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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113309898 | 11330989 | 8 | F | 20150513 | 20160728 | 20150803 | 20160802 | PER | PHEH2015US009851 | NOVARTIS | 23.55 | YR | F | Y | 0.00000 | 20160802 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113309898 | 11330989 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | Y | 22334 | 2.5 | MG | QD | ||||||
| 113309898 | 11330989 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 113309898 | 11330989 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | 22334 | 7.5 | MG | QD | ||||||
| 113309898 | 11330989 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 113309898 | 11330989 | 5 | C | FELBATOL | FELBAMATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113309898 | 11330989 | 6 | C | ZONEGRAN | ZONISAMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113309898 | 11330989 | 7 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113309898 | 11330989 | 5 | Product used for unknown indication |
| 113309898 | 11330989 | 6 | Product used for unknown indication |
| 113309898 | 11330989 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113309898 | 11330989 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113309898 | 11330989 | Abnormal behaviour | |
| 113309898 | 11330989 | Acne | |
| 113309898 | 11330989 | Blood cholesterol increased | |
| 113309898 | 11330989 | Dysmenorrhoea | |
| 113309898 | 11330989 | Lip dry | |
| 113309898 | 11330989 | Malaise | |
| 113309898 | 11330989 | Menstruation irregular | |
| 113309898 | 11330989 | Metrorrhagia | |
| 113309898 | 11330989 | Mouth ulceration | |
| 113309898 | 11330989 | Nasopharyngitis | |
| 113309898 | 11330989 | Ovarian cyst | |
| 113309898 | 11330989 | Pallor | |
| 113309898 | 11330989 | Pyrexia | |
| 113309898 | 11330989 | Rash | |
| 113309898 | 11330989 | Skin lesion | |
| 113309898 | 11330989 | Therapeutic response unexpected | |
| 113309898 | 11330989 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 113309898 | 11330989 | 1 | 20150427 | 0 | ||
| 113309898 | 11330989 | 4 | 20160114 | 20160316 | 0 |