Analyze subject waterfall chart data
The subject waterfall chart visually represents changes in lab results across individual subjects, often depicted as bars that indicate improvements or deteriorations. This methodology allows for a clear understanding of response patterns across the population, quickly illustrating the overall impact of treatment on lab tests.
In EDC, the Subject Waterfall chart is represented with a bar char. The bar chart is a graphical representation of data using rectangular bars to show the magnitude of different categories or groups. In the Subject Waterfall chart, the bars help in visualizing the cumulative effect of sequentially introduced positive or negative values. It is particularly useful for understanding how an initial value is modified by a series of increases and decreases.
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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 Subject Waterfall chart data. For this, hover over the bars to view the tooltips and comparing different values for different categories of data where relevant.
Figure 4. Reviewing CCTAE counts chart data
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Now from the chart, select Detail
. In the table that opens, analyze the subject waterfall details as explained in the following table.
Figure 5. Reviewing subject waterfall chart 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 is 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.
Site Code
Represents the unique identifier assigned to each participating site involved in the study.
Subject ID
Represents the unique identifier assigned to each participant involved in the study.
Statistical Methods
Represents the statistical techniques employed to analyze the data within each group. Common methods for the bar chart include the following:
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Min: represents the lowest observed data point in the dataset. In the bar chart, this value is indicated by the lower end of the bar and helps identify the range of the data.
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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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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.
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 heath 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 Subject Waterfall chart, select 
to close the table and return to the
chart view.