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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124691212 | 12469121 | 2 | F | 20141207 | 20160815 | 20160615 | 20160822 | EXP | JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-17119NB | BOEHRINGER INGELHEIM | 77.12 | YR | F | Y | 44.80000 | KG | 20160823 | MD | JP | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124691212 | 12469121 | 1 | PS | GILOTRIF | AFATINIB | 1 | Unknown | 40 MG | Y | 201292 | 40 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 2 | SS | GILOTRIF | AFATINIB | 1 | Unknown | 40 MG | Y | 201292 | 40 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 3 | SS | GILOTRIF | AFATINIB | 1 | Unknown | 40 MG | Y | 201292 | 40 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 4 | SS | GILOTRIF | AFATINIB | 1 | Unknown | 40 MG | Y | 201292 | 40 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 5 | SS | GILOTRIF | AFATINIB | 1 | Unknown | 30 MG | Y | 201292 | 30 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 6 | SS | GILOTRIF | AFATINIB | 1 | Unknown | 30 MG | Y | 201292 | 30 | MG | FILM COATED TABLET | QD | |||||
| 124691212 | 12469121 | 7 | SS | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124691212 | 12469121 | 1 | Lung adenocarcinoma |
| 124691212 | 12469121 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124691212 | 12469121 | Abdominal pain | |
| 124691212 | 12469121 | Acne | |
| 124691212 | 12469121 | Bronchitis | |
| 124691212 | 12469121 | Cheilitis | |
| 124691212 | 12469121 | Constipation | |
| 124691212 | 12469121 | Dehydration | |
| 124691212 | 12469121 | Diarrhoea | |
| 124691212 | 12469121 | Genital haemorrhage | |
| 124691212 | 12469121 | Mucosal inflammation | |
| 124691212 | 12469121 | Paronychia | Paronychia |
| 124691212 | 12469121 | Pruritus | |
| 124691212 | 12469121 | Rash | Rash |
| 124691212 | 12469121 | Sleep disorder | |
| 124691212 | 12469121 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 124691212 | 12469121 | 1 | 20141204 | 20150105 | 0 | |
| 124691212 | 12469121 | 2 | 20150109 | 0 | ||
| 124691212 | 12469121 | 3 | 20150116 | 20150305 | 0 | |
| 124691212 | 12469121 | 4 | 20150312 | 20150430 | 0 | |
| 124691212 | 12469121 | 5 | 20150619 | 20150727 | 0 | |
| 124691212 | 12469121 | 6 | 20151023 | 0 |