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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118331643 | 11833164 | 3 | F | 20151204 | 20151214 | 20160714 | EXP | PHHY2015DE160176 | SANDOZ | SCHONFELD C-L, FISCHER M, DISTELMAIER P, PHILIPP S, PAQUET P, HALLER K, ET AL.. RECOVERY OF VISUAL FUNCTION AFTER ADMINISTRATION OF DABIGATRAN ETEXILATE. CASE-REP-OPHTHA. 2014;5(2):262-266 | 46.00 | YR | F | Y | 0.00000 | 20160714 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118331643 | 11833164 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 100 MG, QD (FOR 3 DAYS) | 80339 | 100 | MG | QD | |||||||
| 118331643 | 11833164 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 80 MG, QD (FOR 3 DAYS) | 80339 | 80 | MG | QD | |||||||
| 118331643 | 11833164 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 60 MG, QD (FOR 3 DAYS) | 80339 | 60 | MG | QD | |||||||
| 118331643 | 11833164 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 40 MG, QD (FOR 3 DAYS) | 80339 | 40 | MG | QD | |||||||
| 118331643 | 11833164 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 20 MG, QD (FOR 3 DAYS) | 80339 | 20 | MG | QD | |||||||
| 118331643 | 11833164 | 6 | SS | ACETYLSALICYLIC ACID | ASPIRIN | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118331643 | 11833164 | 1 | Pupillary reflex impaired |
| 118331643 | 11833164 | 6 | Pupillary reflex impaired |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118331643 | 11833164 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118331643 | 11833164 | Hyperhidrosis | |
| 118331643 | 11833164 | Insomnia | |
| 118331643 | 11833164 | Restlessness | |
| 118331643 | 11833164 | Swelling face | |
| 118331643 | 11833164 | Tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |