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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112868115 | 11286811 | 5 | F | 20150612 | 20160729 | 20150721 | 20160805 | PER | PHEH2015US011548 | NOVARTIS | 19.22 | YR | M | Y | 81.90000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112868115 | 11286811 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 22334 | 7.5 | MG | QD | |||||||
| 112868115 | 11286811 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | QD | |||||||
| 112868115 | 11286811 | 3 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 112868115 | 11286811 | 4 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 112868115 | 11286811 | 5 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 112868115 | 11286811 | 6 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 112868115 | 11286811 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 112868115 | 11286811 | 8 | C | TOPAMAX | TOPIRAMATE | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 112868115 | 11286811 | 9 | C | FISH OIL | FISH OIL | 1 | Unknown | U | 0 | ||||||||||
| 112868115 | 11286811 | 10 | C | SEPRA S | 2 | Unknown | U | 0 | |||||||||||
| 112868115 | 11286811 | 11 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 112868115 | 11286811 | 12 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112868115 | 11286811 | 1 | Brain neoplasm benign |
| 112868115 | 11286811 | 3 | Product used for unknown indication |
| 112868115 | 11286811 | 4 | Product used for unknown indication |
| 112868115 | 11286811 | 5 | Product used for unknown indication |
| 112868115 | 11286811 | 6 | Product used for unknown indication |
| 112868115 | 11286811 | 7 | Product used for unknown indication |
| 112868115 | 11286811 | 8 | Product used for unknown indication |
| 112868115 | 11286811 | 9 | Product used for unknown indication |
| 112868115 | 11286811 | 10 | Product used for unknown indication |
| 112868115 | 11286811 | 11 | Product used for unknown indication |
| 112868115 | 11286811 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112868115 | 11286811 | Agitation | |
| 112868115 | 11286811 | Drug level below therapeutic | |
| 112868115 | 11286811 | Irritability | |
| 112868115 | 11286811 | Mouth ulceration | |
| 112868115 | 11286811 | 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 |
|---|---|---|---|---|---|---|
| 112868115 | 11286811 | 2 | 20140421 | 0 |