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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109754315 | 10975431 | 5 | F | 201302 | 20160907 | 20150401 | 20160912 | EXP | US-PFIZER INC-2015109197 | PFIZER | 60.00 | YR | F | Y | 75.00000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109754315 | 10975431 | 1 | PS | SIROLIMUS. | SIROLIMUS | 1 | 0.5 MG, DAILY | 21110 | .5 | MG | |||||||||
| 109754315 | 10975431 | 2 | SS | SIROLIMUS. | SIROLIMUS | 1 | Oral | 1 MG, 1X/DAY | 21110 | 1 | MG | QD | |||||||
| 109754315 | 10975431 | 3 | SS | SIROLIMUS. | SIROLIMUS | 1 | Oral | 0.5 MG, 1X/DAY | 21110 | .5 | MG | QD | |||||||
| 109754315 | 10975431 | 4 | SS | SIROLIMUS. | SIROLIMUS | 1 | Oral | 1 MG, 1X/DAY | 21110 | 1 | MG | QD | |||||||
| 109754315 | 10975431 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 109754315 | 10975431 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | 15 MG, UNK | 0 | 15 | MG | |||||||||
| 109754315 | 10975431 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | 20 MG, UNK | 0 | 20 | MG | |||||||||
| 109754315 | 10975431 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, 2X/DAY | 0 | 20 | MG | BID | ||||||||
| 109754315 | 10975431 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 40 MG, 2X/DAY | 0 | 40 | MG | BID | ||||||||
| 109754315 | 10975431 | 10 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 109754315 | 10975431 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 109754315 | 10975431 | 12 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 109754315 | 10975431 | 13 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 10 UNK, UNK | 0 | 10 | MG | |||||||||
| 109754315 | 10975431 | 14 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 20 UNK, UNK | 0 | 20 | MG | |||||||||
| 109754315 | 10975431 | 15 | C | MVI | VITAMINS | 1 | UNK | 0 | |||||||||||
| 109754315 | 10975431 | 16 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | 400 IU, UNK | 0 | 400 | IU | |||||||||
| 109754315 | 10975431 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 4000 MG, UNK | 0 | 4000 | MG | |||||||||
| 109754315 | 10975431 | 18 | C | Ester C | 2 | 1000 MG, UNK | 0 | 1000 | MG | ||||||||||
| 109754315 | 10975431 | 19 | C | ASA | ASPIRIN | 1 | 81 ?G, UNK | 0 | 81 | UG | |||||||||
| 109754315 | 10975431 | 20 | C | Timoptic Ocudose | 2 | (0.5 % EVERY OTHER DAY EVERY OTHER EYE) | 0 | ||||||||||||
| 109754315 | 10975431 | 21 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | 5 MG, UNK | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109754315 | 10975431 | 1 | Lymphangioleiomyomatosis |
| 109754315 | 10975431 | 5 | Blood pressure abnormal |
| 109754315 | 10975431 | 11 | Blood cholesterol |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109754315 | 10975431 | HO |
| 109754315 | 10975431 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109754315 | 10975431 | Anal incontinence | |
| 109754315 | 10975431 | Blood cholesterol increased | |
| 109754315 | 10975431 | Chills | |
| 109754315 | 10975431 | Diarrhoea | |
| 109754315 | 10975431 | Drug ineffective for unapproved indication | |
| 109754315 | 10975431 | Fatigue | |
| 109754315 | 10975431 | Gastrooesophageal reflux disease | |
| 109754315 | 10975431 | Glaucoma | |
| 109754315 | 10975431 | Headache | |
| 109754315 | 10975431 | Hypertension | |
| 109754315 | 10975431 | Intraocular pressure increased | |
| 109754315 | 10975431 | Malaise | |
| 109754315 | 10975431 | Peripheral swelling | |
| 109754315 | 10975431 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 109754315 | 10975431 | 1 | 201302 | 0 | ||
| 109754315 | 10975431 | 2 | 20150105 | 0 | ||
| 109754315 | 10975431 | 3 | 201503 | 0 | ||
| 109754315 | 10975431 | 4 | 20160705 | 0 | ||
| 109754315 | 10975431 | 5 | 201405 | 0 | ||
| 109754315 | 10975431 | 11 | 2015 | 0 | ||
| 109754315 | 10975431 | 14 | 20160526 | 20160701 | 0 | |
| 109754315 | 10975431 | 21 | 201503 | 20160526 | 0 |