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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124066672 | 12406667 | 2 | F | 20160506 | 20160629 | 20160526 | 20160705 | PER | PHEH2016US013003 | NOVARTIS | 26.43 | YR | F | Y | 0.00000 | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124066672 | 12406667 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | 22334 | 7.5 | MG | QD | ||||||
| 124066672 | 12406667 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 124066672 | 12406667 | 3 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | Y | 0 | ||||||||||
| 124066672 | 12406667 | 4 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 5 | C | KARIVA | DESOGESTRELETHINYL ESTRADIOL | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 6 | C | MIRENA | LEVONORGESTREL | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 7 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 8 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 9 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 10 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 11 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 124066672 | 12406667 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 124066672 | 12406667 | 13 | C | SIROLIMUS. | SIROLIMUS | 1 | Topical | UNK, PRN | U | 0 | LOTION | ||||||||
| 124066672 | 12406667 | 14 | C | IRON | IRON | 1 | Unknown | U | 0 | ||||||||||
| 124066672 | 12406667 | 15 | C | RISPERDAL | RISPERIDONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124066672 | 12406667 | 1 | Kidney angiomyolipoma |
| 124066672 | 12406667 | 2 | Astrocytoma, low grade |
| 124066672 | 12406667 | 3 | Product used for unknown indication |
| 124066672 | 12406667 | 4 | Product used for unknown indication |
| 124066672 | 12406667 | 5 | Product used for unknown indication |
| 124066672 | 12406667 | 6 | Product used for unknown indication |
| 124066672 | 12406667 | 7 | Product used for unknown indication |
| 124066672 | 12406667 | 8 | Product used for unknown indication |
| 124066672 | 12406667 | 9 | Product used for unknown indication |
| 124066672 | 12406667 | 10 | Product used for unknown indication |
| 124066672 | 12406667 | 11 | Product used for unknown indication |
| 124066672 | 12406667 | 12 | Product used for unknown indication |
| 124066672 | 12406667 | 13 | Product used for unknown indication |
| 124066672 | 12406667 | 14 | Product used for unknown indication |
| 124066672 | 12406667 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124066672 | 12406667 | Dysphonia | |
| 124066672 | 12406667 | Ear infection | |
| 124066672 | 12406667 | Headache | |
| 124066672 | 12406667 | Rash | |
| 124066672 | 12406667 | Rash pruritic |
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 |
|---|---|---|---|---|---|---|
| 124066672 | 12406667 | 1 | 20160504 | 0 | ||
| 124066672 | 12406667 | 2 | 20160616 | 0 |