ICH Numbering

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Data Listings

The following are the ICH sections for Section 16.2, data listings. Heading numbers (e.g., 16.2.1), are standard/required for the CSR. Examples are provided for listings to be included in each section.

16.2 Patient Data Listings
16.2.1 Patient Discontinuations/Completions
Data Listing 16.2.1: Study Termination Information

16.2.2 Protocol Deviations
Data Listing 16.2.2.1: Inclusion Criteria
Data Listing 16.2.2.2: Exclusion Criteria
Data Listing 16.2.2.3: Inclusion/Exclusion Comments
Data Listing 16.2.2.4: Protocol Deviations

16.2.3 Patients Excluded from the Efficacy Analyses
Data Listing 16.2.3: Patients Excluded from Efficacy Analysis

16.2.4 Demographic Data and Other Baseline Characteristics
Data Listing 16.2.4.1: Demographic and Baseline Information
Data Listing 16.2.4.2: Medical History
Data Listing 16.2.4.3: Baseline Disease Characteristics

16.2.5 Compliance and/or Drug Concentration Data
The following listings are included in this section:
Data Listing 16.2.5.1: Study Drug Administration

16.2.6 Individual Efficacy Response Data
Data Listing 16.2.6.1: Efficacy Results

16.2.7 Adverse Event Listings (by Patient)
Data Listing 16.2.7.1: Adverse Events for Each Patient
Data Listing 16.2.7.2: Adverse Events Sorted by System Organ Class, Preferred Term and Patient

16.2.8 Laboratory Values (by Patient)
Data Listing 16.2.8.1: Hematology Laboratory Evaluations
Data Listing 16.2.8.2: Clinical Chemistry Laboratory Evaluations
Data Listing 16.2.8.3: Urinalysis Laboratory Evaluations
Data Listing 16.2.8.4: Patients with Clinically Significant Laboratory Values

16.2.9 Other Clinical Observations and Measurements (by Patient)
Data Listing 16.2.9.1: Concomitant Medications
Data Listing 16.2.9.2: Vital Signs Measurements
Data Listing 16.2.9.3: Physical Examination
Data Listing 16.2.9.4: Neurological Examination

Summary Tables

The following are the ICH sections for Section 14, tables referred to but not included in the text. Heading numbers (e.g., 14.1), are standard/required for the CSR. Examples are provided for types of tables and table numbering to be included in each section.

14 SUPPORTIVE TABLES AND FIGURES REFERRED TO BUT NOT INCLUDED IN THE TEXT
14.1 Demographic Data Summary Tables
To include demographics, baseline characteristics, disposition and exposure tables
Number as 14.1.1, 14.1.2, 14.1.3, etc.

14.2 Efficacy Data Summary Tables
To include all efficacy tabulations
Number as 14.2.1, 14.2.2, 14.2.3, etc.

14.3 Safety Data Summary Tables
14.3.1 Displays of Adverse Events
To include all adverse event tables
Number as 14.3.1.1, 14.3.1.2, 14.3.1.3, etc.

14.3.2 Listings of Deaths, Other Serious and Significant Adverse Events
Includes a list of patients
Number as 14.3.2.1, 14.3.2.2, 14.3.2.3

14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
No tables here

14.3.4 Abnormal Laboratory Value Listing (by Patient)
Includes a list of patients with abnormal lab values can be by patient or by lab test
Number as 14.3.4.1, 14.3.4.2, etc.

14.3.5 Laboratory Data Summary Tables
All laboratory tabulations (descriptive, shifts, etc)
Number as 14.3.5.1, 14.3.5.2, etc.

14.3.6 Other Safety Data Summary Tables
To include other safety tables such as vital signs, ECG data, PE data etc.
Number as 14.3.6.1, 14.3.6.2