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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04264806
Registration number
NCT04264806
Ethics application status
Date submitted
7/02/2020
Date registered
11/02/2020
Titles & IDs
Public title
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
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Scientific title
A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
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Secondary ID [1]
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2019-003576-40
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Secondary ID [2]
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CR108734
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes
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Leukemia, Myelomonocytic, Chronic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Cusatuzumab
Experimental: Azacitidine: Participants with MDS or CMML - Participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) will receive azacitidine 75 milligram per meter square (mg/m\^2) body surface area (BSA) subcutaneously or Intravenously per local label on Days 1 through Day 7 of each 28-day cycle. Participants will be treated until disease progression; relapse from complete remission (CR), partial remission (PR), or marrow complete remission (mCR); transformation to acute myeloid leukemia (AML); death; or unacceptable toxicity.
Experimental: Azacitidine and Cusatuzumab: Participants with MDS or CMML - Participants with higher-risk MDS or CMML will receive azacitidine 75 mg/m\^2 BSA subcutaneously or Intravenously per local label on Days 1 through 7 and cusatuzumab 20 mg/kg IV on Days 3 and 17 of each 28-day cycle. Participants will be treated until disease progression; relapse from CR, PR, mCR; transformation to AML; death; or unacceptable toxicity.
Treatment: Drugs: Azacitidine
Participants will receive subcutaneous (SC) or intravenous (IV) injection of Azacitidine 75 mg/m\^2.
Treatment: Drugs: Cusatuzumab
Participants will receive SC or IV injection of Cusatuzumab 20 mg/kg.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is a composite of complete remission (CR), partial remission (PR) and marrow complete remission (mCR) as per modified International Working Group (IWG) criteria.
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Timepoint [1]
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Up to 4 years
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Secondary outcome [1]
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Percentage of Participants Achieving Complete Remission (CR)
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Assessment method [1]
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Percentage of participants achieving CR as per IWG criteria will be reported.
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Timepoint [1]
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Up to 4 years
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Secondary outcome [2]
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Percentage of Participants who Achieve Transfusion Independence
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Assessment method [2]
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Percentage of participants who achieve transfusion independence will be reported. Transfusion independence is defined as a period of greater than or equal to (\>=) 56 consecutive days with no transfusion occurring between the first and last dose of study drug +30 days.
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Timepoint [2]
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Up to 4 years
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Secondary outcome [3]
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Time to Transformation of Participants to Acute Myeloid Leukemia (AML)
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Assessment method [3]
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Time to transformation of participants to AML will be reported. Transformation to AML is defined as \>= 20% bone marrow blasts.
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Timepoint [3]
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Up to 4 years
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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PFS is defined as the time from randomization to disease progression; relapse from CR, PR, or mCR; or death from any cause.
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Timepoint [4]
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Up to 4 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as the time from randomization to death.
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Timepoint [5]
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Up to 4 years
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Secondary outcome [6]
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Hematologic Improvement Rate
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Assessment method [6]
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Hematologic improvement rate is defined as erythroid response (pretreatment, less than (\<) 11 g/dL; hemoglobin \>= 1.5 g/dL; relevant reduction of units of RBC transfusions by an absolute number of \>= 4 Red blood cell (RBC) transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of \<= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation; platelet response (pretreatment \<100\*10\^9/L); absolute increase of \>= 30\*109/L for participants starting with \>20\*10\^9/L platelets; increase to \>20\*109/L and by \>= 100% for participants starting with \<= 20\*109/L platelets; Neutrophil response (pretreatment \<1.0×10\^9/L); and at least 100% increase and an absolute increase of \>0.5\*10\^9/L.
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Timepoint [6]
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Up to 4 years
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Secondary outcome [7]
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Percentage of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [7]
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Timepoint [7]
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Up to 4 years
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Secondary outcome [8]
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Percentage of Participants With Clinically Significant Abnormalities in Laboratory Parameters
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Assessment method [8]
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Percentage of participants with clinically significant abnormalities in laboratory parameters will be reported.
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Timepoint [8]
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Up to 4 years
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Secondary outcome [9]
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Area Under the Serum Concentration-Time Curve Within Timespan t1 to t2 (AUC[t1-t2]) of Cusatuzumab
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Assessment method [9]
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The AUC(t1-t2) is the area under the serum concentration-time curve within timespan t1 to t2.
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Timepoint [9]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [10]
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Maximum Serum Concentration (Cmax) of Cusatuzumab
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Assessment method [10]
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Cmax is the maximum observed serum concentration.
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Timepoint [10]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [11]
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Minimum Serum Concentration (Cmin) of Cusatuzumab
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Assessment method [11]
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Cmin is the minimum observed serum concentration.
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Timepoint [11]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [12]
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Elimination Half-Life (t1/2) of Cusatuzumab
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Assessment method [12]
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T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
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Timepoint [12]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [13]
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Systemic Clearance (CL) of Cusatuzumab
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Assessment method [13]
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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Timepoint [13]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [14]
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Volume of Distribution (Vz) of Cusatuzumab
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Assessment method [14]
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The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
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Timepoint [14]
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Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
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Secondary outcome [15]
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Number of Participants with Developed Antidrug Antibodies to Cusatuzumab
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Assessment method [15]
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Venous blood samples are analyzed for presence of antidrug antibodies to cusatuzumab. Participants with titer of confirmed positive samples for cusatuzumab antibodies are reported.
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Timepoint [15]
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Cycle 1: Day 3 (Predose); Cycle 1: Day 17 (Predose); Cycle 2: Day 3 (Predose); Cycle 8 and 11: Day 3 (Predose) and EOT (up to 4 years)
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Secondary outcome [16]
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Percentage of Participants Achieving Complete Remission (CR) and Partial Remission (PR)
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Assessment method [16]
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Percentage of participants achieving CR and PR as per IWG criteria will be reported.
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Timepoint [16]
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Up to 4 years
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Secondary outcome [17]
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Time to response
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Assessment method [17]
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Time to response for participants who achieved CR, PR and mCR responses, defined as time from randomization to achieving the first response of CR, PR, or mCR as per modified IWG criteria.
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Timepoint [17]
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Up to 4 years
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Secondary outcome [18]
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Duration of response
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Assessment method [18]
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Time from achieving the first response of CR, PR, or mCR to relapse or death from any cause for those participants who responded.
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Timepoint [18]
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Up to 4 years
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Secondary outcome [19]
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Percentage of Participants With Clinically Meaningful Improvement in Functional Assessment of Cancer Therapy - Anemia Trial Outcome Index (FACT-An TOI) Total Score
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Assessment method [19]
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FACT-An is a scale in Functional Assessment of Chronic Illness Therapy Measurement System. It consists of Functional Assessment of Cancer Therapy (general version; FACT-G) and 20 questions labeled "additional concerns" that measure anemia/fatigue. FACT-G is 27-item compilation of general questions divided into 4 primary quality of life domains: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. Participants will be asked to rate scale items as it applies to past 7 days, on 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). Negatively stated items will be reversed by subtracting the response from 4. After reversing the proper items, items are summed to a total to generate a score on (sub)scale. A summary Trial Outcome Index total score (FACT An TOI) will be calculated by summing physical well being, functional well being, and anemia symptoms subscales and higher is the score better is the quality of life.
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Timepoint [19]
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Up to 4 years
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Eligibility
Key inclusion criteria
* Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016 criteria
* At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per Revised International Prognostic Scoring System [IPSS R]) OR higher-risk CMML (intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System [CPSS-Mol]). Participants with previous lower-risk MDS or CMML that has evolved to higher-risk MDS or CMML are eligible
* At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than (<) 3 * upper limit of normal (ULN); Total bilirubin less than or equal to (<=) 1.5 * ULN, unless bilirubin rise is due to Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater than (>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) (by Modification of Diet in Renal Disease formula)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs), for higher-risk MDS or CMML. Prior supportive therapies including transfusion and growth factors are acceptable
* Received prior treatment with cusatuzumab
* Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl) rearrangement
* Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
* Any active systemic infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
6/05/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincents Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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Peter MacCallum Cancer Institute - Melbourne
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Recruitment hospital [4]
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Royal Perth Hospital - Perth
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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2500 - Wollongong
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Curitiba
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Country [2]
0
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Brazil
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State/province [2]
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Florianopolis
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0
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Brazil
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State/province [3]
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Natal
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Country [4]
0
0
Brazil
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State/province [4]
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Porto Alegre
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0
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Brazil
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State/province [5]
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Rio De Janeiro
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Country [6]
0
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Brazil
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State/province [6]
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São José do Rio Preto
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Country [7]
0
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Brazil
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State/province [7]
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São Paulo
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Country [8]
0
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France
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State/province [8]
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Angers
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Country [9]
0
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France
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State/province [9]
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Lille
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Country [10]
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France
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State/province [10]
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Limoges
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Country [11]
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France
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State/province [11]
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Marseille
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Country [12]
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France
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State/province [12]
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Nice
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Country [13]
0
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France
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State/province [13]
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Paris Cedex 10
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Country [14]
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France
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State/province [14]
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Paris, 75
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Country [15]
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France
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State/province [15]
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Tours
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Country [16]
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France
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State/province [16]
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Vandoeuvre Les Nancy
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0
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Germany
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State/province [17]
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Dresden
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Country [18]
0
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Germany
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Freiburg Im Breisgau
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0
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Germany
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Hannover
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0
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Germany
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Leipzig
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0
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Germany
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München
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0
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Germany
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Ulm
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Italy
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Bologna
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0
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Italy
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State/province [24]
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Cona
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0
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Italy
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Novara
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0
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Italy
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State/province [26]
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Orbassano
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Country [27]
0
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Italy
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State/province [27]
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Reggio Calabria
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0
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Italy
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State/province [28]
0
0
Roma
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Country [29]
0
0
Italy
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State/province [29]
0
0
Rozzano
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Country [30]
0
0
Russian Federation
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State/province [30]
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0
Dzerzhinsk
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Country [31]
0
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Russian Federation
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State/province [31]
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0
Moscow
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Country [32]
0
0
Russian Federation
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State/province [32]
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Nizhny Novgorod
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Country [33]
0
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Russian Federation
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State/province [33]
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Ryazan
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Country [34]
0
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Russian Federation
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State/province [34]
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Saint-Petersburg
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0
0
Russian Federation
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0
St-Petersburg
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0
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Russian Federation
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State/province [36]
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St. Petersburg
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Country [37]
0
0
Russian Federation
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Syktyvkar
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0
0
Saudi Arabia
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Dammam
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Saudi Arabia
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State/province [39]
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Jeddah
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0
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Saudi Arabia
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State/province [40]
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Riyadh
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0
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Spain
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State/province [41]
0
0
Badalona
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0
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Spain
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Barcelona
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0
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Spain
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0
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Madrid
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Country [44]
0
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Spain
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Palma
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Country [45]
0
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Spain
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State/province [45]
0
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Salamanca
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Country [46]
0
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Spain
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State/province [46]
0
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Sevilla
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0
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Switzerland
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State/province [47]
0
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Bern
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0
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Switzerland
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Geneve
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0
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Switzerland
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State/province [49]
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Zürich
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Country [50]
0
0
Turkey
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0
0
Ankara
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0
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Turkey
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0
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Istanbul
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Country [52]
0
0
Turkey
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State/province [52]
0
0
Izmir
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Country [53]
0
0
Turkey
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State/province [53]
0
0
Samsun
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Country [54]
0
0
United Kingdom
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State/province [54]
0
0
Leeds
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Country [55]
0
0
United Kingdom
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State/province [55]
0
0
London
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Country [56]
0
0
United Kingdom
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State/province [56]
0
0
Newcastle Upun Tyne
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Country [57]
0
0
United Kingdom
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State/province [57]
0
0
Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
argenx
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).
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Trial website
https://clinicaltrials.gov/study/NCT04264806
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical trials
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Janssen Research & Development, LLC
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04264806