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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834996 | 11883499 | 6 | F | 2014 | 20160629 | 20151231 | 20160711 | EXP | PHHY2014BR136159 | NOVARTIS | 49.59 | YR | F | Y | 79.00000 | KG | 20160711 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834996 | 11883499 | 1 | PS | SANDOSTATIN LAR DEPOT | OCTREOTIDE ACETATE | 1 | Intramuscular | 30 MG, QMO/EVERY 28 DAYS | Y | 21008 | 30 | MG | |||||||
| 118834996 | 11883499 | 2 | SS | SANDOSTATIN LAR DEPOT | OCTREOTIDE ACETATE | 1 | Intramuscular | (30 MG AND 10 MG, ONE AMPOULE EACH), QMO | Y | S0253 / S0046 | 21008 | 40 | MG | /month | |||||
| 118834996 | 11883499 | 3 | SS | SANDOSTATIN LAR DEPOT | OCTREOTIDE ACETATE | 1 | Intramuscular | 30 MG, QMO | Y | 21008 | 30 | MG | /month | ||||||
| 118834996 | 11883499 | 4 | SS | SANDOSTATIN | OCTREOTIDE ACETATE | 1 | Subcutaneous | 2 DF, Q8H | Y | 0 | 2 | DF | Q8H | ||||||
| 118834996 | 11883499 | 5 | SS | SOMAVERT | PEGVISOMANT | 1 | Subcutaneous | 10 MG, QD | 0 | 10 | MG | INJECTION | QD | ||||||
| 118834996 | 11883499 | 6 | SS | PREDNISONA | PREDNISONE | 1 | Unknown | UNK | Y | 0 | TABLET | ||||||||
| 118834996 | 11883499 | 7 | SS | PREDSIM | PREDNISOLONE | 1 | Oral | 1.5 MG, IN THE SYRINGE AFTER BREAKFAST | 0 | 1.5 | ML | QD | |||||||
| 118834996 | 11883499 | 8 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 400 MG, QW | 0 | 400 | MG | TABLET | /wk | ||||||
| 118834996 | 11883499 | 9 | C | LEVOTIROXINA | LEVOTHYROXINE SODIUM | 1 | Oral | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 118834996 | 11883499 | 10 | C | ESOMEPRAZOL +PHARMA | 2 | Unknown | 1 DF, QD | 0 | 1 | DF | CAPSULE | QD | |||||||
| 118834996 | 11883499 | 11 | C | SINVASTATINA | SIMVASTATIN | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 118834996 | 11883499 | 12 | C | SANDRENA | ESTRADIOL | 1 | Unknown | 1 MG, IN THE BELLY FOOD | 0 | 1 | MG | GEL | |||||||
| 118834996 | 11883499 | 13 | C | OMEPRAZOL | OMEPRAZOLE | 1 | Unknown | OT, QD | U | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118834996 | 11883499 | 1 | Acromegaly |
| 118834996 | 11883499 | 4 | Acromegaly |
| 118834996 | 11883499 | 5 | Product used for unknown indication |
| 118834996 | 11883499 | 6 | Product used for unknown indication |
| 118834996 | 11883499 | 7 | Product used for unknown indication |
| 118834996 | 11883499 | 8 | Onychomycosis |
| 118834996 | 11883499 | 9 | Thyroid hormone replacement therapy |
| 118834996 | 11883499 | 10 | Gastric disorder |
| 118834996 | 11883499 | 11 | Blood cholesterol abnormal |
| 118834996 | 11883499 | 12 | Hormone replacement therapy |
| 118834996 | 11883499 | 13 | Gastric disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118834996 | 11883499 | OT |
| 118834996 | 11883499 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118834996 | 11883499 | Abdominal discomfort | |
| 118834996 | 11883499 | Agitation | |
| 118834996 | 11883499 | Amnesia | |
| 118834996 | 11883499 | Asthenia | |
| 118834996 | 11883499 | Blood cholesterol increased | |
| 118834996 | 11883499 | Blood glucose increased | |
| 118834996 | 11883499 | Body height increased | |
| 118834996 | 11883499 | Central obesity | |
| 118834996 | 11883499 | Drug ineffective | |
| 118834996 | 11883499 | Gait disturbance | |
| 118834996 | 11883499 | Injection site bruising | |
| 118834996 | 11883499 | Injection site discomfort | |
| 118834996 | 11883499 | Injection site pain | |
| 118834996 | 11883499 | Injection site vesicles | |
| 118834996 | 11883499 | Malaise | |
| 118834996 | 11883499 | Needle issue | |
| 118834996 | 11883499 | Nervousness | |
| 118834996 | 11883499 | Swelling | |
| 118834996 | 11883499 | Syncope | |
| 118834996 | 11883499 | 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 |
|---|---|---|---|---|---|---|
| 118834996 | 11883499 | 1 | 2003 | 0 | ||
| 118834996 | 11883499 | 3 | 201511 | 0 | ||
| 118834996 | 11883499 | 4 | 2001 | 0 |