21 June 2018 EMA/CVMP/PhVWP/272687/2018 Committee for Medicinal Products for Veterinary Use
List of changes to combined VeDDRA list of clinical terms
1
Application site vasoconstriction
1107
Application site vasoconstriction
2671
1: A: animal; C: common; H: human 2: A: addition; D: deletion; M: modification
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
An agency of the European Union
Current Term Type1
New LLT Key
New LLT
Current LLT Key
Current Low Level Term (LLT)
New PT Key
New PT Term
Current PT Key
Current Preferred Term (PT)
New HLT Key
New HLT Term
Current HLT Key
New SOC Key
Current High Level Term (HLT) Application site reactions
Action2
1
New SOC Term
Current SOC Key
Application site disorders
New Term Type1
1
Current System Organ Class (SOC) Term
Change no.
For reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2018
C
A
Current Term Type1
New Term Type1
Action2
Inappropriate elimination NOS
2674
C
A
137
Hypovolaemic shock
2675
C
A
Phlebitis
151
Thrombophlebitis
2676
C
A
Intestinal stasis
628
Hard stool
2677
C
A
3
Behavioural disorders
2
Other behavioural disorders
6
4
Behavioural disorders
2
Other behavioural disorders
6
5
Cardiovascular system disorders
4
Circulatory disorders
24
Circulatory shock
6
Cardiovascular system disorders
4
Vascular disorders
27
7
Digestive tract disorders
5
Intestinal disorders
236
2
Hyperactivity
1108
73
Inappropriate elimination NOS
1109
Puncture wound
2672
Unsettled
New LLT
New LLT Key
A
Puncture wound
Current LLT Key
C
3
New PT Key
2673
Injection site reactions
New PT Term
M
1
Current PT Key
H
Application site disorders
1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key
New HLT Term
Current HLT Key
Current High Level Term (HLT)
New SOC Key
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no.
C
2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 2/41
Action2
Endocrine system disorders
7
Thyroid gland disorders
51
Thyroid gland disorder NOS
251
Enlarged thyroid gland
2679
C
A
10
Endocrine system disorders
7
Thyroid gland disorders
51
Thyroid gland disorder NOS
251
Goitre
2680
C
A
11
Immune system disorders
10
Autoimmune disorders
70
Immunemediated polyarthropathy
1110
Immunemediated polyarthritis
2681
C
A
12
Immune system disorders
10
Autoimmune disorders
70
Immunemediated polyarthropathy
1110
Immunemediated polyarthropathy
2682
C
A
13
Systemic disorders
19
General signs or symptoms
154
Abnormal cytology
1089
1 2
Investigations
34
Abnormal cytology
26 4
Abnormal test result
666
Abnormal cytology
2588
New LLT Key
9
New LLT
A
Current LLT Key
C
New PT Key
2678
New PT Term
Reduced faecal output
Current PT Key 628
New HLT Key
Intestinal stasis
New HLT Term
236
Current HLT Key
Intestinal disorders
New SOC Key
5
New SOC Term
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term Digestive tract disorders
Change no. 8
C
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 3/41
2070
15
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Abnormal imaging
26 6
Abnormal test result
666
Abnormal ultrasound finding
1093
Abnormal ultrasound finding
2069
16
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Abnormal necropsy
26 5
Abnormal test result
666
Abnormal necropsy finding
1090
Abnormal necropsy finding
2142
17
Investigations
34
Abnormal physical examination
27 0
Abnormal rectal palpation
18
Investigations
34
Adrenal investigations
25 3
19
Investigations
34
Adrenal investigations
25 3
Abnormal adrenocorticotropic hormone (ACTH) stimulation test Abnormal dexamethasone suppression test
Current SOC Key 1 2
2070
C
M
C
M
C
M
Action2
Abnormal radiograph finding
New Term Type1
1091
Current Term Type1
Abnormal radiograph finding
New LLT Key
666
Current LLT Key
Abnormal test result
New LLT
Current Low Level Term (LLT)
26 6
New PT Key
Abnormal imaging
New PT Term
Current Preferred Term (PT)
154
Current PT Key
New HLT Key
General signs or symptoms
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
19
Current System Organ Class (SOC) Term Systemic disorders
Change no. 14
NT - Abnormal necropsy finding NOS
2142
1111
Abnormal rectal palpation
2683
C
A
1042
Abnormal adrenocorticotropic hormone (ACTH) stimulation test
2663
C
A
1041
Abnormal dexamethasone suppression test
2662
C
A
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 4/41
Current Low Level Term (LLT)
2624
C
M
21
Endocrine system disorders
7
Investigations
34
Adrenal gland disorders
45
Adrenal investigations
25 3
Hypoadrenocorticism
237
Hypocortisolaemia
1044
Hypocortisolaemia
2625
C
M
22
Blood and lymphatic system disorders
3
Investigations
34
Bone marrow disorders
12
Bone marrow investigations
24 6
Bone marrow aplasia
89
Bone marrow hypoplasia
1022
Bone marrow aplasia
149
C
M
23
Blood and lymphatic system disorders
3
Investigations
34
Bone marrow disorders
12
Bone marrow investigations
24 6
Bone marrow aplasia
89
Bone marrow hypoplasia
1022
Bone marrow hypoplasia
2385
C
M
24
Blood and lymphatic system disorders
3
Investigations
34
Bone marrow disorders
12
Bone marrow investigations
24 6
Bone marrow aplasia
89
Bone marrow hypoplasia
1022
Bone marrow suppression
150
C
M
25
Blood and lymphatic system disorders
3
Investigations
34
Bone marrow disorders
12
Bone marrow investigations
24 6
Bone marrow aplasia
89
Bone marrow hypoplasia
1022
Pancytopenia
2114
C
M
Current SOC Key 1 2
Action2
Hypercortisolaemia
New Term Type1
1043
Current Term Type1
Hypercortisolaemia
New LLT Key
236
New LLT
Hyperadrenocorticism
Current LLT Key
25 3
New PT Key
Adrenal investigations
New PT Term
Current Preferred Term (PT)
45
Current PT Key
New HLT Key
Adrenal gland disorders
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
7
Current System Organ Class (SOC) Term Endocrine system disorders
Change no. 20
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 5/41
Current Low Level Term (LLT)
M
27
Blood and lymphatic system disorders
3
Investigations
34
Bone marrow disorders
12
Bone marrow investigations
24 6
Bone marrow disorder NOS
877
Bone marrow disorder NOS
1882
C
M
28
Blood and lymphatic system disorders
3
Investigations
34
Coagulation abnormalities
13
Coagulation investigations
24 7
Other coagulation abnormality
90
Coagulopathy
1023
Coagulopathy
1057
C
M
29
Blood and lymphatic system disorders
3
Investigations
34
Coagulation abnormalities
13
Coagulation investigations
24 7
Thrombosis
91
Disseminated intravascular coagulation
1026
Disseminated intravascular coagulation
154
C
M
30
Blood and lymphatic system disorders
3
Investigations
34
Coagulation abnormalities
13
Coagulation investigations
24 7
Other coagulation abnormality
90
Increased coagulation time
1024
Increased coagulation time
2209
C
M
31
Blood and lymphatic system disorders
3
Investigations
34
Coagulation abnormalities
13
Coagulation investigations
24 7
Other coagulation abnormality
90
Increased coagulation time
1024
Prolonged activated partial thrombin time (APTT)
2210
C
M
Current SOC Key 1 2
Action2
C
New Term Type1
146
Current Term Type1
Aplastic anaemia
New LLT Key
86
New LLT
Aplastic anaemia
Current LLT Key
24 6
New PT Key
Bone marrow investigations
New PT Term
Current Preferred Term (PT)
212
Current PT Key
New HLT Key
Disorders of red blood cells
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 26
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 6/41
Other coagulation abnormality
90
Increased coagulation time
1024
Prolonged one stage prothrombin time (OSPT)
2211
33
Blood and lymphatic system disorders
3
Investigations
34
Coagulation abnormalities
13
Coagulation investigations
24 7
Other coagulation abnormality
90
Other coagulation abnormality NOS
1025
Other coagulation abnormality
152
34
Eye disorders
8
Investigations
34
Scleral and conjunctival disorders
64
Conjunctival investigations
25 7
Keratoconjunctivitis sicca
293
Dry eye
35
Eye disorders
8
Investigations
34
Scleral and conjunctival disorders
64
Conjunctival investigations
25 7
Keratoconjunctivitis sicca
293
Investigations
34
Conjunctival investigations
25 7
Schirmer tear test
105 1
Investigations
34
Electrolyte investigations
26 0
Acid-base disorder
337
36
37
Metabolism and nutrition disorders
1 2
12
Electrolyte and fluid balance disorders
79
Acidosis
1056
Action2
24 7
New Term Type1
Coagulation investigations
Current Term Type1
13
New LLT Key
Coagulation abnormalities
New PT Key
34
New PT Term
Investigations
New LLT
Current LLT Key
Current Low Level Term (LLT)
Current PT Key
Current Preferred Term (PT)
New HLT Key
3
New SOC Key
New HLT Term
Current HLT Key
Current High Level Term (HLT)
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 32
C
M
C
M
472
C
M
Keratoconjunctivitis sicca
471
C
M
Schirmer tear test
2666
Acidosis
1898
Other coagulation abnormality NOS
152
C
C
A
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 7/41
2075
High ionized calcium (Ca; Hypercalcemia, ionized)
1112
C
High ionized calcium (Ca; Hypercalcemia, ionized)
2684
Action2
Alkalosis
New Term Type1
1057
Current Term Type1
26 0
Alkalosis
New LLT Key
Electrolyte investigations
337
New LLT
Acid-base disorder
Current LLT Key
26 0
Current Low Level Term (LLT)
Electrolyte investigations
New PT Key
Current HLT Key 79
New PT Term
34
Electrolyte and fluid balance disorders
Current PT Key
Investigations
Current High Level Term (HLT)
New SOC Key 34
Current Preferred Term (PT)
39
Investigations
New HLT Key
12
New HLT Term
Metabolism and nutrition disorders
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 38
M
C
A
40
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
High sodiumpotassium ratio (Na:K ratio)
1058
High sodiumpotassium ratio (Na:K ratio)
2629
C
M
41
Metabolism and nutrition disorders
12
Investigations
34
Other metabolic disorders
82
Electrolyte investigations
26 0
Hypercalcaemic condition
343
Hypercalcaemia
343
Hypercalcaemia
553
C
M
42
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
Hyperchloraemia
1059
Hyperchloraemia
2577
C
M
43
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
Hyperkalaemia
1060
Hyperkalaemia
1944
C
M
1 2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 8/41
Current Low Level Term (LLT)
2511
C
M
45
Metabolism and nutrition disorders
12
Investigations
34
Other metabolic disorders
82
Electrolyte investigations
26 0
Changes in blood phosphorous
930
Hyperphosphataemia
1066
Hyperphosphataemia
2046
C
M
Investigations
34
Electrolyte investigations
26 0
Hypocalcaemia
1113
Current SOC Key
46
Hypocalcaemia
2685
C
Action2
Hypernatremia
New Term Type1
1061
Current Term Type1
Hypernatremia
New LLT Key
951
New LLT
Electrolyte disorder
Current LLT Key
26 0
New PT Key
Electrolyte investigations
New PT Term
Current Preferred Term (PT)
79
Current PT Key
New HLT Key
Electrolyte and fluid balance disorders
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
12
Current System Organ Class (SOC) Term Metabolism and nutrition disorders
Change no. 44
A
47
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
Hypochloraemia
1062
Hypochloraemia
2578
C
M
48
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
Hypokalaemia
1063
Hypokalaemia
2418
C
M
49
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
Hyponatremia
1064
Hyponatremia
2512
C
M
1 2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 9/41
51
34
Investigations
34
Other metabolic disorders
82
52
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Electrolyte disorder
951
53
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
Acid-base disorder
54
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
55
Metabolism and nutrition disorders
12
Investigations
34
Electrolyte and fluid balance disorders
79
Electrolyte investigations
26 0
1 2
Hypophosphataemia
1067
Low ionized calcium (Ca; Hypocalcaepocalcaemia, ionized) Low sodiumpotassium ratio (Na:K ratio)
1114
1065
Hypophosphataemia
2242
C
Low ionized calcium (Ca; Hypocalcaemia, ionized)
2686
Action2
New Term Type1
Current Term Type1
New LLT Key
New LLT
Current LLT Key
Current Low Level Term (LLT)
26 0
930
New PT Key
Electrolyte investigations
Changes in blood phosphorous
New PT Term
26 0
Current PT Key
Electrolyte investigations
Current Preferred Term (PT)
Current HLT Key
Current High Level Term (HLT)
New SOC Key
Investigations
New HLT Key
12
New HLT Term
Metabolism and nutrition disorders
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 50
M
C
A
Low sodiumpotassium ratio (Na:K ratio)
2630
C
M
337
Acid-base disorder
540
C
M
Electrolyte disorder
951
Cervical ventroflexion
2123
C
M
Electrolyte disorder
951
Electrolyte disorder
2144
C
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 10/41
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Hepatobiliary investigations
25 8
Hepatopathy
308
Elevated bile acids
1054
Elevated bile acids
2051
58
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Hepatobiliary investigations
25 8
Hepatopathy
308
Elevated liver enzymes
1052
Elevated ALT
2050
59
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Hepatobiliary investigations
25 8
Hepatopathy
308
Elevated liver enzymes
1052
Elevated gammaglutamyl transferase (GGT)
60
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Hepatobiliary investigations
25 8
Hepatopathy
308
Elevated liver enzymes
1052
61
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Hepatobiliary investigations
25 8
Hepatopathy
308
Elevated liver enzymes
1052
2
Action2
Current Term Type1
New LLT Key 2687
New Term Type1
Hypercalcaemic condition
57
1
New LLT
Current LLT Key
343
Current Low Level Term (LLT)
Hypercalcaemic condition
New PT Key
26 0
New PT Term
Electrolyte investigations
Current PT Key
Current Preferred Term (PT)
Current HLT Key
New HLT Key
34
New HLT Term
Investigations
Current High Level Term (HLT)
New SOC Key
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 56
C
A
C
M
C
M
2238
C
M
Elevated liver enzymes
1942
C
M
Elevated sorbitol dehydrogenase (SDH)
2525
C
M
Elevated alanine aminotransferase (ALT)
2050
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 11/41
Action2 A
63
Investigations
34
Hepatobiliary investigations
25 8
Low liver enzymes
1115
Low liver enzymes
2689
C
A
New LLT Key
C
New LLT
2688
Current LLT Key
Low alanine aminotransferase (ALT)
New PT Key 1115
New PT Term Low liver enzymes
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 25 8
Current HLT Key
Hepatobiliary investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 62
64
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Inflammatory investigations
26 8
Abnormal test result
666
Elevated Creactive protein
1096
Elevated Creactive protein
2267
C
M
65
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Inflammatory investigations
26 8
Abnormal test result
666
Elevated fibrinogen level
1097
Elevated fibrinogen level
2268
C
M
66
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Investigations NOS
25 9
Hepatopathy
308
Elevated aspartate aminotransferase (AST)
1053
Elevated AST
2049
C
M
67
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Investigations NOS
25 9
Abnormal test result
666
Elevated lactic acid dehydrogenase (LDH)
1099
Elevated lactic acid dehydrogenase (LDH)
2269
C
M
1 2
Elevated aspartate aminotransferase (AST)
2049
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 12/41
Current Low Level Term (LLT)
Current LLT Key
25 9
Abnormal test result
666
Elevated serum alkaline phosphatase (SAP)
1100
Elevated SAP
2055
69
Hepatobiliary disorders
9
Investigations
34
Hepatic disorders
66
Investigations NOS
25 9
Hepatopathy
308
Elevated total bilirubin
1055
Elevated total bilirubin
70
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Investigations NOS
25 9
Renal insufficiency
428
Increased blood urea nitrogen (BUN) or creatinine
1069
71
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Investigations NOS
25 9
Renal insufficiency
428
Increased blood urea nitrogen (BUN) or creatinine
72
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Investigations NOS
25 9
Renal insufficiency
428
73
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Investigations NOS
25 9
Renal insufficiency
428
2
2052
C
M
Azotaemia
2182
C
M
1069
Elevated BUN
2047
C
M
Increased blood urea nitrogen (BUN) or creatinine
1069
Elevated creatinine
2048
C
M
Increased blood urea nitrogen (BUN) or creatinine
1069
Elevated renal parameters
1992
C
M
Elevated blood urea nitrogen (BUN)
2047
Action2 M
Elevated serum alkaline phosphatase (SAP)
New Term Type1
C
New LLT
2055
New PT Term
Current SOC Key 1
Current Term Type1
New PT Key
Investigations NOS
New LLT Key
Current Preferred Term (PT)
154
Current PT Key
New HLT Key
General signs or symptoms
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
19
Current System Organ Class (SOC) Term Systemic disorders
Change no. 68
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 13/41
Investigations
34
General signs or symptoms
154
1101
Low serum alkaline phosphatase (SAP)
1116
Low fibrinogen level
2270
C
Low serum alkaline phosphatase (SAP)
2690
Action2
New Term Type1
Current Term Type1
New LLT Key
New LLT
25 9
Low fibrinogen level
Current LLT Key
Investigations NOS
666
Current Low Level Term (LLT)
Abnormal test result
New PT Key
25 9
New PT Term
Investigations NOS
Current PT Key
Current HLT Key
Current High Level Term (HLT)
New SOC Key 34
Current Preferred Term (PT)
75
Investigations
New HLT Key
19
New HLT Term
Systemic disorders
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 74
M
C
A
76
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Metabolic investigations
25 4
Abnormal test result
666
Decreased cholesterol (total)
1094
Decreased cholesterol (total)
2265
C
M
77
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Metabolic investigations
25 4
Abnormal test result
666
Elevated insulin
1098
Elevated insulin
2545
C
M
78
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Metabolic investigations
25 4
Abnormal test result
666
Elevated serum lipids
1095
Elevated cholesterol (total)
2266
C
M
79
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Metabolic investigations
25 4
Abnormal test result
666
Elevated serum lipids
1095
Elevated triglyceride
2508
C
M
1 2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 14/41
82
Endocrine system disorders
7
Investigations
34
Pancreas endocrine disorders
48
Metabolic investigations
25 4
Diabetes mellitus
240
83
Metabolism and nutrition disorders
12
Investigations
34
Other metabolic disorders
82
Metabolic investigations
25 4
Ketosis
84
Metabolism and nutrition disorders
12
Investigations
34
Other metabolic disorders
82
Metabolic investigations
25 4
85
Metabolism and nutrition disorders
12
Investigations
34
Other metabolic disorders
82
Metabolic investigations
25 4
1 2
2421
Elevated serum lipids
1095
Glucose intolerance
1045
C
Elevated serum lipids
2667
Action2
Lipaemia
New Term Type1
1095
Current Term Type1
25 4
Elevated serum lipids
New LLT Key
Metabolic investigations
666
New LLT
Abnormal test result
Current LLT Key
25 4
New PT Term
Metabolic investigations
Current PT Key
Current HLT Key 154
Current Low Level Term (LLT)
34
General signs or symptoms
New PT Key
Investigations
Current High Level Term (HLT)
New SOC Key 34
Current Preferred Term (PT)
81
Investigations
New HLT Key
19
New HLT Term
Systemic disorders
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 80
M
C
A
Glucose intolerance
392
C
M
351
Acetonaemia
566
C
M
Hyperglycaemia
903
Hyperglycaemia
1946
C
M
Hypoglycaemia
904
Hypoglycaemia
1947
C
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 15/41
C
M
Myoglobinuria
371
Equine myoglobinuria
604
A
M
26 1
Myoglobinuria
371
Myoglobinuria
2056
C
M
26 7
Abnormal test result
666
Abnormal test result
1221
C
M
Musculoskeletal disorders
13
Investigations
34
Muscular disorders
89
Muscle investigations
26 1
Myositis
376
88
Musculoskeletal disorders
13
Investigations
34
Muscular disorders
89
Muscle investigations
26 1
Myoglobinuria
89
Musculoskeletal disorders
13
Investigations
34
Muscular disorders
89
Muscle investigations
26 1
90
Musculoskeletal disorders
13
Investigations
34
Muscular disorders
89
Muscle investigations
91
Systemic disorders
19
Investigations
34
General signs or symptoms
154
Other abnormal test result NOS
Current SOC Key 1 2
Current HLT Key
87
New SOC Key
351
New SOC Term
Ketosis
Current System Organ Class (SOC) Term
25 4
Change no.
Metabolic investigations
Elevated creatinekinase (CK)
Other abnormal test result NOS
1068
1092
Other abnormal test result NOS
1221
Action2
605
82
New Term Type1
Azoturia
Other metabolic disorders
Current Term Type1
371
34
New LLT Key
Current LLT Key
M
Investigations
New LLT
Current Low Level Term (LLT)
C
12
New PT Key
2245
Metabolism and nutrition disorders
New PT Term
Elevated creatinekinase (CK)
Current PT Key
M
Current Preferred Term (PT)
C
New HLT Key
567
New HLT Term
Current High Level Term (HLT)
Ketosis
86
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 16/41
Current Low Level Term (LLT)
2232
C
M
93
Digestive tract disorders
5
Investigations
34
Pancreas disorders
37
Pancreatic investigations
25 2
Pancreas disorder
208
Elevated pancreatic enzymes
1040
Elevated lipase
2168
C
M
94
Investigations
34
Pancreatic investigations
25 2
Elevated pancreatic enzymes
1040
Elevated pancreatic enzymes
2661
C
A
95
Investigations
34
Pancreatic investigations
25 2
Elevated pancreatic enzymes
1040
High pancreatic-specific lipase
2692
C
A
96
Investigations
34
Pancreatic investigations
25 2
Elevated pancreatic enzymes
1040
High trypsinlike immunoreactivity (TLI)
2693
C
A
97
Investigations
34
Pancreatic investigations
25 2
Low pancreatic enzymes
1118
Low pancreatic enzymes
2694
C
A
Current SOC Key 1 2
Action2
Elevated amylase
New Term Type1
1040
Current Term Type1
Elevated pancreatic enzymes
New LLT Key
208
New LLT
Pancreas disorder
Current LLT Key
25 2
New PT Key
Pancreatic investigations
New PT Term
Current Preferred Term (PT)
37
Current PT Key
New HLT Key
Pancreas disorders
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
5
Current System Organ Class (SOC) Term Digestive tract disorders
Change no. 92
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 17/41
Action2 A
99
Investigations
34
Parathyroid investigations
25 5
Elevated parathyroid (PTH) concentration
1046
Elevated parathyroid (PTH) concentration
2664
C
A
100
Investigations
34
Parathyroid investigations
25 5
Low parathyroid (PTH) concentration
1047
Low parathyroid (PTH) concentration
2665
C
A
101
Investigations
34
Peritoneal fluid investigations
27 1
Peritoneal fluid, abnormal NOS
1124
Peritoneal fluid, high protein level
2713
C
A
102
Investigations
34
Peritoneal fluid investigations
27 1
Peritoneal fluid, abnormal NOS
1124
Peritoneal fluid, high white blood cell count
2714
C
A
103
Investigations
34
Peritoneal fluid investigations
27 1
Peritoneal fluid, abnormal NOS
1124
Peritoneal fluid, abnormal NOS
2715
C
A
1 2
New LLT Key
C
New LLT
2695
Current LLT Key
Low trypsin-like immunoreactivity (TLI)
New PT Key 1118
New PT Term Low pancreatic enzymes
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 25 2
Current HLT Key
Pancreatic investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 98
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 18/41
Action2 A
105
Investigations
34
Pleural fluid investigations
27 3
Pleural fluid, abnormal NOS
1126
Pleural fluid, high protein level
2717
C
A
106
Investigations
34
Pleural fluid investigations
27 3
Pleural fluid, abnormal NOS
1126
Pleural fluid, high red blood cell count
2718
C
A
107
Investigations
34
Pleural fluid investigations
27 3
Pleural fluid, abnormal NOS
1126
Pleural fluid, high white blood cell count
2719
C
A
108
Investigations
34
Pleural fluid investigations
27 3
Pleural fluid, abnormal NOS
1126
Pleural fluid, abnormal NOS
2720
C
A
109
Investigations
34
Red blood cell investigations
24 9
Agglutination test, positive
1119
Agglutination test, positive
2696
C
A
1 2
New LLT Key
C
New LLT
2716
Current LLT Key
High adrenocorticotropic (ACTH) hormone
New PT Key 1125
New PT Term High adrenocorticotropic (ACTH) hormone
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 27 2
Current HLT Key
Pituitary investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 104
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
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Action2 A
111
Investigations
34
Red blood cell investigations
24 9
Agglutination test, positive
1119
Saline slide agglutination test, positive
2698
C
A
New LLT Key
C
New LLT
2697
Current LLT Key
Direct Coombs test, positive
New PT Key 1119
New PT Term Agglutination test, positive
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 24 9
Current HLT Key
Red blood cell investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 110
112
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Reticulocyte disorders
966
Decreased percentage of reticulocytes
1029
Decreased percentage of reticulocytes
2212
C
M
113
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Reticulocyte disorders
966
Increased percentage reticulocytes
1030
Increased percentage reticulocytes
2213
C
M
114
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Disorder of red blood cell NOS
745
Polycythaemia
1028
Increased packed cell volume (PCV)
2419
C
M
115
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Red blood cell investigations
24 9
Increased red blood cell count
101 8
Polycythaemia
1028
Increased red blood cell count
2613
C
M
1 2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 20/41
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Disorder of red blood cell NOS
118
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
119
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
120
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
121
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Current SOC Key 1 2
Action2
Investigations
New Term Type1
3
Current Term Type1
Blood and lymphatic system disorders
1028
New LLT Key
117
Polycythaemia
New LLT
745
Current LLT Key
Disorder of red blood cell NOS
Current Low Level Term (LLT)
24 9
New PT Key
Red blood cell investigations
New PT Term
Current Preferred Term (PT)
212
Current PT Key
New HLT Key
Disorders of red blood cells
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 116
Polycythaemia
2521
C
M
745
Abnormal red blood cell
2217
C
M
Anaemia NOS
85
Anaemia NOS
142
C
M
24 9
Anaemia NOS
85
Decreased haemoglobin
2214
C
M
Red blood cell investigations
24 9
Anaemia NOS
85
Decreased packed cell volume (PCV)
2215
C
M
Red blood cell investigations
24 9
Anaemia NOS
85
Decreased red blood cell count
2157
C
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 21/41
Current Low Level Term (LLT)
M
123
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Anaemia NOS
85
Haemolysis
2156
C
M
124
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Haemolytic anaemia
87
Haemolytic anaemia
147
C
M
125
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Anaemia NOS
85
Heinz body anaemia
2216
C
M
126
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Anaemia NOS
85
Iron deficiency anaemia
144
C
M
127
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Methaemoglobinaemia
967
Methaemoglobinaemia
2218
C
M
Current SOC Key 1 2
Action2
C
New Term Type1
1416
Current Term Type1
Disorder of red blood cell NOS
New LLT Key
745
New LLT
Disorder of red blood cell NOS
Current LLT Key
24 9
New PT Key
Red blood cell investigations
New PT Term
Current Preferred Term (PT)
212
Current PT Key
New HLT Key
Disorders of red blood cells
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 122
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 22/41
Current Low Level Term (LLT)
C
M
129
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Disorder of red blood cell NOS
745
Red blood cell disorder
181
C
M
130
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Regenerative anaemia
624
Regenerative anaemia
1056
C
M
131
Blood and lymphatic system disorders
3
Investigations
34
Disorders of red blood cells
212
Red blood cell investigations
24 9
Disorder of red blood cell NOS
745
Spherocytosis
2612
C
M
132
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Acidic urine
1074
Acidic urine
1951
C
M
133
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Alkaline urine
1075
Alkaline urine
1952
C
M
Current SOC Key 1 2
Action2
145
New Term Type1
Nonregenerative anaemia
Current Term Type1
85
New LLT Key
Anaemia NOS
New LLT
24 9
Current LLT Key
Current PT Key
Red blood cell investigations
New PT Key
Current Preferred Term (PT)
212
New PT Term
New HLT Key
Disorders of red blood cells
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 128
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 23/41
26 2
Decreased blood urea nitrogen (BUN) or creatinine
1120
Low blood urea nitrogen (BUN)
2700
C
A
Renal and urinary investigations
26 2
Decreased blood urea nitrogen (BUN) or creatinine
1120
Low creatinine
2701
C
A
Renal and urinary investigations
26 2
Decreased blood urea nitrogen (BUN) or creatinine
1120
Decreased blood urea nitrogen (BUN) or creatinine
2702
C
A
Investigations
34
137
New HLT Term
34
136
Current HLT Key
Investigations
New SOC Key
Renal and urinary investigations
Investigations
C
Action2
Current LLT Key 2175
34
135
110
New Term Type1
Current Low Level Term (LLT) Bilirubinuria
Urine abnormalities
Urinary tract disorders
Current Term Type1
New PT Key 1076
26 2
34
New LLT Key
New PT Term Bilirubinuria
Renal and urinary investigations
Investigations
New LLT
Current PT Key
Current High Level Term (HLT)
906
Current Preferred Term (PT)
15
New HLT Key
Renal and urinary disorders
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 134
M
138
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Decreased urine concentration
1078
Decreased urine concentration
1963
C
M
139
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Decreased urine concentration
1078
Hyposthenuria
2475
C
M
1 2
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 24/41
2533
141
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Renal and urinary investigations
26 2
Renal insufficiency
428
Elevated symmetrical dimethylarginine (SDMA)
1071
Elevated SDMA (Symmetrical dimethylarginine)
2583
142
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Glucosuria
1079
Glucosuria
143
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Haematuria
1077
144
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Haematuria
145
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Haemoglobinuria
Current SOC Key 1 2
Action2
Elevated protein:creatini ne ratio
New Term Type1
1070
Current Term Type1
Elevated protein:creatini ne ratio
New LLT Key
428
New LLT
Renal insufficiency
Current LLT Key
26 2
Current Low Level Term (LLT)
Current Preferred Term (PT)
Renal and urinary investigations
New PT Key
New HLT Key
107
New PT Term
Current HLT Key
Renal disorders
Current PT Key
Current High Level Term (HLT)
34
New HLT Term
New SOC Key
Investigations
New SOC Term
15
Current System Organ Class (SOC) Term Renal and urinary disorders
Change no. 140
C
M
C
M
1960
C
M
Blood in urine
1956
C
M
1077
Haematuria
1967
C
M
1081
Haemoglobinuria
2027
C
M
Elevated symmetrical dimethylarginine (SDMA)
2583
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 25/41
Current Low Level Term (LLT)
C
M
147
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Increased urine concentration
1082
Increased urine concentration
1962
C
M
148
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Renal and urinary investigations
26 2
Renal insufficiency
428
Isosthenuria
1072
Isosthenuria
2254
C
M
149
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Proteinuria
1083
Proteinuria
1961
C
M
150
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Pyuria
1084
Pyuria
2255
C
M
151
Renal and urinary disorders
15
Investigations
34
Renal disorders
107
Renal and urinary investigations
26 2
Renal insufficiency
428
Uraemia
1073
Uraemia
722
C
M
Current SOC Key 1 2
Action2
2477
New Term Type1
Hypersthenuria
Current Term Type1
1082
New LLT Key
Increased urine concentration
New LLT
906
Current LLT Key
Urine abnormalities
New PT Key
26 2
New PT Term
Renal and urinary investigations
Current PT Key
Current Preferred Term (PT)
110
New HLT Term
Urinary tract disorders
Current HLT Key
New HLT Key
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
15
Current System Organ Class (SOC) Term Renal and urinary disorders
Change no. 146
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 26/41
Current Low Level Term (LLT)
C
M
153
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Urine abnormalities NOS
907
Abnormal urine odour
1966
C
M
154
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urine abnormalities
906
Urine abnormalities NOS
907
Discoloured urine
1964
C
M
155
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urolithiasis
440
Calculi
741
C
M
156
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urolithiasis
440
Crystalluria
2028
C
M
157
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urolithiasis
440
NT - pelvic lithiasis
2374
C
M
Current SOC Key 1 2
Action2
2256
New Term Type1
Uric acid crystals
Current Term Type1
1087
New LLT Key
Uric acid crystals
New LLT
440
Current LLT Key
Urolithiasis
New PT Key
26 2
New PT Term
Current PT Key
Renal and urinary investigations
New HLT Key
110
New HLT Term
Urinary tract disorders
Current HLT Key
Current Preferred Term (PT)
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
15
Current System Organ Class (SOC) Term Renal and urinary disorders
Change no. 152
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 27/41
Current Low Level Term (LLT)
159
Renal and urinary disorders
15
Investigations
34
Urinary tract disorders
110
Renal and urinary investigations
26 2
Urolithiasis
440
Urolithiasis
740
C
M
Investigations
34
Renal and urinary investigations
26 2
Urine abnormalities NOS
907
Current SOC Key
160
161
Reproductive system disorders
16
Investigations
34
Fertility disorders
118
Reproductive investigations
26 3
Abnormal spermatozoa
451
Abnormal spermatozoa NOS
451
Abnormal spermatozoa
763
162
Reproductive system disorders
16
Investigations
34
Fertility disorders
118
Reproductive investigations
26 3
Abnormal spermatozoa
451
Abnormal spermatozoa NOS
451
Decreased spermatozoa motility
163
Reproductive system disorders
16
Investigations
34
Fertility disorders
118
Reproductive investigations
26 3
Abnormal spermatozoa
451
Decreased number of spermatozoa
1088
Decreased number of spermatozoa
1 2
Active urine sediment
2699
Abnormal spermatozoa NOS
763
C
Action2 M
New Term Type1
C
Current Term Type1
1959
New LLT Key
Urine abnormalities NOS
New LLT
907
Current LLT Key
Urine abnormalities NOS
New PT Key
26 2
New PT Term
Renal and urinary investigations
Current PT Key
Current Preferred Term (PT)
110
New HLT Term
Urinary tract disorders
Current HLT Key
New HLT Key
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
15
Current System Organ Class (SOC) Term Renal and urinary disorders
Change no. 158
A
C
M
2128
C
M
2129
C
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 28/41
34
Residues
235
Residue investigations
26 9
Residues
929
Residues in eggs
166
Systemic disorders
19
Investigations
34
Residues
235
Residue investigations
26 9
Residues
929
167
Systemic disorders
19
Investigations
34
Residues
235
Residue investigations
26 9
Residues
168
Systemic disorders
19
Investigations
34
Residues
235
Residue investigations
26 9
169
Systemic disorders
19
Investigations
34
Residues
235
Residue investigations
26 9
Current SOC Key 1 2
Action2
Investigations
New Term Type1
19
Current Term Type1
Systemic disorders
New LLT Key
165
New LLT
954
Current LLT Key
High oestrogen level
Current Low Level Term (LLT)
26 3
New PT Key
Reproductive investigations
New PT Term
Current Preferred Term (PT)
119
Current PT Key
New HLT Key
Gonadotrophin and sex hormone changes
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
16
Current System Organ Class (SOC) Term Reproductive system disorders
Change no. 164
High oestrogen level
2132
C
M
1102
Residues in eggs
2040
A
M
Residues in honey
1103
Residues in honey
2041
A
M
929
Residues in meat/offal
1104
Residues in meat/offal
2042
A
M
Residues
929
Residues in milk
1105
Residues in milk
2043
A
M
Residues
929
Residues NOS
1106
Residues NOS
2044
A
M
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 29/41
Current Low Level Term (LLT)
Change in blood protein
909
Abnormal serum protein NOS
1032
Change in blood protein NOS
2220
171
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
Elevated globulins
1033
Elevated globulins
172
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
Hyperalbuminaemia
1034
173
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
Hyperproteinaemia
174
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
175
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
2
M
Hyperalbuminaemia
2154
C
M
1035
Hyperproteinaemia
2155
C
M
Hypoalbuminaemia
1036
Hypoalbuminaemia
1883
C
M
Hypoproteinaemia
1037
Hypoproteinaemia
1976
C
M
Action2
C
Abnormal serum protein NOS
New Term Type1
2556
New LLT
M
Current LLT Key
C
New PT Key
2220
New PT Term
Current SOC Key 1
Current Term Type1
25 1
New LLT Key
Serum protein investigations
Current PT Key
Current Preferred Term (PT)
19
New HLT Term
Other blood disorders
Current HLT Key
New HLT Key
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 170
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 30/41
Current Low Level Term (LLT)
C
M
177
Blood and lymphatic system disorders
3
Investigations
34
Other blood disorders
19
Serum protein investigations
25 1
Change in blood protein
909
Reduced globulins
1039
Reduced globulins
2557
C
M
178
Investigations
34
Synovial fluid investigations
27 4
Synovial fluid, abnormal NOS
1127
Synovial fluid, abnormal NOS
2721
C
A
179
Investigations
34
Synovial fluid investigations
27 4
Synovial fluid, high protein level
1128
Synovial fluid, high protein level
2722
C
A
180
Investigations
34
Synovial fluid investigations
27 4
Synovial fluid, high red blood cell count
1129
Synovial fluid, high red blood cell count
2723
C
A
181
Investigations
34
Synovial fluid investigations
27 4
Synovial fluid, high white blood cell count
1130
Synovial fluid, high white blood cell count
2724
C
A
Current SOC Key 1 2
Action2
2117
New Term Type1
Inversion of albumin/globulin ratio
Current Term Type1
1038
New LLT Key
Inversion of albumin/globulin ratio
New LLT
909
Current LLT Key
Change in blood protein
New PT Key
25 1
New PT Term
Serum protein investigations
Current PT Key
Current Preferred Term (PT)
19
New HLT Term
Other blood disorders
Current HLT Key
New HLT Key
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 176
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 31/41
Current Low Level Term (LLT)
2424
C
M
183
Blood and lymphatic system disorders
3
Investigations
34
Disorders of platelets and coagulopathies
15
Thrombocyte investigations
24 8
Platelet disorder NOS
985
Large platelets
1027
Large platelets
2425
C
M
184
Blood and lymphatic system disorders
3
Investigations
34
Disorders of platelets and coagulopathies
15
Thrombocyte investigations
24 8
Thrombocytopenia
95
Low platelet count
161
C
M
185
Blood and lymphatic system disorders
3
Investigations
34
Disorders of platelets and coagulopathies
15
Thrombocyte investigations
24 8
Platelet disorder NOS
985
Platelet disorder NOS
2423
C
M
186
Blood and lymphatic system disorders
3
Investigations
34
Disorders of platelets and coagulopathies
15
Thrombocyte investigations
24 8
Thrombocytopenia
95
Thrombocytopenia
160
C
M
187
Blood and lymphatic system disorders
3
Investigations
34
Disorders of platelets and coagulopathies
15
Thrombocyte investigations
24 8
Thrombocytosis
949
Thrombocytosis
2116
C
M
Current SOC Key 1 2
Action2
Giant platelets
New Term Type1
1027
Current Term Type1
Large platelets
New LLT Key
985
New LLT
Platelet disorder NOS
Current LLT Key
24 8
New PT Key
Thrombocyte investigations
New PT Term
Current Preferred Term (PT)
15
Current PT Key
New HLT Key
Disorders of platelets and coagulopathies
Current HLT Key
New HLT Term
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 182
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 32/41
Action2 A
189
Investigations
34
Thyroid investigations
25 6
Abnormal thyroidrelated autoantibodies
1121
Abnormal thyroglobulin autoantibodies (TgAA)
2706
C
A
190
Investigations
34
Thyroid investigations
25 6
Abnormal thyroidrelated autoantibodies
1121
Abnormal triiodothyronine autoantibodies (T3AA)
2707
C
A
191
Investigations
34
Thyroid investigations
25 6
Abnormal thyroidrelated autoantibodies
1121
Abnormal thyroxine autoantibodies (T4AA)
2708
C
A
192
Investigations
34
Thyroid investigations
25 6
Elevated T4 (thyroxine)
1048
Elevated T4 (thyroxine)
2669
C
A
193
Investigations
34
Thyroid investigations
25 6
High triiodothyronine (T3)
1122
High free triiodothyronine (FT3)
2709
C
A
1 2
New LLT Key
C
New LLT
2668
Current LLT Key
Abnormal thyroid stimulating hormone (TSH) level
New PT Key 1049
New PT Term Abnormal thyroid stimulating hormone (TSH)
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 25 6
Current HLT Key
Thyroid investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 188
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 33/41
Action2 A
195
Investigations
34
Thyroid investigations
25 6
Low T4 (thyroxine)
1050
Low thyroxine (T4 )
2670
C
A
196
Investigations
34
Thyroid investigations
25 6
Low triiodothyronine (T3)
1123
Low free triiodothyronine (FT3)
2711
C
A
197
Investigations
34
Thyroid investigations
25 6
Low triiodothyronine (T3)
1123
Low triiodothyronine (T3)
2712
C
A
198
Investigations
34
Thyroid investigations
25 6
Abnormal thyroid stimulating hormone (TSH)
104 9
High thyroid stimulating hormone (TSH)
2703
C
A
199
Investigations
34
Thyroid investigations
25 6
High thyroxine (T4)
104 8
High free thyroxine (FT4)
2704
C
A
1 2
New LLT Key
C
New LLT
2710
Current LLT Key
High triiodothyronine (T3)
New PT Key 1122
New PT Term High triiodothyronine (T3)
Current PT Key
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
New HLT Key 25 6
Current HLT Key
Thyroid investigations
New SOC Key 34
New SOC Term
New HLT Term
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term
Investigations
Change no. 194
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 34/41
201
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Leucocytosis
97
Leucocytosis NOS
97
Leucocytosis
163
202
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Leucocytosis
97
Monocytosis
1031
Monocytosis
203
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Basophilia
968
204
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Eosinophilia
205
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Leucopenia
1 2
Leucocytosis NOS
163
Action2
2705
New Term Type1
Low free thyroxine (FT4)
Current Term Type1
New LLT Key
New LLT
105 0
Current LLT Key
Low thyroxine (T4)
Current Low Level Term (LLT)
25 6
New PT Key
Current PT Key
Thyroid investigations
New PT Term
Current Preferred Term (PT)
Current HLT Key
New HLT Key
34
New HLT Term
Investigations
Current High Level Term (HLT)
New SOC Key
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 200
C
A
C
M
2420
C
M
Basophilia
2219
C
M
96
Eosinophilia
162
C
M
98
Leucopenia
164
C
M
Leucopenia NOS
164
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 35/41
Current Low Level Term (LLT)
207
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Lymphopenia
100
Lymphopenia
166
C
M
208
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Neutropenia
101
Neutropenia
167
C
M
209
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Neutrophilia
102
Neutrophilia
168
C
M
210
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Panleucopenia
103
Panleucopenia
169
C
M
211
Blood and lymphatic system disorders
3
Investigations
34
Disorders of white blood cells
16
White blood cell investigations
25 0
Stress leukogram
101 2
Stress leukogram
2589
C
M
Current SOC Key 1 2
Action2 M
New Term Type1
C
Current Term Type1
165
New LLT Key
Lymphocytosis
New LLT
99
Current LLT Key
Lymphocytosis
New PT Key
25 0
New PT Term
Current PT Key
White blood cell investigations
New HLT Key
16
New HLT Term
Disorders of white blood cells
Current HLT Key
Current Preferred Term (PT)
Current High Level Term (HLT)
34
New SOC Key
Investigations
New SOC Term
3
Current System Organ Class (SOC) Term Blood and lymphatic system disorders
Change no. 206
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 36/41
Action2
Musculoskeletal disorders
13
Musculoskeletal disorders
90
Lameness
378
Hip dysplasia
2725
C
A
214
Musculoskeletal disorders
13
Musculoskeletal disorders
90
Musculoskeletal disorder NOS
640
Difficulty to rise
2726
C
A
215
Neurological disorders
14
Convulsions and epilepsy
97
Epileptic seizure
398
Grand mal seizure
2727
C
A
216
Neurological disorders
14
Neurological disorders NOS
219
Neurological disorder NOS
812
Neurological disorder NOS
2728
C
A
217
Neurological disorders
14
Peripheral neuropathies and neuritis
103
Peripheral nerve injury
831
Peripheral nerve injury
2747
C
A
1 2
New LLT Key
213
New LLT
A
Current LLT Key
C
New PT Key
2745
New PT Term
Lactation change NOS
Current PT Key 950
New HLT Key
Lactation change
New HLT Term
76
Current HLT Key
Milk production disorders
New SOC Key
11
New SOC Term
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term Mammary gland disorders
Change no. 212
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
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Action2
New Term Type1
Current Term Type1
New LLT Key
New LLT
Current LLT Key
Current Low Level Term (LLT)
New PT Key
New PT Term
Current PT Key
Current Preferred Term (PT)
New HLT Key
New HLT Term
Current HLT Key
Current High Level Term (HLT)
New SOC Key
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no. 218
Renal and urinary disorders
15
Urinary tract disorders
110
Urine abnormalities
906
Urinary tract bleeding
1085
Urinary tract bleeding
1965
C
M
219
Renal and urinary disorders
15
Urinary tract disorders
110
Urine abnormalities
906
Urinary tract infection
1086
Urinary tract infection
2026
C
M
220
Respiratory tract disorders
17
Bronchial and lung disorders
132
Atelectasis
991
221
Skin and appendages disorders
18
Skin and appendages neoplasms
146
222
Skin and appendages disorders
18
Skin and subcutaneous tissue disorders
238
Skin haemorrhage
223
Skin and appendages disorders
18
Sweating disorders
149
Miliaria
1 2
Atelectasis
2749
C
A
Mast cell tumour
2729
C
A
848
Skin haemorrhage NOS
2748
C
A
553
Miliaria
2746
C
A
Mast cell tumour
1131
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 38/41
Action2
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Bee brood death
2731
A
A
226
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Bee brood mortality
2732
A
A
227
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Bee colony death
2733
A
A
228
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Bee wing deformation
2734
A
A
229
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Hive weakness
2735
A
A
1 2
New LLT Key
225
New LLT
A
Current LLT Key
A
New PT Key
2730
New PT Term
Decreased egglaying (bees)
Current PT Key 960
New HLT Key
Bee systemic disorder NOS
New HLT Term
241
Current HLT Key
Bee systemic disorders
New SOC Key
19
New SOC Term
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term Systemic disorders
Change no. 224
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 39/41
Action2
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Queen bee death
2737
A
A
232
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Queen bee loss
2738
A
A
233
Systemic disorders
19
Bee systemic disorders
241
Bee systemic disorder NOS
960
Queen bee rejection
2739
A
A
234
Systemic disorders
19
General signs or symptoms
154
Abnormal test result
666
235
Systemic disorders
19
General signs or symptoms
154
Anorexia
598
1 2
Sick euthyroid syndrome
1117
Sick euthyroid syndrome
New LLT Key
231
New LLT
A
Current LLT Key
A
New PT Key
2736
New PT Term
Loss of egg quantity (bees)
Current PT Key 960
New HLT Key
Bee systemic disorder NOS
New HLT Term
241
Current HLT Key
Bee systemic disorders
New SOC Key
19
New SOC Term
New Term Type1
Current Term Type1
Current Low Level Term (LLT)
Current Preferred Term (PT)
Current High Level Term (HLT)
Current SOC Key
Current System Organ Class (SOC) Term Systemic disorders
Change no. 230
2507
C
Off food
2740
M
C
A
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 40/41
New Term Type1
Action2
Increased skin temperature
2691
C
A
1132
Cold feeling to the touch
2741
C
A
Low skin temperature
1132
Low skin temperature
2744
C
A
Lying down
1134
Lying down
2743
C
A
19
General signs or symptoms
154
237
Systemic disorders
19
General signs or symptoms
154
Increased skin temperature
1133
Warm feeling to the touch
238
Systemic disorders
19
General signs or symptoms
154
Increased skin temperature
1133
239
Systemic disorders
19
General signs or symptoms
154
Low skin temperature
240
Systemic disorders
19
General signs or symptoms
154
241
Systemic disorders
19
General signs or symptoms
154
2
New LLT Key
A
Discomfort NOS
New LLT
C
994
Current LLT Key
Current Term Type1
Current Low Level Term (LLT)
2742
New PT Key
M
New PT Term
Current PT Key
Current Preferred Term (PT)
New HLT Key
New HLT Term
Current HLT Key
Current High Level Term (HLT)
New SOC Key
New SOC Term
Current SOC Key
Current System Organ Class (SOC) Term
Change no.
C
Systemic disorders
1
Discomfort NOS
A
236
2498
: A: animal; C: common; H: human : A: addition; D: deletion; M: modification
List of changes to combined VeDDRA list of clinical terms EMA/CVMP/PhVWP/272687/2018
Page 41/41
