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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125970602 | 12597060 | 2 | F | 20160716 | 20160727 | 20160729 | EXP | US-CIPLA LTD.-2016US09917 | CIPLA | 0.00 | Y | 0.00000 | 20160729 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125970602 | 12597060 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 250 MG, BID | U | U | 78234 | 250 | MG | ||||||
| 125970602 | 12597060 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 500 MG, BID | U | U | 78234 | 500 | MG | ||||||
| 125970602 | 12597060 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 750 MG, BID | U | U | 78234 | 750 | MG | ||||||
| 125970602 | 12597060 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125970602 | 12597060 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125970602 | 12597060 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125970602 | 12597060 | Dysuria | |
| 125970602 | 12597060 | Skin discolouration |
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 |
|---|---|---|---|---|---|---|
| 125970602 | 12597060 | 1 | 201605 | 0 |