Analyze mean change time trends
The mean change time trend charts illustrates the average changes in lab test results over specific time intervals. This graph helps identify patterns or significant fluctuations in lab performance over the study duration, aiding in the evaluation of treatment efficacy or disease progression.
In EDC, the Mean Change Time Trends chart is comprised of the vertical lines represents statistical measurements of a dataset drawn vertically on the chart. The central part represents the median, with the lower and upper edges indicating the floor and ceiling, respectively. On the other hand, the bar chart represents the average changes in the lab tests over specified time points or intervals during the study. Additionally, the chart also represents a baseline that cuts through the vertical lines. This line acts as a reference for the data points.
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In the EDC application header, select the DASHBOARD tab.
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On the page that opens, select the Lab Test Analytics tab.
Figure 2. Accessing lab test analytics dashboard
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On the workspace toolbar, from the Lab Test dropdown menu, select the lab test that you want to review.
Figure 3. Selecting lab test to review
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On the Lab Test Analytics dashboard that opens, start analyzing the Mean Change Time Trends chart data. For this, hover over the lines and bars to view the tooltips and comparing different values for different categories of data where relevant.
Figure 4. Reviewing mean change time trends chart data
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Now from the chart, select Detail
. In the table that opens, analyze the mean change time trends details as explained in the
following table.
Figure 5. Reviewing mean change time trends details
Tip
To enlarge the table view, from the chart, switch to the Full Screen
mode.Column
Details
Group By - Country
Represents the grouping variable for the analysis, which in this case, is country. This parameter categorizes the data based on different countries, allowing for comparative analysis of outcomes, behaviors, or characteristics across the geographic regions.
Statistical Methods
Represents the statistical techniques employed to analyze the data within each group. Common methods for the mean change time trends include the following:
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Max: represents the highest observed data point in the dataset. In the mean change time trends, this value is indicated by the upper line and helps identify the range of the data.
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Min: represents the lowest observed data point in the dataset. In the mean change time trends, this value is indicated by the lower line and helps identify the range of the data.
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Median: represents the middle values of the dataset when it is ordered from lowest to highest. In a box plot chart, it is represented by a line within the box, dividing the box into two equal halves.
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Mean: represents the average value of the dataset, calculated by summing all the values and dividing by the number of observations. This value provides a measure of central tendency, which can complement the median.
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Std Dev (standard deviation): represents the amount of variation or dispersion in the dataset. This value is often referenced to understand the variability of the data.
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N (sample size): represents the total number of observations or data points in the dataset. It is essential for understanding the statistical significance of the results presented in the box plot.
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Baseline Mean: represents the average value of the lab test results collected at the beginning of the study before any treatment is administered. This statistic serves as a reference point for evaluating changes in lab results over time.
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Mean Change from Baseline: represents the average difference between the lab test results at subsequent time points and the baseline values. This statistic is crucial for assessing the overall effect of treatment by showing how much the results have improved or declined compared to the initial measurements.
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Max Change from Baseline: represents the largest observed change in the lab test results relative to the baseline values during the study. This statistic highlights the greatest improvement or deterioration experienced by any patient.
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Min Change from Baseline: represents the smallest observed change in the lab test results compared to the baseline values throughout the study. This statistic helps identify the least favorable changes experienced by the participant and can indicate potential negative effects of treatment in individual responses.
All Visit
Represents the total count of visits or observations included in the analysis for each group. This count is important for assessing the reliability and validity of the findings presented in the analysis.
Screening
Represents the statistics gathered during the screening phase of the study. It includes baseline lab test results collected before participants are enrolled in the trial.
This data is crucial for determining eligibility and establishing the initial health status of the subject.
C1D1 (Cycle 1, Day 1)
Represents the lab test results collected on the first day of the first treatment cycle. This column summarizes essential statistics, such as mean, median, and other measures, reflecting the subject's lab values immediately before or after the initiation of the treatment.
EOT (End of Treatment)
Represents the lab test results collected at the end of the treatment phase for the study participants. This statistic is essential for accessing the final health status of the subjects after completing the assigned treatment regimen.
The EOT metrics are often compared to the baseline and interim values to evaluate the treatment's efficacy and to observe any lasting effects or improvement in the lab test results.
Unscheduled Visit.1 (n+1)
Represents the statistics from the first unscheduled visit, which occurs outside of the predefined study schedule. It includes the lab test results that may have been collected due to patient-reported issues or adverse events.
This chart may have more than one unscheduled visits. These visits reflect additional lab test results that are collected outside the regular visit schedule, aiding in the assessment of any changes in the subject's health status as the trial progresses.
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Once you have analyzed the details of the Mean Change Time Trends chart, select 
to close the table and return to
the chart view.