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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117810049 | 11781004 | 9 | F | 20150213 | 20160803 | 20151126 | 20160805 | PER | PHEH2015US003320 | NOVARTIS | 26.59 | YR | M | Y | 0.00000 | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117810049 | 11781004 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | TABLET | QD | |||||
| 117810049 | 11781004 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, EVERY OTHER DAY | Y | 22334 | 5 | MG | TABLET | ||||||
| 117810049 | 11781004 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD (DAILY) | Y | 22334 | 2.5 | MG | TABLET | QD | |||||
| 117810049 | 11781004 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | Y | 22334 | 2.5 | MG | TABLET | QD | |||||
| 117810049 | 11781004 | 5 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | UNK UKN, PRN | U | 0 | |||||||||
| 117810049 | 11781004 | 6 | C | RISPERDAL | RISPERIDONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 117810049 | 11781004 | 7 | C | BENZOTROPINE | BENZTROPINE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 8 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 9 | C | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 10 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 11 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 12 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | UNK UKN, PRN | U | 0 | CREAM | ||||||||
| 117810049 | 11781004 | 13 | C | L-LYSINE | LYSINE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 14 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 15 | C | DRONABINOL. | DRONABINOL | 1 | Unknown | Y | 0 | ||||||||||
| 117810049 | 11781004 | 16 | C | BUPROPION. | BUPROPION | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 17 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | U | 0 | ||||||||||
| 117810049 | 11781004 | 18 | C | GUANFACINE. | GUANFACINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117810049 | 11781004 | 1 | Ganglioglioma |
| 117810049 | 11781004 | 2 | Astrocytoma, low grade |
| 117810049 | 11781004 | 5 | Product used for unknown indication |
| 117810049 | 11781004 | 6 | Product used for unknown indication |
| 117810049 | 11781004 | 7 | Product used for unknown indication |
| 117810049 | 11781004 | 8 | Product used for unknown indication |
| 117810049 | 11781004 | 9 | Product used for unknown indication |
| 117810049 | 11781004 | 10 | Product used for unknown indication |
| 117810049 | 11781004 | 11 | Product used for unknown indication |
| 117810049 | 11781004 | 12 | Product used for unknown indication |
| 117810049 | 11781004 | 13 | Product used for unknown indication |
| 117810049 | 11781004 | 14 | Product used for unknown indication |
| 117810049 | 11781004 | 15 | Product used for unknown indication |
| 117810049 | 11781004 | 16 | Product used for unknown indication |
| 117810049 | 11781004 | 17 | Product used for unknown indication |
| 117810049 | 11781004 | 18 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117810049 | 11781004 | Abnormal behaviour | |
| 117810049 | 11781004 | Anger | |
| 117810049 | 11781004 | Cholelithiasis | |
| 117810049 | 11781004 | Glossodynia | |
| 117810049 | 11781004 | Joint swelling | |
| 117810049 | 11781004 | Limb mass | |
| 117810049 | 11781004 | Mood altered | |
| 117810049 | 11781004 | Mouth ulceration | |
| 117810049 | 11781004 | Oral herpes | |
| 117810049 | 11781004 | Oral pain | |
| 117810049 | 11781004 | Peripheral swelling | |
| 117810049 | 11781004 | Weight 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 |
|---|---|---|---|---|---|---|
| 117810049 | 11781004 | 1 | 20140710 | 0 | ||
| 117810049 | 11781004 | 2 | 20150226 | 0 | ||
| 117810049 | 11781004 | 3 | 20150427 | 0 | ||
| 117810049 | 11781004 | 4 | 201605 | 0 | ||
| 117810049 | 11781004 | 14 | 201503 | 0 |