)
Time Frame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
OS is defined as the time from the start of treatment with avelumab plus axitinib to the date of death due to any cause. If there are no clinical records of death, the date when the patient was last documented to be alive will be confirmed based on medical records. The data will be censored at the date of last contact.
From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
Percentage of Participants With Best Overall Response of CR or PR (Objective Response Rate)
Time Frame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
The ORR is defined as the proportion of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable [NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
Number of Participants With Best Overall Response (BOR) for Primary Lesions
Time Frame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
BOR is the best tumor response recorded during observation period.Tumor response are defined as follows:Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD],not Evaluable[NE]) in a method complied with RECIST version. 1.1tumor assessment as closely as possible in clinical practice by investigator's judgment.CR:Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR:Atleast 30% decrease in sum of diameters of target lesions,taking as reference the baseline sum diameters.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters. PD:atleast a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B9991052
  • J-DART2 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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