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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118941545 | 11894154 | 5 | F | 20151230 | 20160916 | 20160107 | 20160921 | PER | PHEH2016US000520 | NOVARTIS | 4.13 | YR | F | Y | 0.00000 | 20160921 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118941545 | 11894154 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | Y | 22334 | 2.5 | MG | TABLET | QD | |||||
| 118941545 | 11894154 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Y | 22334 | TABLET | ||||||||||
| 118941545 | 11894154 | 3 | C | FIBER | PSYLLIUM HUSK | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118941545 | 11894154 | 1 | Astrocytoma, low grade |
| 118941545 | 11894154 | 2 | Ganglioglioma |
| 118941545 | 11894154 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118941545 | 11894154 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118941545 | 11894154 | Diarrhoea | |
| 118941545 | 11894154 | Kidney infection | |
| 118941545 | 11894154 | Malaise | |
| 118941545 | 11894154 | Mouth ulceration | |
| 118941545 | 11894154 | Pyrexia | |
| 118941545 | 11894154 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 118941545 | 11894154 | 1 | 20151228 | 0 |