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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125025942 | 12502594 | 2 | F | 20160130 | 20160818 | 20160627 | 20160831 | EXP | US-SHIRE-US201607216 | SHIRE | 59.30 | YR | M | Y | 68.27000 | KG | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125025942 | 12502594 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 1000 MG (TWO 500 MG), 3X/DAY:TID | 363000 | MG | Y | AF1814A | 20049 | 1000 | MG | CAPSULE | TID | ||
| 125025942 | 12502594 | 2 | SS | PENTASA | MESALAMINE | 1 | Oral | 500 MG, UNKNOWN | 363000 | MG | Y | 20049 | 500 | MG | CAPSULE | ||||
| 125025942 | 12502594 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK, UNKNOWN | 0 | ||||||||||
| 125025942 | 12502594 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, 3X/DAY:TID | 0 | 10 | MG | TID | |||||||
| 125025942 | 12502594 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, 1X/DAY:QD | 0 | 10 | MG | QD | |||||||
| 125025942 | 12502594 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 30 MG, UNKNOWN | 0 | 30 | MG | ||||||||
| 125025942 | 12502594 | 7 | C | CIALIS | TADALAFIL | 1 | Unknown | 10 MG, AS REQ'D | 0 | 10 | MG | ||||||||
| 125025942 | 12502594 | 8 | C | VIAGRA | SILDENAFIL CITRATE | 1 | Unknown | UNK, UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125025942 | 12502594 | 1 | Colitis ulcerative |
| 125025942 | 12502594 | 2 | Crohn's disease |
| 125025942 | 12502594 | 3 | Colitis ulcerative |
| 125025942 | 12502594 | 4 | Crohn's disease |
| 125025942 | 12502594 | 7 | Erectile dysfunction |
| 125025942 | 12502594 | 8 | Erectile dysfunction |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125025942 | 12502594 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125025942 | 12502594 | Abnormal loss of weight | |
| 125025942 | 12502594 | Colitis ulcerative | |
| 125025942 | 12502594 | Contusion | |
| 125025942 | 12502594 | Crohn's disease | |
| 125025942 | 12502594 | Drug ineffective | |
| 125025942 | 12502594 | Feeling hot | |
| 125025942 | 12502594 | Hypoaesthesia | |
| 125025942 | 12502594 | Pain in extremity | |
| 125025942 | 12502594 | Peripheral swelling | |
| 125025942 | 12502594 | Platelet aggregation |
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 |
|---|---|---|---|---|---|---|
| 125025942 | 12502594 | 1 | 20160130 | 2016 | 0 | |
| 125025942 | 12502594 | 2 | 20160202 | 20160606 | 0 | |
| 125025942 | 12502594 | 3 | 201601 | 20160202 | 0 | |
| 125025942 | 12502594 | 4 | 20160601 | 201606 | 0 | |
| 125025942 | 12502594 | 5 | 201606 | 201606 | 0 | |
| 125025942 | 12502594 | 7 | 201603 | 0 |