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Table 5 Variables for data extraction

From: Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer

Arm-phase-period information by study arm and overall
Arm Unique arm number. Unique number for the treatment arm is a grouping variable that is used to highlight which outcome is in the same group of subjects Integer, in case of sub-analysis arm use A.a format. Placebo = 0, for sub-arm 0.1
Number of study arms   1, 2, 3
Open label versus blinded   
Phase of study   1, 2, 3, or unknown
Objectives   OS, PFS, RR, TPD, etc.
Patients randomized Number of patients randomized to the arm Number value
Arm description Description of the treatment arm usually includes the drug name, dose, and frequency e.g., methotrexate 10 mg QW (once a week)
Sub arm analysis Indicates if the analysis is in a subset of study arm Yes, NA. Use all in case of AE or dropout data is reported for the randomized trial population
Arm comment Comment referring to the arm Comment in relevance to the understating of arm or NA
Study phase Description of the specific phase within the overall study from which the data is derived Lead-in, active, follow-up
Study phase description Qualifies the "Study Phase" field with any additional information deemed necessary or helpful for that arm e.g., open-label follow-up
Phase duration Length of time of the study phase from which the data is derived for the arm Time
Phase duration unit Time unit for phase duration for the arm Units
Phase comment Comment concerning the study phase Any comment that is relevant to the understanding of the phase or NA
Period Used if necessary to separate crossover periods within a crossover trial If the phase has multiple periods, the number of the period. Integer in sequence, or NA
Period description Used to qualify the "Period" field with any additional information deemed necessary or helpful e.g., treatment A, titration, maintenance, NA
Period duration Length of time of the period in a study phase from which the data is derived Time, NA
Period duration unit Time unit for period duration Units, NA
Period comment Comment concerning the period Any comment that is relevant to the understanding of the period or NA
Repository Description Data entry standards
Demographics and medical history information at baseline by study arm and overall—adjusted and unadjusted
Age Mean (or median) age in years of patient population or treatment arm population Age in years or NR if not mentioned specifically or clearly in the trial
Percent female Percent of females in the patient population or treatment arm population Percent or NR if not mentioned specifically or clearly in the trial
Weight Mean body weight of the patient or treatment arm population Weight in kg, normalize if needed or NR if not mentioned specifically or clearly in the trial
Height Mean height of the patient or treatment arm population Height in cm, normalize if needed or NR if not reported
BMI Mean body mass index of the treatment arm population BMI in kg/m2, normalize if needed or NR if not reported in the trial
DBP Mean (or median) diastolic blood pressure mmHg
SBP Mean (or median) systolic blood pressure mmHg
Inclusion Description of treatment arm or sub-arm inclusion criteria under the trial protocol e.g., for sub-group females only, or NR if not mentioned specifically or clearly in the trial
Exclusion Description of treatment arm or sub-arm exclusion criteria under the trial protocol e.g., for sub-group exclusion of females with child-bearing potential, or NR if not mentioned specifically or clearly in the trial
Ethnic white Percent of the ethnic population who are whites or Caucasian in the trial Percent or NR if not mentioned specifically or clearly in the trial
Ethnic black Percent of the ethnic population who are black in the trial Percent or NR if not mentioned specifically or clearly in the trial
Ethnic Hispanic Percent of the ethnic population who are Hispanic in the trial Percent or NR if not mentioned specifically or clearly in the trial
Ethnic Asian Percent of the ethnic population who are Asian in the trial Percent or NR if not mentioned specifically or clearly in the trial
Ethnic other Percent of the ethnic population who are other in the trial Percent or NR if not mentioned specifically or clearly in the trial
Primary disease Primary disease being studied  
Percent current smokers Percent of the population who are current smokers Percent or NR if not mentioned specifically or clearly in the trial
Percent previous smokers Percent of the population who are previous smokers Percent or NR if not mentioned specifically or clearly in the trial
Percent adenocarcinoma type Percent subjects with NSCLC adenocarcinoma type Percent or NR if not mentioned specifically or clearly in the trial
Percent squamous cell carcinoma type Percent subjects with NSCLC squamous cell carcinoma type Percent or NR if not mentioned specifically or clearly in the trial
Percent non-squamous   
Percent NSCLC stage 0/ I/ II Percent subjects with NSCLC stage 0 or I or II Percent or NR if not mentioned specifically or clearly in the trial
Percent NSCLC stage III Percent subjects with NSCLC stage III Percent or NR if not mentioned specifically or clearly in the trial
Percent NSCLC stage IV Percent subjects with NSCLC stage IV Percent or NR if not mentioned specifically or clearly in the trial
Percent NSCLC stage III/IV total Total percent of subjects with NSCLC stages III or IV Percent or NR if not mentioned specifically or clearly in the trial
Percent ECOG status 0 Percent subjects with Eastern Cooperative Oncology Group performance status scale 0 Percent or NR if not mentioned specifically or clearly in the trial
Percent ECOG status 1 Percent subjects with Eastern Cooperative Oncology Group performance status scale 1 Percent or NR if not mentioned specifically or clearly in the trial
Percent ECOG status 0/1 total Percent subjects with Eastern Cooperative Oncology Group performance status scales 0 or 1 Percent or NR if not mentioned specifically or clearly in the trial
Percent Karnofsky status ≥80 Percent subjects with Karnofsky’s index of performance status >80% Percent or NR if not mentioned specifically or clearly in the trial
Percent WHO performance status 0/1 Percent subjects with WHO performance status scale 0 or 1 Percent or NR if not mentioned specifically or clearly in the trial
Num of metastatic lymph nodes Mean or median number of metastatic lymph nodes NR if not mentioned specifically or clearly in the trial
Percent metastatic L-node positive Percent subjects who are lymph node positive or with metastatic lymph nodes Percent or NR if not mentioned specifically or clearly in the trial
Percent bone metastasis Percent subjects with bone metastasis Percent or NR if not mentioned specifically or clearly in the trial
Percent brain metastasis Percent subjects with brain metastasis Percent or NR if not mentioned specifically or clearly in the trial
Percent liver metastasis Percent subjects with lung metastasis Percent or NR if not mentioned specifically or clearly in the trial
Percent other metastasis Percent subjects with other metastatic organs Percent or NR if not mentioned specifically or clearly in the trial
Percent metastatic organ sites 1 Percent subjects with one metastatic organ or site involved Percent or NR if not mentioned specifically or clearly in the trial
Percent metastatic organ sites 2 Percent subjects with two metastatic organs or sites involved Percent or NR if not mentioned specifically or clearly in the trial
Percent metastatic organ sites >3 Percent subjects with three or more metastatic organs or sites involved Percent or NR if not mentioned specifically or clearly in the trial
Percent hemoglobin <11.5 g/dl Percent subjects with baseline hemoglobin levels <11.5 g/dl Percent or NR if not mentioned specifically or clearly in the trial
Patient demographic comments Any pertinent demographic comments that are not dealt by other variables Any comment that may be relevant to the understanding of the demographic characteristics of the patient population
Percent previous surgery Subjects with previous treatment for NSCLC as complete or partial surgery. Procedures include wedge resection (removal of part of a lobe), segmentectomy (removal of an anatomic division of a particular lobe of the lung), lobectomy (one lobe), bilobectomy (two lobes), or pneumonectomy (whole lung) Percent or NR if not mentioned specifically or clearly in the trial
Percent previous radiotherapy Percent subjects with previous radiotherapy as treatment for NSCLC Percent or NR if not mentioned specifically or clearly in the trial
Percent previous chemotherapy Percent subjects with previous chemotherapy as treatment for NSCLC Percent or NR if not mentioned specifically or clearly in the trial
Comorbidities   At baseline and by treatment arm
Percent comorbidities   At baseline and by treatment arm;% or NR
Percent previous platinum   
Percent no previous treatment Percent subjects with no treatment for NSCLC Percent or NR if not mentioned specifically or clearly in the trial
Previous treatment comments Comments regarding the previous treatment Any comment that may be relevant to the understanding of the previous NSCLC treatment in this record, NA if no comments
Pharmacological therapy information
Repository Description Data entry standards
Primary NSCLC therapy Name of primary drug therapy used in this arm at that time point NSCLC drug, e.g., cisplatin, docetaxel
Primary NSCLC dose Randomized daily dose at time of outcome. Please note that this is the dose the patients were receiving when the observation is made (not the first randomized dose). If the treatment is switched at the time of observation, record the prior treatment the patients were getting just before the observation was made Total daily dose at the time of observation
Primary NSCLC dose achieved Average daily dose during assessment period or for the total treatment period Average daily dose achieved. Specifically useful for dose titration and crossover trials, NA for the fixed dose trials as both dose achieved and total daily dose do not vary
Primary NSCLC dose unit Unit of total daily or average dose achieved Unit, NR if not reported
Primary NSCLC dose freq/cycle   
Primary Rx days of administration   e.g., d1, d8
Primary therapy duration and route of administration   e.g., 10 min i.v. infusion
Primary NSCLC Rx cycle duration   
Primary NSCLC Rx number of cycles   
Primary NSCLC formulation Special treatment formulation Only specialized formulations like IR, CR, SR
Primary NSCLC therapy status Indicates whether the observation refers to the first, continuing or last dose of the therapy Start = first dose starts on at this time, continuing = treatment is continuing at this time, end = treatment has been discontinued at this time (last dose)
Primary NSCLC dose comments Comment regarding the dosing of primary NSCLC treatment Any comment that may be relevant to the understanding the dosing of the primary treatment in this record, NA if no comments
Combo NSCLC therapy Name of secondary NSCLC therapy used in this arm in addition to the primary treatment at that time point NSCLC drug, e.g., PTH NA if no secondary NSCLC therapy
Combo NSCLC dose Randomized daily dose of the secondary NSCLC therapy at time of outcome. Refer to the dose description of primary NSCLC dose Total daily dose at the time of observation, NR if not reported and NA if no secondary NSCLC therapy
Combination NSCLC dose achieved Average daily dose of the secondary NSCLC therapy during assessment period or for the total treatment period Average daily dose achieved. Specifically useful for dose titration and crossover trials, NA for the fixed dose trials as both dose achieved and total daily dose do not vary
Combination NSCLC dose unit Unit of total daily or average dose achieved for the secondary NSCLC therapy Unit, NR if not reported or NA if no secondary NSCLC therapy
Combination NSCLC dose reg Frequency of secondary NSCLC therapy being administered QD, BID, etc., NA if no secondary NSCLC therapy
Combination NSCLC dose freq/cycle   
Combination Rx days of administration   e.g., d1, d8
Combination Rx duration and route of administration   e.g., 10 min i.v. infusion
Combination NSCLC Rx cycle duration   
Combination NSCLC Rx number of cycles   
Combination NSCLC dose comment Comment regarding the dosing of secondary NSCLC therapy Any comment that may be relevant to the understanding the dosing of the secondary treatment in this record, NA if no comments or no secondary NSCLC therapy
Concomitant medications   Baseline or by treatment arm
Radiation therapy information
Repository Description Data entry standards
Radiation therapy type   
Radiation therapy comments   
Assessment characterization
Repository Description Data entry standards
Assessment Common name for assessment that this record refers to, e.g., PANSS As in the assessments and conventions sheet
Assessment short form Code for the assessment As in the assessments and conventions sheet
Assessment comment Any comment that describes the nature of the assessment e.g., plasma glucose level, NA if no comments
Assessment location Location from where the assessment value is taken or extracted from the manuscript Table number, figure number, page number
Assessment category Describes what the assessment value represented is, whether it is absolute, change from baseline (CFB), percent change from baseline (PCFB), or fraction of randomized patients with the event, count in case of tender or swollen joint counts Absolute, CFB, PCFB, Frac, or Count
Assessment Stat parameter The summary parameter of the assessment value Mean, median, percent, NR if not reported
Stat population Statistical population for which the efficacy/safety analyses were done and value reported ITT, OC, completers, randomized, PPP (per protocol population: define), NR if not reported
Missing data treatment Method used for handling with missing observations in computing the summary parameter LOCF (last observation carried forward), none, NR if not reported and NA in case of completers
Scale lower limit Scale lower limit The lower limit of the scale for the assessment, NA if not applicable
Scale upper limit Scale upper limit The upper limit of the scale for the assessment, NA if not applicable
Assessment categories or words Scale category description Category that is associated with each point of the scale
Total levels Total categories/points in the scale The total number of categories associated with each point of the scale, e.g., 0 to 4 point scale
Total symptoms Total symptoms in the scale The total number of symptoms associated with the respective assessment, NA if not applicable
Total score lower limit Lower limit of the scale, this is calculated as the number of levels multiplied with the lowest possible scale Integer value, NA if not applicable
Total score upper limit Upper limit of the scale, this is calculated as the number of levels multiplied with the highest possible scale Integer value, NA if not applicable
Assessment level For ordered categorical data "scales." Indicates which level in the categorical scale the assessment is referring to Integer level from 1 to number of levels, if fractional responder type, enter responder threshold value, eg., ≥5% weight loss from baseline for total body weight assessment, etc., NA if not applicable
PROs Scale, mean value, SD by group, time point  
Time, assessment, and baseline value information
Repository Description Data entry standards
Assessment visit Clinical visit at which the assessment is done Visit 1 (usually baseline) is the first visit in the active phase. Lead in visits start at -1 and count backwards, NR if not reported
Assessment time reported Time at which the assessment is done during the study and as reported in the manuscript Visit 1 = baseline = time 0 and the lead in assessment time starts at -1 and count backwards
Assessment time unit reported Unit for reported assessment time Time unit as reported
Assessment time range reported In case if the assessment values are average over a time interval e.g., weeks 2 through 28 enter 2–28
Assessment time normalized Normalized time in days at which the assessment is done during the study and as reported in the manuscript The normalized time value using the normalized unit as days, e.g., 4 weeks = 28 days
Assessment time unit normalized Unit for standard assessment time Days is the standard unit
Assessment value Assessment value reported at that time point Assessment value as reported
Assessment unit Assessment unit as reported Assessment unit as reported, NA if not applicable
Assessment SE SE of reported assessment value SE as reported, NR if not reported
Assessment SD SD of reported assessment value SD as reported, NR if not reported
Assessment CI type   
Assessment lower CI   
Assessment upper CI   
Assessment value normalized Assessment value converted into normalized assessment units Still insert value here, report if normalized units are the same as the reported units
Assessment value unit norm Normalized assessment value units See assessments and conventions sheet for normalized assessment standard
Assessment SE normalized Standard error of normalized assessment value SE in the same units as normalized assessment, may need to be calculated from SD and N; if not provided, NA
Assessment SD normalized Standard deviation of normalized assessment value SD in the same units as normalized assessment, may need to be calculated from SE and N; if not provided, NA
Assessment CI type normalized   
Assessment lower CI normalized   
Assessment upper CI normalized   
Assessment number Number of patients assessed at that time point and the value derived Integer value, but for responders and dropouts, this value is calculated from the percentages reported in the trial
Assessment value comment Comment pertaining to the assessment value that cannot be dealt by other variables e.g., the assessment value is the mean of last 7 days of before each clinical visit, etc.
Hazard ratio 95% confidence intervals, progression-free survival, and overall survival—adjusted and unadjusted  
Baseline visit Clinical visit at which the baseline assessment is done Visit 1 = baseline = time 0, NR if not reported
Baseline time Time at which the baseline assessment is done Visit 1 = baseline = time 0
Baseline time unit Unit for reported baseline time Time unit as reported
Baseline time normalized Normalized time in days at which the baseline is done during the study and as reported in the manuscript The normalized time value using the normalized unit as days, e.g., -4 weeks = -28 days
Baseline time unit normalized Unit for standard baseline time Days is the standard unit
Baseline value Absolute baseline value for that assessment Absolute baseline value
Baseline value unit Assessment unit as reported Assessment unit as reported, NA if not applicable
Baseline SE SE of the absolute baseline value SE as reported, NR if not reported
Baseline SD SD of the absolute baseline value SD as reported, NR if not reported
Baseline CI type   
Baseline lower CI   
Baseline upper CI   
Baseline value normalized Baseline value converted into normalized baseline units Still insert value here report if normalized units are the same as the reported units
Baseline value unit normalized Normalized baseline value units See assessments and conventions sheet for normalized assessment standard
Baseline SE normalized Standard error of normalized baseline value SE in the same units as normalized baseline, may need to be calculated from SD and N; if not provided, NA
Baseline SD normalized Standard deviation of normalized baseline value SD in the same units as normalized baseline, may need to be calculated from SE and N; if not provided, NA
Baseline CI type normalized   
Baseline lower CI normalized   
Baseline upper CI normalized   
Baseline N Number of patients from which the baseline value is derived Integer
Baseline value comment Comment pertaining to the baseline value that cannot be dealt by other variables e.g., the baseline value is the mean of last 7 days of the run in period
Reference specifications   
Repository Description Data entry standards
Ref code Numerical code assigned for the literature citation. Maps the record to the assessment details Integer
Protocol or trial number Protocol ID or the number of the trial report As reported, NA if not applicable
Date modified Date of initial entry or subsequent modification of the data point mmddyy format
Modified by Initials of curator  
Modification comment Any comment that is relevant to modification by the curator Initial entry if new record, brief statement of change(s)
Copyright status Provided by the client or procured by the service provider Client provided or yes in case the manuscript is procured by the service provider
Author Authors of publication As reported
Journal Journal name Standard abbreviated forms can be used, generally as in the PubMed
Publication year Year of the publication Integer
Title Title of the study  
Volume Volume number of the publication e.g., 180
Pages Page numbers of the publication e.g., 1–24
Trial name alias Trial name that trial is commonly referred to NR if not reported
Inclusion description Provide description of inclusion criteria Can be cut and paste from PDF, can be placed in an attached note
Exclusion description Provide description of exclusion criteria Can be cut and paste from PDF, can be placed in an attached note
Study design Brief description of the study design Parallel-fixed arm, dose escalation, effect titration, crossover, etc.
Location of the trial Geographical location where the study is conducted Primary nationalities list
Number of countries Number of countries the study is conducted Integer
Number of centers Number of centers the study is conducted Integer
Trial start date Date when the trial started mmddyy format
Trial end date Date when the trial completed mmddyy format
Placebo-controlled or active comparator Was there a control group and was it placebo PBO control/active comparator
Active comparator therapy If this was an active comparator trial what was the comparator therapy e.g., PTH
Percent randomized to placebo Percent of subjects in the trial who are randomized to placebo Integer
Add-on/washout study Was the study drug added on to standardized background Rx, was background Rx washed out prior to starting primary Rx, or was standardized background therapy withdrawn once primary RX started Add-On, Washout, Replacement, None
Study blind Was the trial blinded for the treatment phase Yes, double blind
Number of arms Number of treatment arms the patients are randomized to Integer
Arm description Codes and description for arms 0 = placebo and others in sequence
Dose descriptions Brief descriptions of the treatment drugs and the respective doses along with regimens received 0 = placebo, 1 = metformin 10 mg QW…
Dose ranging within study Does the trial contain at least two primary treatment arms where different dose strengths were administered Yes, No. Placebo does not count as a dose strength
Primary longitudinal data Were multiple time values reported for the primary assessment endpoint Yes, No.
Active phase trial duration What was the duration of the active phase of the trial Time, units, i.e., 3 weeks
Steady state effect achieved? Does it appear that effect stabilized over time for primary endpoints Yes, No. Not clear
Was there a lead-in phase? Was there a standardized lead-in phase in the study other than a simple screening visit Yes, No
Lead-in phase duration If so, what was the duration If yes, time, units, i.e., 6 months. If no, 0
Was there a follow-up phase? Was there a standardized follow-up phase that at least some patients were enrolled in after the active phase ended Yes, No
Duration of follow-up phase If so, what was the duration If yes, time, units, i.e., 6 months. If no, 0
Primary endpoint What is the primary outcome or assessment reported in the trial e.g., HBA1C
Secondary endpoints   
Other efficacy endpoints available List of the other secondary efficacy or biomarker outcomes reported in the trial e.g., HOMA
Most frequent AEs (incidence) List the most frequently reported AE’s e.g., vomiting, nausea, headache, dizziness
Adverse events Grade,%, n by group, treatments for AEs, hospitalizations secondary to AEs and overall, ICU admissions secondary to AEs and overall  
Median and mean if reported Progression-free survival and overall survival in months (TTPD, TTTF)  
Survival rates Percent alive at X months  
Response rates At what time?  
Toxicity Number of individuals experiencing toxicity/treatment group