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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118700003 | 11870000 | 3 | F | 20140624 | 20160824 | 20151228 | 20160831 | PER | PHEH2014US012820 | NOVARTIS | 4.00 | YR | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118700003 | 11870000 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 2 MG, QD (DAILY), SOLUTION | 174 | MG | 22334 | 2 | MG | QD | |||||
| 118700003 | 11870000 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, UNK | 174 | MG | 22334 | 2.5 | MG | ||||||
| 118700003 | 11870000 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 1.5 MG, UNK | 174 | MG | 22334 | 1.5 | MG | ||||||
| 118700003 | 11870000 | 4 | C | VALPROATE | VALPROIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 5 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 6 | C | MELATONIN | MELATONIN | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 7 | C | BANZEL | RUFINAMIDE | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 8 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 118700003 | 11870000 | 9 | C | ONFI | CLOBAZAM | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 10 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | U | 0 | ||||||||||
| 118700003 | 11870000 | 11 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118700003 | 11870000 | 1 | Ganglioglioma |
| 118700003 | 11870000 | 2 | Astrocytoma, low grade |
| 118700003 | 11870000 | 4 | Product used for unknown indication |
| 118700003 | 11870000 | 5 | Product used for unknown indication |
| 118700003 | 11870000 | 6 | Product used for unknown indication |
| 118700003 | 11870000 | 7 | Product used for unknown indication |
| 118700003 | 11870000 | 8 | Product used for unknown indication |
| 118700003 | 11870000 | 9 | Product used for unknown indication |
| 118700003 | 11870000 | 10 | Product used for unknown indication |
| 118700003 | 11870000 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118700003 | 11870000 | Abnormal behaviour | |
| 118700003 | 11870000 | Adenovirus infection | |
| 118700003 | 11870000 | Blood cholesterol increased | |
| 118700003 | 11870000 | Bowel movement irregularity | |
| 118700003 | 11870000 | Cognitive disorder | |
| 118700003 | 11870000 | Cough | |
| 118700003 | 11870000 | Diarrhoea | |
| 118700003 | 11870000 | Drug level increased | |
| 118700003 | 11870000 | Ear infection | |
| 118700003 | 11870000 | Fatigue | |
| 118700003 | 11870000 | Flat affect | |
| 118700003 | 11870000 | Flatulence | |
| 118700003 | 11870000 | Infection | |
| 118700003 | 11870000 | Metabolic disorder | |
| 118700003 | 11870000 | Oropharyngeal pain | |
| 118700003 | 11870000 | Pyrexia | |
| 118700003 | 11870000 | Sinus congestion | |
| 118700003 | 11870000 | Sinusitis | |
| 118700003 | 11870000 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 118700003 | 11870000 | 1 | 20140622 | 20150112 | 0 | |
| 118700003 | 11870000 | 2 | 20151125 | 0 |