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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125289471 | 12528947 | 1 | I | 2015 | 20160628 | 20160705 | 20160705 | EXP | US-JNJFOC-20160627118 | JANSSEN | 0.00 | A | F | Y | 0.00000 | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125289471 | 12528947 | 1 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | U | U | 21121 | SUSTAINED RELEASE TABLETS | ||||||||
| 125289471 | 12528947 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | UNKNOWN | 0 | 100 | MG | TABLET | ||||||
| 125289471 | 12528947 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | UNKNOWN | 0 | 200 | MG | TABLET | ||||||
| 125289471 | 12528947 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | UNKNOWN | 0 | 100 | MG | TABLET | ||||||
| 125289471 | 12528947 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | UNKNOWN | 0 | 200 | MG | TABLET | ||||||
| 125289471 | 12528947 | 6 | SS | TREXIMET | NAPROXEN SODIUMSUMATRIPTAN SUCCINATE | 1 | Unknown | U | 0 | 85 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125289471 | 12528947 | 1 | Attention deficit/hyperactivity disorder |
| 125289471 | 12528947 | 2 | Depression |
| 125289471 | 12528947 | 3 | Depression |
| 125289471 | 12528947 | 4 | Bipolar disorder |
| 125289471 | 12528947 | 5 | Bipolar disorder |
| 125289471 | 12528947 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125289471 | 12528947 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125289471 | 12528947 | Anxiety | |
| 125289471 | 12528947 | Drug dose omission | |
| 125289471 | 12528947 | Gallbladder operation | |
| 125289471 | 12528947 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125289471 | 12528947 | 2 | 20111207 | 0 | ||
| 125289471 | 12528947 | 3 | 20120126 | 0 | ||
| 125289471 | 12528947 | 4 | 20111207 | 0 | ||
| 125289471 | 12528947 | 5 | 20120126 | 0 | ||
| 125289471 | 12528947 | 6 | 20121010 | 0 |