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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114447855 | 11444785 | 5 | F | 20151108 | 20160706 | 20150902 | 20160708 | PER | PHEH2015US000977 | NOVARTIS | 2.37 | YR | M | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114447855 | 11444785 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 3 MG, QD | 22334 | 3 | MG | TABLET | QD | ||||||
| 114447855 | 11444785 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2 TO 3 MG, UNK | 22334 | TABLET | |||||||||
| 114447855 | 11444785 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2 MG, UNK | 22334 | 2 | MG | TABLET | |||||||
| 114447855 | 11444785 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 3 MG, UNK | 22334 | 3 | MG | TABLET | |||||||
| 114447855 | 11444785 | 5 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 4 MG, UNK | 22334 | 4 | MG | TABLET | |||||||
| 114447855 | 11444785 | 6 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2 TO 3 MG AND OCCASIONALLY 4 MG | 22334 | 4 | MG | TABLET | |||||||
| 114447855 | 11444785 | 7 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2 TO 3 MG, UNK | 22334 | 3 | MG | TABLET | |||||||
| 114447855 | 11444785 | 8 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 3 MG, QD | 22334 | 3 | MG | TABLET | QD | ||||||
| 114447855 | 11444785 | 9 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 4 MG, DAILY | 22334 | 4 | MG | TABLET | QD | ||||||
| 114447855 | 11444785 | 10 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, UNK | 22334 | 7.5 | MG | TABLET | QD | ||||||
| 114447855 | 11444785 | 11 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | TABLET | QD | ||||||
| 114447855 | 11444785 | 12 | C | VIGABATRINE | VIGABATRIN | 1 | Unknown | U | 0 | ||||||||||
| 114447855 | 11444785 | 13 | C | TAURINE | TAURINE | 1 | Unknown | U | 0 | ||||||||||
| 114447855 | 11444785 | 14 | C | SABRIL | VIGABATRIN | 1 | Unknown | U | 0 | ||||||||||
| 114447855 | 11444785 | 15 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 114447855 | 11444785 | 16 | C | RAPAMYCIN | SIROLIMUS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114447855 | 11444785 | 1 | Ganglioglioma |
| 114447855 | 11444785 | 12 | Seizure |
| 114447855 | 11444785 | 13 | Product used for unknown indication |
| 114447855 | 11444785 | 14 | Seizure |
| 114447855 | 11444785 | 15 | Product used for unknown indication |
| 114447855 | 11444785 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114447855 | 11444785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114447855 | 11444785 | Blood cholesterol increased | |
| 114447855 | 11444785 | Hand-foot-and-mouth disease | |
| 114447855 | 11444785 | Malaise | |
| 114447855 | 11444785 | Mouth swelling | |
| 114447855 | 11444785 | Nasopharyngitis | |
| 114447855 | 11444785 | Oral pain | |
| 114447855 | 11444785 | Pyrexia | |
| 114447855 | 11444785 | Rash | |
| 114447855 | 11444785 | Respiratory tract infection | |
| 114447855 | 11444785 | Seizure | |
| 114447855 | 11444785 | Staphylococcal infection | |
| 114447855 | 11444785 | Stomatitis | |
| 114447855 | 11444785 | 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 |
|---|---|---|---|---|---|---|
| 114447855 | 11444785 | 1 | 20141222 | 0 | ||
| 114447855 | 11444785 | 4 | 20150204 | 0 | ||
| 114447855 | 11444785 | 5 | 201501 | 0 | ||
| 114447855 | 11444785 | 11 | 20160622 | 20160702 | 0 |