MedDRA Version 11.0 Specific Changes
Changes In a Nutshell
Complex Changes
There were no changes at
the SOC level. There was a capitalization change in one HLGT term and
several changes at the HLT level, presented below.
HLGT level:
Renamed – modified HLGT name
|
HLGT Name v 10.1 |
HLGT Name v 11.0 |
|
Movement disorders (incl Parkinsonism) |
Movement disorders (incl parkinsonism) |
HLT
level: There are 13 new HLTs added and 7 HLTs merged as a result of
the
complex changes in
Version 11.0. They are as follows:
New HLTs:
|
New HLT v 11.0 |
To HLGT |
|
Bone marrow and immune tissue
histopathology procedures |
Haematology investigations (incl blood
groups) |
|
Bone marrow and immune tissue imaging
procedures |
Haematology investigations (incl blood
groups) |
|
Fear symptoms and phobic disorders (incl
social phobia) |
Anxiety disorders and symptoms |
|
Haematological cysts and polyps |
Haematopoietic neoplasms (excl leukaemias
and lymphomas) (multi-axial HLGT) |
|
Hepatobiliary cysts and polyps |
Hepatic and biliary neoplasms benign |
|
Leukodystrophies |
Demyelinating disorders |
|
Nervous system cysts and polyps |
Nervous system neoplasms benign
(multi-axial HLGT) |
|
Ocular cysts and polyps |
Ocular neoplasms
(multi-axial HLGT) |
|
Panic attacks and disorders |
Anxiety disorders and symptoms |
|
Parathyroid histopathology procedures |
Endocrine investigations (incl sex
hormones) |
|
Renal neoplasms malignant |
Renal and urinary tract neoplasms malignant
and unspecified |
|
Skin cysts and polyps |
Cutaneous neoplasms benign (multi-axial
HLGT) |
|
Thyroid histopathology procedures |
Endocrine investigations (incl sex
hormones) |
Merged HLTs:
|
Changed HLT |
Merged under |
|
Bone marrow and immune tissue analyses |
Merged under HLT: Bone marrow and immune
tissue histopathology procedures |
|
Fear symptoms |
Merged under HLT: Fear symptoms and phobic
disorders (incl social phobia) |
|
Non-renal cell kidney neoplasms malignant |
Merged under HLT: Renal neoplasms malignant |
|
Panic disorders |
Merged under HLT: Panic attacks and
disorders |
|
Panic symptoms |
Merged under HLT: Panic attacks and
disorders |
|
Renal cell carcinomas |
Merged under HLT: Renal neoplasms malignant |
|
Specific and social phobic disorders |
Merged under HLT: Fear symptoms and phobic
disorders (incl social phobia) |
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‘Injury and ‘Damage’ terms
Injury and damage concepts were discussed by a MedDRA Expert Panel.
Based on this, injury and damage terms in MedDRA will now be considered
generally as synonymous. Injury or damage to a major organ that is not
of a traumatic causality will be placed primary to the location. If the
causality is “due to accident”, the term will be linked primary to SOC
Injury, poisoning and procedural complications.
Following this guidance some liver injury terms were realigned.
PT Cholestatic liver injury, PT Mixed liver injury, and PT
Liver injury are
considered non-traumatic and are primarily linked to SOC
Hepatobiliary disorders while
PT Traumatic liver injury is primarily linked to SOC Injury,
poisoning and procedural
complications.
A
review of pregnancy and injury terms in Version 11.0, based on Points to
Consider
working group change requests, resulted in terms involving fetal
exposure to drugs and
other substances (e.g., tobacco) in MedDRA to be linked primary to SOC
Injury,
poisoning and procedural complications, with a secondary link to
SOC Pregnancy,
puerperium and perinatal conditions. Terms directly attributable
to birth trauma events
are primarily linked to
SOC Pregnancy, puerperium and perinatal conditions.
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New SMQs
MedDRA version 11.0 contains 58 SMQs. There
are 3 which are new in this version:
1. Ischaemic colitis (SMQ)
2. Haemodynamic oedema, effusions and fluid overload (SMQ)
3. Glaucoma (SMQ)
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Back to MedRA 11.0 Review
|
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