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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115804526 | 11580452 | 6 | F | 20150924 | 20160713 | 20150930 | 20160715 | PER | PHEH2015US018959 | NOVARTIS | 51.84 | YR | F | Y | 0.00000 | 20160716 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115804526 | 11580452 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD (DAILY) | U | 22334 | 7.5 | MG | TABLET | QD | |||||
| 115804526 | 11580452 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | U | 22334 | TABLET | ||||||||||
| 115804526 | 11580452 | 3 | C | FLUOXETIN | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 4 | C | TEGRETOL | CARBAMAZEPINE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 5 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 7 | C | POTASSIUM | POTASSIUM | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 8 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 9 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 10 | C | PROBIOTICS NOS | PROBIOTICS NOS | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 11 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 12 | C | MULTI VITAMIN | VITAMINS | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 13 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 15 | C | TRAZODON | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 16 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 17 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 18 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 19 | C | ABILIFY | ARIPIPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 20 | C | HYDROCHOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 21 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | U | 0 | ||||||||||
| 115804526 | 11580452 | 22 | C | ASPIRIN /00346701/ | ASCORBIC ACIDASPIRIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115804526 | 11580452 | 1 | Astrocytoma, low grade |
| 115804526 | 11580452 | 2 | Acute myeloid leukaemia |
| 115804526 | 11580452 | 3 | Product used for unknown indication |
| 115804526 | 11580452 | 4 | Product used for unknown indication |
| 115804526 | 11580452 | 5 | Product used for unknown indication |
| 115804526 | 11580452 | 6 | Product used for unknown indication |
| 115804526 | 11580452 | 7 | Product used for unknown indication |
| 115804526 | 11580452 | 8 | Product used for unknown indication |
| 115804526 | 11580452 | 9 | Product used for unknown indication |
| 115804526 | 11580452 | 10 | Product used for unknown indication |
| 115804526 | 11580452 | 11 | Product used for unknown indication |
| 115804526 | 11580452 | 12 | Product used for unknown indication |
| 115804526 | 11580452 | 13 | Product used for unknown indication |
| 115804526 | 11580452 | 14 | Product used for unknown indication |
| 115804526 | 11580452 | 15 | Product used for unknown indication |
| 115804526 | 11580452 | 16 | Product used for unknown indication |
| 115804526 | 11580452 | 17 | Product used for unknown indication |
| 115804526 | 11580452 | 18 | Product used for unknown indication |
| 115804526 | 11580452 | 19 | Product used for unknown indication |
| 115804526 | 11580452 | 20 | Product used for unknown indication |
| 115804526 | 11580452 | 21 | Product used for unknown indication |
| 115804526 | 11580452 | 22 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115804526 | 11580452 | Blood cholesterol increased | |
| 115804526 | 11580452 | Blood creatinine increased | |
| 115804526 | 11580452 | Blood triglycerides increased | |
| 115804526 | 11580452 | Diplopia | |
| 115804526 | 11580452 | Disease progression | |
| 115804526 | 11580452 | Drug ineffective | |
| 115804526 | 11580452 | Headache | |
| 115804526 | 11580452 | Migraine | |
| 115804526 | 11580452 | Narcolepsy | |
| 115804526 | 11580452 | Renal impairment | |
| 115804526 | 11580452 | Urinary tract infection | |
| 115804526 | 11580452 | 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 |
|---|---|---|---|---|---|---|
| 115804526 | 11580452 | 1 | 20141213 | 20160602 | 0 |