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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116586374 | 11658637 | 4 | F | 20150103 | 20160719 | 20151026 | 20160721 | PER | PHEH2015US000928 | NOVARTIS | 26.60 | YR | M | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116586374 | 11658637 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 4550 | MG | 22334 | 10 | MG | QD | |||||
| 116586374 | 11658637 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, UNK | 4550 | MG | 22334 | 10 | MG | ||||||
| 116586374 | 11658637 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 UNK, UNK | 4550 | MG | 22334 | 5 | MG | QD | |||||
| 116586374 | 11658637 | 4 | C | VIGABATRIN | VIGABATRIN | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 5 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 6 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 7 | C | POTASSIUM SUPPLEMENTS | 2 | Unknown | U | 0 | |||||||||||
| 116586374 | 11658637 | 8 | C | DIASTAT /01384601/ | 2 | Unknown | UNK, PRN | U | 0 | ||||||||||
| 116586374 | 11658637 | 9 | C | L-LYSINE | LYSINE | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 10 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 11 | C | KENALOG IN ORABASE | TRIAMCINOLONE ACETONIDE | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 13 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 116586374 | 11658637 | 14 | C | CEFDINIR. | CEFDINIR | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116586374 | 11658637 | 1 | Angiomyolipoma |
| 116586374 | 11658637 | 4 | Product used for unknown indication |
| 116586374 | 11658637 | 5 | Product used for unknown indication |
| 116586374 | 11658637 | 6 | Product used for unknown indication |
| 116586374 | 11658637 | 7 | Product used for unknown indication |
| 116586374 | 11658637 | 8 | Product used for unknown indication |
| 116586374 | 11658637 | 9 | Product used for unknown indication |
| 116586374 | 11658637 | 10 | Product used for unknown indication |
| 116586374 | 11658637 | 11 | Product used for unknown indication |
| 116586374 | 11658637 | 12 | Product used for unknown indication |
| 116586374 | 11658637 | 13 | Product used for unknown indication |
| 116586374 | 11658637 | 14 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116586374 | 11658637 | Blood magnesium decreased | |
| 116586374 | 11658637 | Blood potassium decreased | |
| 116586374 | 11658637 | Ear infection | |
| 116586374 | 11658637 | Fungal infection | |
| 116586374 | 11658637 | Hypersensitivity | |
| 116586374 | 11658637 | Irritability | |
| 116586374 | 11658637 | Oral pain | |
| 116586374 | 11658637 | Upper respiratory 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 |
|---|---|---|---|---|---|---|
| 116586374 | 11658637 | 1 | 20131006 | 20150103 | 0 | |
| 116586374 | 11658637 | 2 | 20150113 | 0 | ||
| 116586374 | 11658637 | 3 | 20151106 | 0 |