SUMMARY OF PREFERRED AND ALTERNATE OPTIONS SINGLE DIAGNOSIS DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS Single definitive diagnosis without Diagnosis (only possible option) Single provisional diagnosis without signs/symptoms Provisional diagnosis (only possible option) Single definitive diagnosis with Preferred: Diagnosis only Alternate: Diagnosis and Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 1 Single provisional diagnosis with signs/symptoms Preferred: Provisional diagnosis and Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 2 MULTIPLE DIAGNOSES DEFINITIVE DIAGNOSES PROVISIONAL DIAGNOSES Multiple definitive diagnoses without signs/symptoms Multiple diagnoses (only possible option) Multiple provisional diagnoses without signs/symptoms Multiple provisional diagnoses (only possible option) Multiple definitive diagnoses with signs/symptoms Preferred: Multiple diagnoses only Alternate: Diagnoses and signs/symptoms Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 3 Multiple provisional diagnoses with signs/symptoms Preferred: Multiple provisional diagnoses and signs/symptoms Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis SEE EXAMPLE 4 EXAMPLES
Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm 2 Possible myocardial infarction with pain, dyspnoea, diaphoresis Myocardial infarction Chest pain Dyspnoea Diaphoresis Chest pain Dyspnoea Diaphoresis 3 Pulmonary embolism, myocardial infarction, and congestive heart failure with chest pain, cyanosis, shortness of breath, and blood pressure decreased Pulmonary embolism Myocardial infarction Congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath pressure decreased 4 Pulmonary embolism
Reported LLT Selected Comment Death due to myocardial infarction Myocardial infarction Record death as an outcome Constipation, ruptured bowel, peritonitis, sepsis; patient died Constipation Perforated bowel Peritonitis Sepsis Death as the only reported information If the only information reported is death, select the most specific death term available. Circumstances of death should not be inferred but recorded only if stated by the reporter. Death terms in MedDRA are linked to HLGT Fatal outcomes. Example Reported LLT Selected Patient was dead Found dead Patient died in childbirth Maternal death during childbirth The autopsy report stated that the cause of death was natural Death from natural causes Death terms that add important clinical information Death terms that add important clinical information should be selected along with any reported ARs/AEs. Example Reported LLT Selected Patient experienced a rash and had sudden cardiac death Rash Sudden cardiac Other patient outcomes (non-fatal) Hospitalisation, disability, and other patient outcomes are not generally considered ARs/AEs. Example
LLT PT abuse Child abuse Child abuser Elder abuse abuse Elder abuser (See Section 3.24.2 concerning illegal/criminal acts.) Illegal acts of crime or abuse Terms for illegal acts of crime and abuse (excluding those related to drug/substance abuse) are in SOC Social circumstances, such as LLT Physical assault. LLTs representing the perpetrator are linked to PTs describing the unlawful act committed. PTs representing the victim of unlawful acts generally begin with “Victim of… ”. Example Reported LLT Selected Comment Patient’s history indicates that patient is a known sexual offender Sexual offender Perpetrator; LLT Sexual offender links to PT Sexual abuse in SOC Social circumstances Patient was a childhood sexual assault victim Childhood sexual assault victim Victim; LLT Childhood sexual assault victim links to PT Victim of sexual abuse in SOC Social circumstances Medical and Social History Example Reported LLT Selected History of gastrointestinal bleed Gastrointestinal bleed
Hypertension; this is off label use Hypertension Hypertension Example Reported LLT Selected Used off label Off label use Example Reported LLT Selected Comment Drug indicated for use in adults used off label to treat a 6 year old child Off label use Adult product administered to child LLT Adult product administered to child (PT Drug administered to patient of inappropriate age, HLT Product administration errors and issues) provides additional information about the specific type of off label use. The term is not an off label use term itself; it is a general product use issue term that can be used in combination with other terms to capture detail about off label use, misuse, medication errors, etc. Off label use when reported with an AR/AE If an AR/AE occurs in the setting of off label use for a medical condition/indication, the preferred option is to select a term for off label use, and a term for the medical condition/indication in addition to a term for the AR/AE. Alternatively, select a term for the medical condition/indication and a term for the AR/AE. Example
Transition Date for the Next MedDRA Version * Requires user ID and password to access Membership of the ICH Points to Consider Working Group Current members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Maria Luisa Casini Kavita Chadda European Federation of Pharmaceutical Industries and Associations Christina Winter* Health Canada Pritchett Lynn Macdonald Japanese Maintenance Organization Yutaka Kazuyuki Sekiguchi Mitsuru Takano Tomoko Narita Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita Miyako Shionoiri MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Miki Ohta Kiyomi Ueno Pharmaceutical Research and Manufacturers of America Milbhor US Food and Drug Administration Sonja Brajovic#