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Case Definitions for AE_ID

HICDEP Code ICD-10 codes Adverse Event Definition
AMI I21.9 Acute myocardial infarction Definitive myocardial infarction (MI)
i) definitive electrocardiogram (ECG),
ii) symptoms together with probable ECG and abnormal enzymes,
iii) typical symptoms, abnormal enzymes and ischaemic/non-codable/not available ECG, or
iv) fatal cases with naked-eye appearance of fresh MI and/or recent coronary occlusion found at necropsy.
Please see the MONICA manual for further criteria.
STR I64.9 Stroke, not specified as haemorrhage or infarction Rapidly developed clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours (unless interrupted by surgery or death), with no apparent cause other than a cardiovascular origin. Secondary stroke caused by trauma should be excluded.
The differentiation between infarction and haemorrhage should be based on results of cerebral scanning or necropsy. In case of uncertainty (results not interpretable, or test not performed), please indicate so on the event form.
Please see the MONICA manual and the DAD MOOP (Manual of Operations) for further criteria.
DIA E14 (also E10 – insulin dependent and E11 non-insulin-dependent) Unspecified diabetes mellitus The diagnostic criteria is: fasting blood glucose > 7 mmol/l
Please see the ADA (the American Diabetes Association) criteria for classification.
ICP - BYP n/a Coronary artery by-pass grafting Procedure
ICP - END n/a Carotic endarterectomy Procedure
ICP - ANG n/a Coronary angioplasty/stenting Procedure
LAC Lactate acidosis Elevated S-lactate > 2.5 mM (>22.3 mg/dL) AND plasma pH < 7.35 (alternatively: Bicarbonate/HCO3<= 20 mM (<= 20 meq/L)) AND otherwise unexplained recent onset of at least one of the following: Abdominal distension, anorexia, abdominal pain, nausea, vomiting, diarrhea, increased liver function enzymes, jaundice, dyspnea, fever, neuropathy, generalized weakness, ascending neuromuscular weakness, myalgias, paresthesias, weight loss or hepatomegaly.
PAN Pancreatitis Typical clinical history (i.e. severe abdominal pain), plus one or more of the following: elevated serum amylase > 1.5x ULN, elevated serum lipase, radiological findings.
ESRD N18.0 (N18.8/9, N25.9, N26, N0.5, N04, N08) End stage renal disease A. Hemodialysis or peritoneal dialysis expected to last at least three months, documented in a clinical note
B. A kidney transplant, documented in a clinical note
Confirmed: A or B
Probable: Not applicable
AVN Avascular necrosis in the femural head Diagnosed by the combination of clinical symptoms (pain, walking difficulties) and imaging findings (MRI, bone scintigraphy)
FRA Several depending on location Bone fracture Diagnosed by X-ray
HEP Severe hepatic encephalopathy (stage III or IV) Stage III: marked confusion, incoherent speech, asterixis, sleeping but arousable - Stage IV: coma
CLD Chronic liver disease –severe clinical manifestations A. 1. Clinical symptoms of end-stage liver failure in patients with chronic liver disease, based on the diagnosis documented in a clinical note of either
(i) bleeding from gastric or esophageal varices
(ii) hepatic encephalopathy stage III or IV
(iii) hepatorenal syndrome
A. 2 liver transplantation documented in a clinical note
B. Pathology report or fibro-scan report documenting severe liver fibrosis or cirrhosis (Metavir F3 or F4 or fibroscan liver stiffness >= 8 kPa)
Confirmed: A1 and B; or A2
Probable: A1
NADM Non AIDS defining cancers A.Diagnosis of cancer (other than: AIDS defining (non-Hodgkin’s lymphoma, Kaposi's sarcoma ), or invasive cervical cancer); and basal and squamous cell skin cancers) in a pathology report that established the diagnosis
B. Diagnosis of cancer (other than: AIDS defining (non-Hodgkin’s lymphoma, Kaposi's sarcoma, or invasive cervical cancer); and basal and squamous cell skin cancers) in a hospital discharge summary or consultation note from the hospitalization or clinic visit during which the diagnosis was established
C. In the absence of A or B: Strong suspicion of cancer supported by (i) evidence from radiological or other imaging technique, (ii) or biochemical assay
D. In the absence of A, B or C: Strong suspicion of cancer by visual inspection (e.g. skin metastasis, suspected malignant melanoma, tissue growth resembling cancer visualized during endoscopy/anoscopy) not explained by other known conditions.
Confirmed: A or B
Probable: C
Possible: D
* The date of diagnosis is the month, day and year the tumor was first diagnosed by a recognized medical practitioner, whether clinically or microscopically confirmed.