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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779801 | 12677980 | 1 | I | 20160816 | 20160823 | 20160823 | EXP | CN-JNJFOC-20160814059 | JANSSEN | JIANG P, MEI Q, SHEN J. COMPARATIVE STUDY OF ANTIEPILEPTICS IN THE TREATMENT OF MANIC EPISODE. JOURNAL OF NEUROSCIENCE AND MENTAL HEALTH 2010;10/6:586-588. | 0.00 | Y | 0.00000 | 20160823 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779801 | 12677980 | 1 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | STRENGTH: 50 TO 200 MG ??EIGHT WEEKS | U | U | 0 | TABLETS | |||||||
| 126779801 | 12677980 | 2 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | STRENGTH: 25MG ONE AT NOON AND ONE IN EVENING | U | U | 20505 | 25 | MG | TABLETS | BID | ||||
| 126779801 | 12677980 | 3 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | ONCE AT NON AND ONE IN THE EVENING | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126779801 | 12677980 | 1 | Bipolar I disorder |
| 126779801 | 12677980 | 2 | Bipolar I disorder |
| 126779801 | 12677980 | 3 | Bipolar I disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126779801 | 12677980 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126779801 | 12677980 | Decreased appetite | |
| 126779801 | 12677980 | Electrocardiogram ST-T change | |
| 126779801 | 12677980 | Hypoaesthesia | |
| 126779801 | 12677980 | Nausea | |
| 126779801 | 12677980 | Off label use | |
| 126779801 | 12677980 | Product use issue | |
| 126779801 | 12677980 | Tachycardia | |
| 126779801 | 12677980 | Vomiting | |
| 126779801 | 12677980 | Weight decreased | |
| 126779801 | 12677980 | Weight increased | |
| 126779801 | 12677980 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |