REGISTRY OF SEVERE CUTANEOUS ADVERSE REACTIONS TO DRUGS AND COLLECTION OF BIOLOGICAL SAMPLES. R e g i S C A R PATIENT'S DATA. Age country of birth

Transcription

1 REGISTRY OF SEVERE CUTANEOUS ADVERSE REACTIONS TO DRUGS AND COLLECTION OF BIOLOGICAL SAMPLES R e g i S C A R PATIENT'S DATA Initials of the patient date of birth Age country of birth Gender male female Death before interview no Participation agreed to by the patient registry yes cohort study (only for DRESS) genetic study

2 - 2 - HOSPITAL DATA Reporting hospital / department hospital no. date of admission Treating hospital / department hospital no. date of admission date of notification date of interview Transfer from one or more hospitals to the reporting / treating hospital: no yes unknown If yes, first hospital: hospital no. date of admission Retrospective assessment no yes Development of skin reaction prior to admission during inhospital stay

3 - 3 - DIAGNOSES AND CLINICAL COURSE Admission diagnoses 1) 2) 3) Date Clinical symptoms Fever If yes, date of onset date of normalization* highest temperature ( C) method of measurement * if cured before admission

4 - 4 C - SKIN SYMPTOMS Burning FOR CASES OF DRESS ONLY date of onset date of normalization* Pain Pruritus Exanthema If yes, - maculopapular / morbilliform - urticarial - confluent erythema - exfoliative dermatitis - other: (please specify) Specific lesions If yes, - edematous erythema - target-like lesions - pustules - purpura - infiltrated plaques - eczema-like lesions date of onset date of normalization* Blisters / erosions date of onset Nikolski s skin Facial edema Maximum of erythema (percentage related to the BSA) Maximum of detachment (percentage related to the BSA if blisters/ erosions were seen) date of maximum Resolution of erythema/ Specific lesions 8 15 days * if cured before admission

5 - 5 C - FOR CASES OF DRESS ONLY MUCOSAL SYMPTOMS If yes, please specify date of onset date of resolution* * if cured before admission

6 - 6 C1 FOR CASES OF DRESS ONLY ORGAN INVOLVEMENT 1 LIVER If yes, please specify date of diagnosis - Jaundice date of onset Is there a suspicion of excessive alcohol intake? If yes, chronic acute KIDNEY If yes, please specify date of diagnosis LUNG If yes, please specify date of diagnosis DYSPNEA date of onset

7 - 6 C2 - FOR CASES OF DRESS ONLY ORGAN INVOLVEMENT 2 HEART / MUSCLES If yes, please specify date of diagnosis GI-TRACT If yes, please specify date of diagnosis PALPABLE LYMPH NODES (>1cm, at least two sites) date of diagnosis NEUROLOGICAL SYSTEM - Headache date of onset - Paresis - other If yes, please specify date of diagnosis SORE THROAT date of onset OTHER ORGAN INVOLVEMENT If yes, please specify If yes, please specify date of diagnosis date of diagnosis

8 - 6 D1 FOR CASES OF DRESS ONLY MEDICAL IMAGING AND BIOPSIES 1 Have the following investigations been done? - X-ray chest date of performance If yes, normal abnormal please specify - Chest-CT date of performance If yes, normal abnormal please specify - Bronchial endoscopy date of performance If yes, normal abnormal please specify - ECG date of performance If yes, normal abnormal please specify - Echocardiogram date of performance If yes, normal abnormal please specify - Abdominal sonography date of performance If yes, normal abnormal please specify

9 - 6 D2 FOR CASES OF DRESS ONLY MEDICAL IMAGING AND BIOPSIES 2 Have the following investigations been done? - Gastrointest. endoscopy date of performance If yes, normal abnormal please specify - Other imaging (CT/MRI) date of performance If yes, normal abnormal please specify If yes, normal abnormal please specify - Liver biopsy date of performance If yes, normal abnormal please specify - Kidney biopsy date of performance If yes, normal abnormal please specify - Biopsy of other organ date of performance If yes, normal abnormal please specify - Puncture of other organ date of performance If yes, normal abnormal please specify

10 - 6 E1a FOR CASES OF DRESS ONLY BLOOD CELL COUNT - VALUES - Date of sampling: Laboratory number: (ascending number for each lab or if ranges/units are updated) Leucocytes Value (numerical) Neutrophils Eosinophils Basophils Lymphocytes Atyp. Lymphocytes Monocytes Platelets HB Quick PTT Other 1.: Other 2.: Other 3.: Other 4.: Other 5.:

11 - 6 E2a FOR CASES OF DRESS ONLY CLINIAL CHEMISTRY - VALUES - Date of sampling: Laboratory number: (ascending number for each lab or if ranges/units are updated) ALAT ASAT GGT AP LDH Bilirubin Lipase Amylase Creatinine Creatinine clearance Urea Proteinuria Hematuria Leucocyturia CK CK-MB Troponin CRP PH Value (numerical) PO 2 PCO 2 HCO 3 SaO 2 Base excess Other 1.: Other 2.: Other 3.: Other 4.: Other 5.:

12 - 6 E1b FOR CASES OF DRESS ONLY BLOOD CELL COUNT - REFERENCE RANGES AND UNITS - Laboratory number: (ascending number for each lab or if ranges/units are updated) Leucocytes Lower limit (numerical) Upper limit (numerical) Unit (text) Neutrophils Eosinophils Basophils Lymphocytes Atyp. Lymphocytes Monocytes Platelets HB Quick PTT Other 1.: Other 2.: Other 3.: Other 4.: Other 5.:

13 - 6 E2b FOR CASES OF DRESS ONLY CLINIAL CHEMISTRY - REFERENCE RANGES AND UNITS - Laboratory number: (ascending number for each lab or if ranges/units are updated) ALAT ASAT GGT AP LDH Bilirubin Lipase Amylase Creatinine Creatinine clearance Urea Proteinuria Hematuria Leucocyturia CK CK-MB Troponin CRP PH PO 2 PCO 2 HCO 3 SaO 2 Base excess Other 1.: Other 2.: Other 3.: Other 4.: Other 5.: Lower limit (numerical) Upper limit (numerical) Unit (text)

14 - 6 E3a FOR CASES OF DRESS ONLY LABORATORY VALUES 1 Have the following laboratory examinations been done? n y u If yes, please specify: Date of sampling Comments (result, method, titer, etc.) Blood culture 1 2 Chlamydia 1 n y u If yes, please specify: Date of sampling Suggesting recent infection/ reactivation Comments (result, method, titer, etc.) 2 Mycoplasma 1 2 Other 1.: Other 2.: Other 3.: Other 4.: Other 5.: Other laboratory examinations If yes, please specify: Date of sampling Suggesting recent infection/ reactivation Comments (result, method, titer, etc.)

15 - 6 E3b FOR CASES OF DRESS ONLY LABORATORY VALUES 2 Have the following laboratory examinations been done? HAV 1 n y u If yes, please specify: Date of sampling Suggesting recent infection/ reactivation Comments (result, method, titer, etc.) 2 HBV 1 2 HCV 1 2 EBV 1 2 CMV 1 2 HHV6 1 2 Parvovirus B ANA 1 Other 1.: Other 2.: Other 3.: Other 4.: Other 5.: Other laboratory examinations If yes, please specify: Date of sampling Suggesting recent infection/ reactivation Comments (result, method, titer, etc.)

16 - 7 - FOR ALL CASES FURTHER INFORMATION FOR CASE VALIDATION Photographs date of first occurrence Biopsy Diagnosis by a dermatologist If yes, please specify: Further photographs / biopsies and comments: Date Notes

17 - 8 - SYMPTOMS / EVENTS WITHIN 1 MONTH BEFORE THE RECENT SKIN REACTION Herpes labialis or fever blisters date of onset date of normalization* Do you have recurrent herpes labialis or fever blisters? date of last eruption Herpes genitalis date of onset date of normalization* Do you have recurrent genital herpes? date of last eruption *if cured before admission

18 - 9 - SYMPTOMS / EVENTS WITHIN 1 MONTH BEFORE THE RECENT SKIN REACTION Infections If yes, - influenza / influenza-like illness date of onset date of normalization* Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? - respiratory tract infection Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? - urinary tract infection Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? - other infection 1 (please specify) Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? - other infection 2 (please specify) *if cured before admission Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? HIV-status HIV AIDS (current status) If yes for HIV or AIDS, most recent CD4 count per Ll: *if cured before admission

19 HAVE YOU HAD ANY OF THE FOLLOWING DISEASES THAT ARE STILL ACTIVE? Severe liver disorders year of event If yes, (please specify) Severe kidney disorders year of event If yes, (please specify) Rheumatic / collagen-vascular disease If yes, - rheumatoid polyarthritis year of event - systemic lupus erythematosus - other: If yes, (please specify) Was a first-degree family member diagnosed with any rheumatic/ collagen-vascular disease? Inflammatory bowel disease - Colitis ulcerosa year of event - Crohn's disease Psoriasis year of event - Pustular psoriasis, generalized Was a first-degree family member diagnosed with psoriasis? Convulsive disorder / epilepsy year of event

20 HAVE YOU BEEN DIAGNOSED WITH A MALIGNANT DISEASE/CANCER WITHIN THE LAST 2 YEARS BEFORE THE REACTION OR THAT IS STILL BEING TREATED? Malignant diseases / cancer If yes, please specify: year of event If yes, please specify: HAVE YOU HAD ANY RADIOTHERAPY RECENTLY? Have you ever had X-ray or radiotherapy? (not UV-radiation) If yes, for what indication? date of most recent therapy - lymphoma - brain tumor (please specify) (please specify) - other reason: (please specify) HAVE YOU IN THE PAST HAD ANY TRANSPLANTATION? year of transplantation Transplantation If yes, - Stem cell - other: HAVE YOU IN THE PAST HAD ANY SCAR? year of event SCAR If yes, please specify: (please specify)

21 medication sheet no. of Interview no MEDICATION HISTORY WITHIN 1 MONTH BEFORE HOSPITALIZATION date of admission drug use Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify:

22 medication sheet no. of Interview no MEDICATION HISTORY WITHIN 1 MONTH BEFORE HOSPITALIZATION date of admission drug use Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify:

23 medication sheet no. of Interview no MEDICATION HISTORY WITHIN 1 MONTH BEFORE HOSPITALIZATION date of admission drug use Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake If yes, any adverse reaction If yes, please specify:

24 Have you ever had a rash / skin reaction suspected to be an adverse reaction to a drug? If yes, Drug: Type of eruption: Drug: Type of eruption: Drug: Type of eruption: Drug: Type of eruption: Drug: Type of eruption:

25 DISCHARGE SHEET Discharge diagnoses Results of the present admission 1. Death 2. Discharge date of death date of discharge Mycoplasma infection within two months before admission date of diagnosis If no or yes, by which diagnostic means was the diagnosis reached: serology isolation x-ray PCR unknown

26 MAIN SOURCE OF INFORMATION 1) Clinical pattern of the reaction * Were the skin lesions seen by the investigator in acute stage? If not, please provide the source (e.g., family physician, dermatologist, nurse, family member) 2) Medication history * just patient * just other source If yes, please specify: * both If yes, please specify:

27 ADDITIONAL REMARKS (optional) Please use the fields below to note important additional information. Please stick to the predefined topics and avoid redundancy: Here you can specify additional information regarding ethnic origin: _ Here you can indicate if patient died after discharge. Please provide date of death: Death date Here you can specify any other reason why follow-up investigations (DRESS) /blood sampling (SJS/TEN) could not be done: _ Further relevant remarks: _

28 THERAPY 1 TREATING HOSPITAL hospital no. date of admission _ 1. Burn unit 2. Dept. of dermatology 3. Intensive care unit 4. Pediatric department 5. Internal medicine 6. Other: (please specify) SYSTEMIC THERAPY 1) Corticosteroids If yes, starting date stopping date please enter: Brand name/drug: Dosage: _ Application: p.o. i.v. (if varying please provide minimum and maximum) Comment: 2) IVIG If yes, starting date stopping date please enter: Brand name/drug: Dosage: (if varying please provide minimum and maximum) Comment:

29 THERAPY 2 3) Ciclosporin If yes, starting date stopping date please enter: Brand name/drug: Dosage: (if varying please provide minimum and maximum) Comment: 4) Other systemic treatments If yes, starting date stopping date please enter: Brand name/drug: Dosage: _ Application: p.o. i.v. Comment: (if varying please provide minimum and maximum) If yes, starting date stopping date please enter: Brand name/drug: Dosage: _ Application: p.o. i.v. Comment: (if varying please provide minimum and maximum)

30 THERAPY 3 5) Antibiotics starting date If yes, - did the patient developed septicaemia? date of diagnosis TRANSFER TO OTHER HOSPITAL OR DEPARTMENT FOR TREATMENT OF SCAR no yes If yes, please complete the sheet for the second treating hospital.

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