Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108713545 | 10871354 | 5 | F | 20150116 | 20160705 | 20150226 | 20160715 | EXP | JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-03495NB | BOEHRINGER INGELHEIM | SASAKI Y,OTSUKA N,KIDA H,UTSUNOMIYA A,TANAKA A,OZUSAWA H,ET AL. A CASE OF STEVENS-JOHNSON SYNDROME (SJS) WHICH OCCURRED AFTER AFATINIB ADMINISTRATION IN A PATIENT WITH LUNG ADENOCARCINOMA. -- 2015;. | 65.28 | YR | F | Y | 44.70000 | KG | 20160715 | OT | COUNTRY NOT SPECIFIED | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108713545 | 10871354 | 1 | PS | GILOTRIF | AFATINIB | 1 | Oral | 40 MG | Y | 201292 | 40 | MG | FILM COATED TABLET | QD | |||||
| 108713545 | 10871354 | 2 | SS | GILOTRIF | AFATINIB | 1 | Oral | 30 MG | Y | 201292 | 30 | MG | FILM COATED TABLET | QD | |||||
| 108713545 | 10871354 | 3 | SS | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 15 MG | Y | 0 | 15 | MG | TABLET | QD | |||||
| 108713545 | 10871354 | 4 | SS | MINOMYCIN | MINOCYCLINE HYDROCHLORIDE | 1 | Oral | 100 MG | Y | 0 | 100 | MG | TABLET | QD | |||||
| 108713545 | 10871354 | 5 | SS | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 ANZ | Y | 0 | TABLET | QD | |||||||
| 108713545 | 10871354 | 6 | C | RINDERON V | BETAMETHASONE VALERATE | 1 | Oral | 2 MG | 0 | 2 | MG | TABLET | QD | ||||||
| 108713545 | 10871354 | 7 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 2 ANZ | 0 | TABLET | QD | ||||||||
| 108713545 | 10871354 | 8 | C | URSO | URSODIOL | 1 | Oral | 300 MG | 0 | 300 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108713545 | 10871354 | 1 | Lung adenocarcinoma |
| 108713545 | 10871354 | 3 | Prophylaxis against gastrointestinal ulcer |
| 108713545 | 10871354 | 4 | Rash |
| 108713545 | 10871354 | 5 | Pneumocystis jirovecii pneumonia |
| 108713545 | 10871354 | 6 | Oedema |
| 108713545 | 10871354 | 7 | Product used for unknown indication |
| 108713545 | 10871354 | 8 | Liver disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108713545 | 10871354 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108713545 | 10871354 | Conjunctivitis | |
| 108713545 | 10871354 | Decreased appetite | |
| 108713545 | 10871354 | Liver disorder | |
| 108713545 | 10871354 | Nausea | |
| 108713545 | 10871354 | Stevens-Johnson syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 108713545 | 10871354 | 1 | 20150108 | 20150120 | 0 | |
| 108713545 | 10871354 | 2 | 20150127 | 20150209 | 0 | |
| 108713545 | 10871354 | 3 | 20150106 | 20150216 | 0 | |
| 108713545 | 10871354 | 4 | 20150108 | 20150215 | 0 | |
| 108713545 | 10871354 | 5 | 20150120 | 20150210 | 0 | |
| 108713545 | 10871354 | 6 | 20150106 | 20150218 | 0 | |
| 108713545 | 10871354 | 7 | 20150109 | 20150210 | 0 | |
| 108713545 | 10871354 | 8 | 20150129 | 20150210 | 0 |