Calculate details of a primary endpoint of a study
Source:R/f_primaryEndpointDescription.R
f.primaryEndpointDescription.RdTrial concept calculated: full description of the primary endpoint, concatenating with " == " its title, description, time frame of assessment. The details vary by register. The text description can be used for identifying trials of interest or for analysing trends in primary endpoints, which among the set of all endpoints are most often used for determining the number of participants sought for the study.
Arguments
- df
data frame such as from dbGetFieldsIntoDf. If `NULL`, prints fields needed in `df` for calculating this trial concept, which can be used with dbGetFieldsIntoDf.
Value
data frame with columns `_id` and `.primaryEndpointDescription`, which is a list (that is, one or more items in one vector per row; the background is that some trials have several endpoints as primary).
Examples
# fields needed
f.primaryEndpointDescription()
#> $euctr
#> [1] "e51_primary_end_points"
#> [2] "e511_timepoints_of_evaluation_of_this_end_point"
#>
#> $ctgov
#> [1] "primary_outcome.measure" "primary_outcome.description"
#> [3] "primary_outcome.time_frame"
#>
#> $ctgov2
#> [1] "protocolSection.outcomesModule.primaryOutcomes.measure"
#> [2] "protocolSection.outcomesModule.primaryOutcomes.description"
#> [3] "protocolSection.outcomesModule.primaryOutcomes.timeFrame"
#>
#> $isrctn
#> [1] "trialDescription.primaryOutcome"
#>
#> $ctis
#> [1] "authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.primaryEndPoints.endPoint"
#> [2] "authorizedPartI.trialDetails.trialInformation.endPoint.primaryEndPoints.endPoint"
#>
# apply trial concept when creating data frame
dbc <- nodbi::src_sqlite(
dbname = system.file("extdata", "demo.sqlite", package = "ctrdata"),
collection = "my_trials", flags = RSQLite::SQLITE_RO
)
trialsDf <- dbGetFieldsIntoDf(
calculate = "f.primaryEndpointDescription",
con = dbc
)
#> Querying database (11 fields)...
trialsDf
#> _id
#> 1 12949496
#> 2 13281214
#> 3 17473621
#> 4 2012-003632-23-CZ
#> 5 2012-003632-23-SE
#> 6 2014-002606-20-PT
#> 7 2014-003556-31-GB
#> 8 2014-003556-31-SE
#> 9 2022-500244-37-00
#> 10 2022-501142-30-00
#> 11 2023-505613-24-00
#> 12 2023-508143-51-01
#> 13 2024-510663-34-00
#> 14 20343063
#> 15 61070850
#> 16 76463425
#> 17 80181452
#> 18 88261002
#> 19 NCT00617929
#> 20 NCT01125800
#> 21 NCT01483820
#> 22 NCT01505608
#> 23 NCT01592045
#> 24 NCT02620761
#> 25 NCT03280147
#> 26 NCT03325439
#> 27 NCT03431558
#> 28 NCT03876704
#> 29 NCT04001712
#> 30 NCT04041765
#> 31 NCT05969327
#> .primaryEndpointDescription
#> 1 Time on iNO therapy and the time spent on invasive ventilation
#> 2 Chronic lung disease, defined as the need for oxygen at 36 weeks corrected age, and/or death before discharge. This will be assessed prior to hospital discharge at 36 weeks corrected age.
#> 3 Bilirubin serum level measured by examination of blood serum at 24 hours after the start of phototherapy
#> 4 Safety parameters to be collected and assessed: - Incidence, severity, causality and outcomes of Adverse Events serious and non-serious, with particular attention being paid to infections - Evolution of laboratory parameters such as complete blood cell count CBC, with a focus on red cells haemoglobin, neutrophils and platelets, liver tests, renal function tests and coagulation - Number of patients withdrawn for safety issues Evolution of clinical signs fever, splenomegaly, CNS symptoms and laboratory parameters CBC, fibrinogen, serum triglycerides, ferritin, soluble CD-25 levels, which characterize the disease, will be used to assess response and time to response. As this is a pilot study, all endpoints will be considered exploratory. - Number of patients showing partial or complete response by week 2, 4 or 8 - Number of patients achieving non-active disease by week 8 - Time to achievement of non-active disease state - Time to achievement of complete response - Time to achievement of partial response - Time to reactivation - Survival at week 8 and at the end of the follow-up period week 12 - Number of patients achieving no response at any time - Number of patients showing reactivation at any time. == See E.5.1.
#> 5 Primary efficacy endpoint: - Overall response Rate, i.e. achievment of either Complete or Partial response of HLH Improvement at End of Trial EoT == See E.5.1.
#> 6 Primary Safety: The composite of major and clinically relevant non-major bleeding. Primary Efficacy: A composite of: i all image-confirmed and adjudicated symptomatic and asymptomatic recurrent VTE defined as either contiguous progression or non-contiguous new thrombus and including DVT, PE and paradoxical embolism and ii VTE-related mortality. == Listed with Endpoints
#> 7 The primary efficacy endpoints of this study are: - Visual acuity as assessed by an age appropriate method - Ocular alignment and ocular motor examination in primary gaze and in as many of 9 positions of gaze as possible as assessed by corneal light reflex and by the cover test - Assessment of nystagmus by observation - Refraction as assessed by retinoscopy with cycloplegia - Stereoacuity as assessed with the Lang Stereotest == will vary depending upon age at enrollment, but subjects will not be followed beyond age 5.5 years corrected age CA
#> 8 The primary efficacy endpoints of this study are: - Visual acuity as assessed by an age appropriate method - Ocular alignment and ocular motor examination in primary gaze and in as many of 9 positions of gaze as possible as assessed by corneal light reflex and by the cover test - Assessment of nystagmus by observation - Refraction as assessed by retinoscopy with cycloplegia - Stereoacuity as assessed with the Lang Stereotest == will vary depending upon age at enrollment, but subjects will not be followed beyond age 5.5 years corrected age CA
#> 9 Number of days alive with no score > 1 in each of the symptoms and a maximum of 3 points in the total score, measured from inclusion to day 28
#> 10 Proportion of patients vaginally delivered <24h (binary endpoint Yes/No), Satisfaction of women concerning method of induction assessed between the second day after delivery (D2) and hospital discharge by the EXperience of Induction Tool (EXIT) validated in french language
#> 11 Average concentration (Cavg) of single-dose IV POS (Panel A), Maximum concentration (Cmax) of single-dose IV POS (Panel A), Time to maximum concentration (Tmax) of single-dose IV POS (Panel A), Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A), Clearance (CL) of single-dose IV POS (Panel A), Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A), Cavg of multiple-dose IV POS (Panel B), Cmax of multiple-dose IV POS (Panel B), Tmax of multiple-dose IV POS (Panel B), AUC0-24 of multiple-dose IV POS (Panel B), CL of multiple-dose IV POS (Panel B), Cavg of multiple-dose PFS (Panel B), Cmax of multiple-dose PFS (Panel B), AUC0-24 of multiple-dose PFS (Panel B)
#> 12 The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function
#> 13 Area under the serum concentration-time curve (AUC), Maximum serum concentration (Cmax), Clearance (CL), Terminal half-life (t1/2)
#> 14 1. Enterocolitis2. The follow-up of each patient is 1 month3. The total test duration is 3 years
#> 15 1. Number of days required to reach 1800 g in weight2. Type of treatment administered3. Weight4. Height5. Cephalic perimeter6. Mid-arm circumferenceMeasured at 21 days.
#> 16 Moderate or severe disability at 24 months post menstrual age
#> 17 Combination of BPD or death at 36 weeks gestational age
#> 18 The incidence of microbiologically-confirmed or clinically suspected late-onset infection from trial entry until hospital discharge. Clinicians will record whether or not infants have been treated for late-onset infection on the data collection form, however we are not recording specific test results.
#> 19 Rate of Sustained Donor Engraftment == Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection. == Day 42 post transplantation, Survival at 100 Days Post Transplant == Percent of patients alive from beginning of study to Day 100 post transplantation == Day 100 post transplantation
#> 20 Number of Participants With Dose-limiting Toxicities (DLT) in Phase I == DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC \\<1.0x10\\^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets \\<50x10\\^9/L); ≥ CTCAE grade 3 anemia (Hgb \\<80 g/L); Febrile neutropenia (ANC \\<1x10\\^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (\\>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (\\>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (\\>1.5ULN) together with ≥ grade 3 ALT elevation (\\>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment. == Baseline, End of dose escalation part (Day 42), Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use == MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k == Baseline, End of dose escalation part (Day 42), Percentage of Participants With Objective Response Rate (ORR) by Treatment == The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively. == Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)
#> 21 Number of Participants With Adverse Events as a Measure of Safety and Tolerability == Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year. == length of study +30 days
#> 22 Number of Participants With Adverse Events as a Measure of Safety and Tolerability == To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma.\n\nPhase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287. == 6 months, Overall Response Rate (ORR) of Participants Using RECIST Criteria == Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns).\n\nPhase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. == 3 years
#> 23 Area Under the Plasma Concentration Curve (AUC) == Twenty-two PK samples will be obtained at the following timepoints:\n\nCourses 1 and 3:\n\nDay: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample\n\nCourses 2 and 4:\n\nDay 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin == PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment, Peak Plasma Concentration (Cmax) == Twenty-two PK samples will be obtained at the following timepoints:\n\nCourses 1 and 3:\n\nDay: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample\n\nCourses 2 and 4:\n\nDay 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin == PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment
#> 24 Changes in Urine Output (ml/kg/hr) == Urine will be collected and measured in 6 hour increments beginning 6 hours prior to starting fenoldopam or placebo infusion. The first dose of indomethacin will be given 12 hours after starting fenoldopam or placebo. Two additional doses of indomethacin will be given 12 hours apart. Urine will continue to be collected and volume measured in 6 hour increments up to 24 hrs after the last dose of indomethacin. To summarize, urine will be collected and measured from time -6 hours to 0 hours. Fenoldapam or placebo will be initiated at time 0 hrs, indomethacin given at time 12, 24 and 36 hours, and urine collected and measured to time 60 hours. == 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin, Serum Levels of Fenoldopam During Infusion of the Drug and Following Discontinuation of the Drug Will be Measured by Liquid Chromatography and Mass Spectroscopy. == Blood samples for determination of serum fenoldopam levels will be obtained immediately prior to starting the infusion of fenoldopam (time 0 hour), continue through the 48 hour period of fenoldopam infusion and continue for an additional 12 hours after stopping the fenoldopam infusion. == 60 hours, Change in Levels of Serum Albumin (mg/dl) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Changes in Serum Creatinine (mg/dl) == Serum creatinine will be measured immediately prior to first dose of indomethacin, immediately prior to the third dose of indomethacin (24 hr later) and 24 hours after the third dose of indomethacin == 48 hours, Serum Levels of Fenoldopam Will be Related the Changes in Urine Volume == We will relate serum levels of fenoldopam to changes in urine volume over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis == 60 hours, Serum Levels of Fenoldopam Will be Related to Absolute and Relative Changes in Serum Creatinine == We will relate serum levels of fenoldopam to serum creatinine values over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis == 60 hours, Change in Levels of Serum Beta 2 Macroglobulin (mcg/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Levels of Serum Cystatin C (mcg/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Levels of Serum Epidermal Growth Factor (EGF) (ng/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Levels of Serum Osteopontin (ng/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Levels of Serum Uromodulin (mg/dl) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Level of Urine Albumin (mg/dl) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hr, Change in Level of Urine Beta 2 Macroglobulin (mcg/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Level of Urine Cystatin C (mcg/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hr, Change in Levels of Urine Epidermal Growth Factor (EGF) (ng/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hr, Change in Levels of Urine Osteopontin (ng/ml) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs, Change in Levels of Urine Uromodulin (mg/dl) == Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period == 48 hrs
#> 25 Definite or probable relapse within 21 days post-antibiotic completion as per protocol == Among participants who adhered to study protocol- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis. == From 0-21 days after the end of the planned antibiotic therapy, Definite or probable relapse within 21 days post-antibiotic completion as per intention to treat == Among all randomized patients- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis. == From 0-21 days after the end of the planned antibiotic therapy
#> 26 Plasma Concentration of Brivaracetam (BRV) Following First Dose on Day 1 == Pharmacokinetic blood samples were taken 0.5 to 1 hour, 2 to 4 hours, and 8 to 12 hours after the BRV infusion on Day 1 to determine the BRV plasma concentration. == Pharmacokinetic blood samples were taken 0.5 to 1 hour, 2 to 4 hours, and 8 to 12 hours after the BRV infusion on Day 1
#> 27 Late onset sepsis (LOS) in Low Birth Weight. == Reduction in late onset sepsis (LOS) in Low Birth Weight babies. == 1 month, Optimal dosage of bLF == Deduce optimal dosage of bLF in LBW babies. == 1 month
#> 28 Vitamin levels == Change from baseline level of vitamin A, vitamin D, and vitamin E at 4~6 weeks == within 72 hours after birth, 4~6 weeks old
#> 29 duration of respiratory support in preterm neonates receiving early caffeine citrate == preterm neonates of gestational age 33 weeks or less needing any respiratory support (CPAP , mechanical ventilation....)were given caffeine citrate at the start of the support. duration of the support was compared to the duration of respiratory support in the other arm that includes preterm neonates of gestational age 33 weeks or less needing any respiratory support and receiving caffeine citrate 6 hours before weaning only. == throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of
#> 30 Early Mortality Rate == Neonates in the treatment group should have lower mortality rate in the first week of life == 1 week
#> 31 Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial) == supplementation of Vitamin D == nearly 4 years