Entry form – CRF AGEP

Data Registry - CRF AGEP

Numbers

Initials of the Patient

Age (year)

Date of birth

Gender

Death before Interview

Participation agreed to by the patient

Hospital Data

Reporting Hospital/Department

Reporting Hospital/Department Number

Reporting Hospital/Departement Date

Treating Hospital/Department

Treating Hospital/Department Number

Treating Hospital/Department Date

Date of Notification

Date of Interview

Transfer from one or more hospitals to the reporting/treating hospital

Transfer from one or more hospitals to the reporting/treating hospital If Yes, first hospital

Transfer from one or more hospitals to the reporting/treating hospital If Yes, first hospital Number

Transfer from one or more hospitals to the reporting/treating hospital If Yes, first hospital Date

Restrospective assessment

Development of skin reaction

Diagnoses and Clinical Course

Admission diagnoses

Diagnoses and Clinical Course Date

Clinical Symptoms

Fever

Fever If Yes, Date of Onset

Fever If Yes, Date of Normalization (if cured before admission)

Fever If Yes, Highest Temperature (degree celcius)

For Cases of AGEP only

Skin Symptoms Burning

Skin Symptoms Burning Date of Onset

Skin Symptoms Pain

Skin Symptoms Pain Date of Onset

Skin Symptoms Pain Date of Resolution (if cured before discharge/death of patient)

Skin Symptoms Pruritus

Skin Symptoms Pruritus Date onset

Skin Symptoms Pruritus Date of Resolution (if cured before discharge/death of patient)

Skin Symptoms Erythema, Exanthema

Skin Symptoms Erythema, Exanthema Date of Onset

Skin Symptoms Erythema, Exanthema If Yes

Diffuse Erythema

Utricarial

Maculopapular

Purpura

Target lesions

Others

Unknwon

Localization of exanthema

Maximum extent of exanthema (percentage related to the BSA)

Facial edema

Facial Edema Date of onset

Facial edema: Date of Resolution (If cured before discharge/death of patient)

For Cases of AGEP only: Pustules

Pustules

Pustules If Yes, few (5cm

Maximum of detachment (percentage related to the BSA)

Post pustular desquamation

Post pustular desquamation Data of Onset

Post pustular desquamation Date of Resolution (if cured before discharge/death of patient)

For Cases of AGEP only: Mucosal Erosions Lips

Mucosal Erosions Lips

Mucosal Erosions Lips Date of onset

Mucosal Erosions Lips Date of resolution (if cured before discharge/death of patient)

Mucosal Erosions Mouth

Mucosal Erosions Mouth Date of onset

Mucosal Erosions Mouth Date of resolution (if cured before discharge/death of patient)

Mucosal Erosions Eyes

Mucosal Erosions Eyes Date of onset

Mucosal Erosions Eyes Date of resolution (if cured before discharge/death of patient)

Mucosal Erosions Genital

Mucosal Erosions Genital Date of onset

Mucosal Erosions Genitals Date of resolution (if cured before discharge/death of patient)

Mucosal Erosions Anal

Mucosal Erosions Anal Date of onset

Mucosal Erosions Anal Date of resolution (if cured before discharge/death of patient)

Mucosal Erosions Nasal

Mucosal Erosions Nasal Date of onset

Mucosal Erosions Nasal Date of resolution (if cured before discharge/death of patient)

Laboratory Findings

Leukocyte On Admission (/microliter)

Leukocyte Not Done

Neutrophils On Admission (/microliter)

Neutrophils On Maximum (/microliter)

Neutrophils Not Done

Eosinophils On Admission (/microliter)

Eosinophils On Maximum (/microliter)

Eosinophils Not Done

Pathological Renal Function

If Yes, highest pathological values

Pathological Liver Function

If Yes, highest pathological values

For All Cases: Further Information for Case Validation

Photographs

Photographs Date of First Occurence

Biopsy

Biopsy Date of First Occurence

Diagnosis by a dermatologist

Diagnosis by a dermatologist Date of First Occurence

Diagnosis by a dermatologist IF YES, please specify

Furhter photographs/biopsies and comments

Symptoms/Events Within 1 Month Before the Recent Skin Reaction

Herpes Labialis or Fever Blisters

Herpes Labialis or Fever Blisters Data of Onset

Herpes Labialis or Fever Blisters Date Of Normalization (if cured before admission)

Do you have recurrent Herpes labialis or fever blisters?

Do you have recurrent Herpes labialis or fever blisters? Date of last eruption

Herpes genitalis

Herpes genitalis Data of Onset

Herpes genitalis Date Of Normalization (if cured before admission)

Do you have recurrent Herpes genitalis?

Do you have recurrent Herpes genitalis? Date of last eruption (copy)

Infections

Infections If Yes, Influenza/Influenza-like illnes

Infections If Yes, Influenza/Influenza-like illnes Data of Onset

Infections If Yes, Influenza/Influenza-like illness Date of Normalization (if cured before admission)

Infections If Yes, Was the diagnosis confirmed by a physician?

Infections If Yes, Was any diagnosis test performed?

Infections If Yes, Was any medication taken for treatment?

Infections If Yes, Respiratory Tract Infection

Infections If Yes, Respiratory Tract Infection Date of Onset

Infections If Yes, Respiratory Tract Infection Date of Normalization (if cured before admission)

Infections If Yes, Was the diagnosis confirmed by a physician?

Infections If Yes, Was any diagnosis test performed?

Infections If Yes, Was any medication taken for treatment?

Infections If Yes, Urinary Tract Infection

Infections If Yes, Urinary Tract Infection Date of Onset

Infections If Yes, Urinary Tract Infection Date of Normalization (if cured before admission)

Infections If Yes, Was the diagnosis confirmed by a physician?

Infections If Yes, Was any diagnosis test performed?

Infections If Yes, Was any medication taken for treatment?

Infections If Yes, Other Infection

Infections If Yes, Other Infection Date of Onset

Infections If Yes, Other Infection Date of Normalization (if cured before admission)

Infections If Yes, Was the diagnosis confirmed by a physician?

Infections If Yes, Was any diagnosis test performed?

Infections If Yes, Was any medication taken for treatment?

HIV-status HIV

HIV-status AIDS

HIV-status If Yes for HIV or AIDS, most recent CD4 count per micro liter

Disease

Have you had any of the following Disease that are still active? Severe liver disorders

Severe liver disorders Year of Event

Severe liver disorders If Yes, please specify

Have you had any of the following Disease that are still active? Severe kidney disorders

Severe kidney disorders

Severe liver kidney Year of Event

Severe kidney disorders If Yes, please specify

Have you had any of the following Disease that are still active? Rheumatic/collagen-vascular disease

Rheumatic/collagen-vascular disease If Yes, Rheumatoid Polyarthritis

Rheumatic/collagen-vascular disease If Yes, Rheumatoid Polyarthritis, Year of Event

Rheumatic/collagen-vascular disease If Yes, Systemic Lupus Erythematosus

Rheumatic/collagen-vascular disease If Yes, Systemic Lupus Erythematosus, Year of Event

Have you had any of the following Disease that are still active? If Yes, Others

Have you had any of the following Disease that are still active? If Yes, Others, Year of Event

Rheumatic/collagen-vascular disease If Yes, Please specify

Was a first degree family member diagnosed with any rheumatic/collagen-vascular disease?

Have you had any of the following Disease that are still active? Inflammatory bowel disease

Have you had any of the following Disease that are still active? Colitis Ulcerosa

Have you had any of the following Disease that are still active? Colitis Ulcerosa Year of Event

Have you had any of the following Disease that are still active? Colitis Ulcerosa

Have you had any of the following Disease that are still active? Colitis Ulcerosa, Year of Event

Have you had any of the following Disease that are still active? Crohn's Disease

Have you had any of the following Disease that are still active? Crohn's Disease, Year of Event

Have you had any of the following Disease that are still active? Psoriasis

Have you had any of the following Disease that are still active? Psoriasis, Year of Event

Psoriasis If yes, pustular psoraisis, generalized

Was a first degree family member diagnosed with psoriasis?

Have you had any of the following Disease that are still active? Convulsive disorder/epilepsy

Have you had any of the following Disease that are still active? Convulsive disorder/epilepsy, Year of Event

Have you been diagnosed with a malignant disease/cancer within the last 2 years before the reaction or that is still being treated? Maglinant Diseases/cance

Maglinant Diseases/cancer If Yes, please specify

Maglinant Diseases/cancer If Yes, Year of event

Have you had X-ray or radiotherapy? (not UV radiation)

Date of Most Recent Therapy

If Yes, for what Indication? Lymphoma

If Yes, for what Indication? Brain Tumor

If Yes, for what Indication? Other Reasons (pleace specify)

Have you in the past had any transplantation?

If yes, Stem Cell

If yes, Others

Have you in the past had any scar?

Have you in the past had any scar? If yes, please specify

Medication History Within 1 Month Before Hospitalization

Date of admission

Drug use

Drug

Indication

Type of application

Dose

Begin of Intake (day, month, year)

End of Intake (day, month, year) (copy)

Frequency

Previous intake of Drug

Previous intake of Drug If Yes, any adverse reaction

Previous intake of Drug If any adverse reaction, please specify

Have you ever had a rash/skin reaction suspected to be an adverse reaction to a drug?

If Yes, Name of Drug

If Yes, Type of Eruption

Discharge Diagnoses

Results of the present admission: Death

Date of Discharge

Mycoplasma Infection within 2 months before admission:

Date of Diagnosis

If no or yes, by which diagnostic means was the diagnosis reached?

Serology

Isolation

X-ray

PCR

Unknown

Main Source of Information

Were the skin lesions seen by the investigator in actue stage?

If not, please provide the source (e.g., family physician, dermatologist, nurse, family member)

Main Source of Information: Medication History

Just Patient

Just other sources

both

other source, if yes, please specify

both, If yes, please specify

Additional Remarks

Ethnic origin

Indicate if patient died after discharge

Date of Death

Specify any other reason why follow-up investigations (DRESS) /blood sampling (SJS/TEN) could not be done

Further relevant remarks

For cases of AGEP only: Unit of Treatment Burn Unit

Burn Unit

Dept of Dermatology

Intensive Care Unit

Pediatric Department

Internal Medicine

Others (Please specify)