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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113151567 | 11315156 | 7 | F | 20140801 | 20160726 | 20150727 | 20160729 | PER | PHEH2014US016053 | NOVARTIS | 59.67 | YR | M | Y | 0.00000 | 20160729 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113151567 | 11315156 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, DAILY | Y | 22334 | 10 | MG | TABLET | QD | |||||
| 113151567 | 11315156 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | 22334 | 7.5 | MG | TABLET | QD | |||||
| 113151567 | 11315156 | 3 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 4 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 5 | C | ASTELIN | AZELASTINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | NASAL SPRAY | ||||||||
| 113151567 | 11315156 | 6 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 7 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 8 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Unknown | 20 MG, COUPLE OF WEEKS AGO | U | 0 | 20 | MG | |||||||
| 113151567 | 11315156 | 9 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Unknown | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 113151567 | 11315156 | 10 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, BID | U | 0 | 5 | MG | BID | ||||||
| 113151567 | 11315156 | 12 | C | ROZEREM | RAMELTEON | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 13 | C | UROXATRAL | ALFUZOSIN HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 14 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 15 | C | VITAMIN B | VITAMIN B | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 16 | C | MEGARED PLANT OMEGA | 2 | Unknown | UNK | U | 0 | ||||||||||
| 113151567 | 11315156 | 17 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 18 | C | NASAL SPRAY | UNSPECIFIED INGREDIENT | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 19 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113151567 | 11315156 | 20 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113151567 | 11315156 | 1 | Angiomyolipoma |
| 113151567 | 11315156 | 3 | Product used for unknown indication |
| 113151567 | 11315156 | 4 | Product used for unknown indication |
| 113151567 | 11315156 | 5 | Product used for unknown indication |
| 113151567 | 11315156 | 6 | Product used for unknown indication |
| 113151567 | 11315156 | 7 | Product used for unknown indication |
| 113151567 | 11315156 | 10 | Product used for unknown indication |
| 113151567 | 11315156 | 12 | Product used for unknown indication |
| 113151567 | 11315156 | 13 | Product used for unknown indication |
| 113151567 | 11315156 | 14 | Product used for unknown indication |
| 113151567 | 11315156 | 15 | Product used for unknown indication |
| 113151567 | 11315156 | 16 | Product used for unknown indication |
| 113151567 | 11315156 | 17 | Musculoskeletal stiffness |
| 113151567 | 11315156 | 18 | Product used for unknown indication |
| 113151567 | 11315156 | 19 | Product used for unknown indication |
| 113151567 | 11315156 | 20 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113151567 | 11315156 | Abdominal discomfort | |
| 113151567 | 11315156 | Blood creatinine increased | |
| 113151567 | 11315156 | Blood pressure increased | |
| 113151567 | 11315156 | Constipation | |
| 113151567 | 11315156 | Epistaxis | |
| 113151567 | 11315156 | Flatulence | |
| 113151567 | 11315156 | Headache | |
| 113151567 | 11315156 | Heart rate increased | |
| 113151567 | 11315156 | Nausea | |
| 113151567 | 11315156 | Rash | |
| 113151567 | 11315156 | Stomatitis | |
| 113151567 | 11315156 | Weight decreased | |
| 113151567 | 11315156 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 113151567 | 11315156 | 1 | 20140625 | 0 |