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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114608848 | 11460884 | 8 | F | 20150112 | 20160913 | 20150904 | 20160920 | EXP | PHEH2015US001036 | NOVARTIS | 56.31 | YR | M | Y | 90.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114608848 | 11460884 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 22334 | 5 | MG | QD | |||||||
| 114608848 | 11460884 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | 22334 | ||||||||||||
| 114608848 | 11460884 | 3 | C | DILANTIN SODIUM | PHENYTOIN SODIUM | 1 | Unknown | UNK | Y | 0 | |||||||||
| 114608848 | 11460884 | 4 | C | DILANTIN SODIUM | PHENYTOIN SODIUM | 1 | Unknown | 3 OT, QD (3 A DAY ) | Y | 0 | QD | ||||||||
| 114608848 | 11460884 | 5 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | U | 0 | ||||||||||
| 114608848 | 11460884 | 6 | C | SODIUM POLYSTYRENE SULFONATE. | SODIUM POLYSTYRENE SULFONATE | 1 | Unknown | U | 0 | ||||||||||
| 114608848 | 11460884 | 7 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 114608848 | 11460884 | 8 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114608848 | 11460884 | 1 | Angiomyolipoma |
| 114608848 | 11460884 | 2 | Astrocytoma, low grade |
| 114608848 | 11460884 | 3 | Product used for unknown indication |
| 114608848 | 11460884 | 5 | Product used for unknown indication |
| 114608848 | 11460884 | 6 | Product used for unknown indication |
| 114608848 | 11460884 | 7 | Product used for unknown indication |
| 114608848 | 11460884 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114608848 | 11460884 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114608848 | 11460884 | Acne | |
| 114608848 | 11460884 | Asthenia | |
| 114608848 | 11460884 | Blood potassium increased | |
| 114608848 | 11460884 | Bone pain | |
| 114608848 | 11460884 | Cardiac valve disease | |
| 114608848 | 11460884 | Chronic kidney disease | |
| 114608848 | 11460884 | Cough | |
| 114608848 | 11460884 | Dehydration | |
| 114608848 | 11460884 | Drug level increased | |
| 114608848 | 11460884 | Dyspepsia | |
| 114608848 | 11460884 | Eating disorder | |
| 114608848 | 11460884 | Fluid retention | |
| 114608848 | 11460884 | Ligament sprain | |
| 114608848 | 11460884 | Muscular weakness | |
| 114608848 | 11460884 | Pain | |
| 114608848 | 11460884 | Pruritus | |
| 114608848 | 11460884 | Renal impairment | |
| 114608848 | 11460884 | Scrotal swelling | |
| 114608848 | 11460884 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 114608848 | 11460884 | 1 | 20150105 | 0 | ||
| 114608848 | 11460884 | 4 | 20150420 | 0 |