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 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 date of onset date of normalization* highest temperature ( C) method of measurement * if cured before admission

4 - 4 B - FOR CASES OF AGEP ONLY SKIN SYMPTOMS Subjective symptoms Burning date of onset date of resolution* Pain Pruritus Erythema, exanthema - diffuse erythema localization of exanthema: - urticarial mainly folds - maculopapular widespread - purpura face - target lesions other: - other: - unknown unknown Maximum extent of exanthema (percentage related to the BSA) Facial edema date of onset date of resolution* * if cured before discharge / death of patient (if information of grey marked fields could not observed before discharge please try to verify information via phone call)

5 - 5 B - FOR CASES OF AGEP ONLY Pustules - few (< 25) - many (> 25; dozens) - unknown date of onset date of resolution* Type of pustules: - follicular - non-follicular - unknown type of pustules Localization of pustules: - mainly folds - folds spared - widespread - face - other: - unknown Blisters / epidermal sheets > 5cm date of onset date of resolution* Maximum of detachment (percentage related to the BSA) Postpustular desquamation date of onset date of resolution* * if cured before discharge / death of patient (if information of grey marked fields could not observed before discharge please try to verify information via phone call)

6 - 6 B FOR CASES OF AGEP ONLY MUCOSAL EROSIONS Lips date of onset date of resolution* Mouth Eyes Genital Anal Nasal LABORATORY FINDINGS - Leucocytes On admission: /?l not done Maximum: /?l date of maximum - Neutrophils On admission: /?l not done Maximum: /?l date of maximum - Eosinophils not done On admission: /?l date of maximum Maximum: /?l - Pathological renal-function highest pathological values: _ - Pathological liver-function highest pathological values: _ * if cured before discharge / death of patient

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

8 - 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

9 - 9 - SYMPTOMS / EVENTS WITHIN 1 MONTH BEFORE THE RECENT SKIN REACTION Infections - 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 Was the diagnosis confirmed by a physician? Was any diagnostic test performed? Was any medication taken for treatment? - other infection 2 *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?l: *if cured before admission

10 HAVE YOU HAD ANY OF THE FOLLOWING DISEASES THAT ARE STILL ACTIVE? Severe liver disorders year of event Severe kidney disorders year of event Rheumatic / collagen-vascular disease - rheumatoid polyarthritis year of event - systemic lupus erythematosus - other: 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

11 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 please specify: year of event please specify: HAVE YOU HAD ANY RADIOTHERAPY RECENTLY? Have you ever had X-ray or radiotherapy? (not UV-radiation) for what indication? date of most recent therapy - lymphoma - brain tumor - other reason: HAVE YOU IN THE PAST HAD ANY TRANSPLANTATION? year of transplantation Transplantation - Stem cell - other: _ HAVE YOU IN THE PAST HAD ANY SCAR? year of event SCAR please specify:

12 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 any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify:

13 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 any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify:

14 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 any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify: Drug Indication Type of application Dose Begin of intake End of intake Frequency day month year day month year previous intake any adverse reaction please specify:

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

16 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

17 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 please specify: * both please specify:

18 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:

19 FOR CASES OF AGEP ONLY THERAPY UNIT OF TREATMENT 1. Burn unit 2. Dept. of dermatology 3. Intensive care unit 4. Pediatric department 5. Internal medicine 6. Other: Did the patient receive any systemic treatment because of the pustular disorder (only to be completed, if not stated in the discharge letter)? SYSTEMIC THERAPY (steroids, other immunomodulating agents, IVIG, antibiotics, retinoids and anti-tnf) Brand name: Dosage: Application: p.o. i.v. Brand name: Dosage: Application: p.o. i.v. Brand name: Dosage: Application: p.o. i.v. Brand name: Dosage: Application: p.o. i.v.