Table 5 Variables for data extraction
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 | |