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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125784021 | 12578402 | 1 | I | 20160628 | 20160707 | 20160721 | 20160721 | EXP | DE-AUROBINDO-AUR-APL-2016-09578 | AUROBINDO | 7.00 | YR | M | Y | 25.40000 | KG | 20160721 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125784021 | 12578402 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | 0.25 MG, DAILY | Y | U | 78269 | .25 | MG | |||||||
| 125784021 | 12578402 | 2 | SS | ELVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 10 MG, DAILY | Y | U | 3135845D | 0 | 10 | MG | |||||
| 125784021 | 12578402 | 3 | SS | ELVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, DAILY | Y | U | 0 | 20 | MG | ||||||
| 125784021 | 12578402 | 4 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125784021 | 12578402 | 1 | Product used for unknown indication |
| 125784021 | 12578402 | 2 | Product used for unknown indication |
| 125784021 | 12578402 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125784021 | 12578402 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125784021 | 12578402 | Dyskinesia | |
| 125784021 | 12578402 | Eating disorder | |
| 125784021 | 12578402 | Initial insomnia | |
| 125784021 | 12578402 | Restlessness | |
| 125784021 | 12578402 | Speech disorder | |
| 125784021 | 12578402 | Tongue disorder |
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 |
|---|---|---|---|---|---|---|
| 125784021 | 12578402 | 1 | 20160624 | 0 | ||
| 125784021 | 12578402 | 2 | 20160625 | 20160626 | 0 | |
| 125784021 | 12578402 | 3 | 20160627 | 20160628 | 0 | |
| 125784021 | 12578402 | 4 | 20160628 | 0 |