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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113840463 | 11384046 | 3 | F | 20150115 | 20160721 | 20150815 | 20160725 | EXP | PHEH2015US001775 | NOVARTIS | 30.22 | YR | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113840463 | 11384046 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | Y | 22334 | 10 | MG | TABLET | QD | |||||
| 113840463 | 11384046 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | TABLET | QD | |||||
| 113840463 | 11384046 | 3 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | U | 0 | ||||||||||
| 113840463 | 11384046 | 4 | C | NAPROSYN | NAPROXEN | 1 | Unknown | Y | 0 | ||||||||||
| 113840463 | 11384046 | 5 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | PRN | U | 0 | |||||||||
| 113840463 | 11384046 | 6 | C | LORATADINE. | LORATADINE | 1 | Unknown | U | 0 | ||||||||||
| 113840463 | 11384046 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK UNK, PRN | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113840463 | 11384046 | 1 | Angiomyolipoma |
| 113840463 | 11384046 | 3 | Product used for unknown indication |
| 113840463 | 11384046 | 4 | Product used for unknown indication |
| 113840463 | 11384046 | 5 | Product used for unknown indication |
| 113840463 | 11384046 | 6 | Product used for unknown indication |
| 113840463 | 11384046 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113840463 | 11384046 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113840463 | 11384046 | Arthralgia | |
| 113840463 | 11384046 | Chronic kidney disease | |
| 113840463 | 11384046 | Dry skin | |
| 113840463 | 11384046 | Dyspnoea | |
| 113840463 | 11384046 | Feeling abnormal | |
| 113840463 | 11384046 | Joint swelling | |
| 113840463 | 11384046 | Migraine | |
| 113840463 | 11384046 | Mouth ulceration | |
| 113840463 | 11384046 | Nasal congestion | |
| 113840463 | 11384046 | Oral pain | |
| 113840463 | 11384046 | Oropharyngeal pain | |
| 113840463 | 11384046 | Personality change | |
| 113840463 | 11384046 | Skin atrophy | |
| 113840463 | 11384046 | Skin mass | |
| 113840463 | 11384046 | Speech disorder | |
| 113840463 | 11384046 | Urinary tract 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 |
|---|---|---|---|---|---|---|
| 113840463 | 11384046 | 1 | 20150111 | 0 | ||
| 113840463 | 11384046 | 2 | 20150123 | 0 |