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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121054714 | 12105471 | 4 | F | 20160122 | 20160902 | 20160223 | 20160912 | EXP | PHEH2016US004143 | NOVARTIS | 35.01 | YR | F | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121054714 | 12105471 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5.0 MG, QD | U | 22334 | 5 | MG | TABLET | QD | |||||
| 121054714 | 12105471 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | U | 22334 | TABLET | ||||||||||
| 121054714 | 12105471 | 3 | C | CALCIUM | CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 5 | C | FANAPT | ILOPERIDONE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 121054714 | 12105471 | 6 | C | ORAP | PIMOZIDE | 1 | Unknown | Y | 0 | ||||||||||
| 121054714 | 12105471 | 7 | C | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | Y | 0 | ||||||||||
| 121054714 | 12105471 | 8 | C | KLONOPIN | CLONAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 9 | C | GEODON | ZIPRASIDONE HYDROCHLORIDEIPRASIDONE MESYLATE | 1 | Unknown | Y | 0 | ||||||||||
| 121054714 | 12105471 | 10 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 11 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 12 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 121054714 | 12105471 | 13 | C | NEXIUM I.V. | ESOMEPRAZOLE SODIUM | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 121054714 | 12105471 | 14 | C | PROVENTIL | ALBUTEROL | 1 | Unknown | UNK UNK, PRN | U | 0 | |||||||||
| 121054714 | 12105471 | 15 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | U | 0 | ||||||||||
| 121054714 | 12105471 | 16 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121054714 | 12105471 | 1 | Angiomyolipoma |
| 121054714 | 12105471 | 2 | Astrocytoma, low grade |
| 121054714 | 12105471 | 3 | Product used for unknown indication |
| 121054714 | 12105471 | 4 | Product used for unknown indication |
| 121054714 | 12105471 | 5 | Product used for unknown indication |
| 121054714 | 12105471 | 6 | Product used for unknown indication |
| 121054714 | 12105471 | 7 | Product used for unknown indication |
| 121054714 | 12105471 | 8 | Product used for unknown indication |
| 121054714 | 12105471 | 9 | Product used for unknown indication |
| 121054714 | 12105471 | 10 | Product used for unknown indication |
| 121054714 | 12105471 | 11 | Product used for unknown indication |
| 121054714 | 12105471 | 12 | Pain |
| 121054714 | 12105471 | 13 | Product used for unknown indication |
| 121054714 | 12105471 | 14 | Product used for unknown indication |
| 121054714 | 12105471 | 15 | Product used for unknown indication |
| 121054714 | 12105471 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121054714 | 12105471 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121054714 | 12105471 | Anxiety | |
| 121054714 | 12105471 | Arrhythmia | |
| 121054714 | 12105471 | Blood cholesterol increased | |
| 121054714 | 12105471 | Drooling | |
| 121054714 | 12105471 | Excessive eye blinking | |
| 121054714 | 12105471 | Fall | |
| 121054714 | 12105471 | Head titubation | |
| 121054714 | 12105471 | Headache | |
| 121054714 | 12105471 | Heart rate irregular | |
| 121054714 | 12105471 | Nervous system disorder | |
| 121054714 | 12105471 | Palpitations | |
| 121054714 | 12105471 | Psychotic disorder | |
| 121054714 | 12105471 | Seizure | |
| 121054714 | 12105471 | Speech disorder | |
| 121054714 | 12105471 | Stress | |
| 121054714 | 12105471 | Syncope | |
| 121054714 | 12105471 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 121054714 | 12105471 | 1 | 20130706 | 20140506 | 0 |