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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127896301 | 12789630 | 1 | I | 2010 | 20160922 | 20160928 | 20160928 | EXP | BR-ABBVIE-16P-020-1739852-00 | ABBVIE | 0.00 | F | Y | 0.00000 | 20160928 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127896301 | 12789630 | 1 | PS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | DAILY DOSE: 250 MG; AT NIGHT | D | UNKNOWN | 18723 | 250 | MG | TABLET | QD | ||||
| 127896301 | 12789630 | 2 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | DAILY DOSE: 500 MG; MORNING/NIGHT | D | UNKNOWN | 18723 | 250 | MG | BID | |||||
| 127896301 | 12789630 | 3 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | D | UNKNOWN | 18723 | |||||||||
| 127896301 | 12789630 | 4 | SS | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | Oral | DAILY DOSE: 250 MG; AT NIGHT | D | UNKNOWN,1010668 | 21168 | 250 | MG | QD | |||||
| 127896301 | 12789630 | 5 | SS | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | Oral | DAILY DOSE: 500 MG; AT NIGHT | D | UNKNOWN,1010668 | 21168 | 500 | MG | QD | |||||
| 127896301 | 12789630 | 6 | SS | OLCADIL | CLOXAZOLAM | 1 | Oral | DAILY DOSE: 3 MG; HALF TABLET IN THE MORNING AND ONE TABLET AT NIGHT | D | UNKNOWN | 0 | BID | |||||||
| 127896301 | 12789630 | 7 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | DAILY DOSE: 20 MG; AT NIGHT | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127896301 | 12789630 | 1 | Affective disorder |
| 127896301 | 12789630 | 4 | Affective disorder |
| 127896301 | 12789630 | 6 | Product used for unknown indication |
| 127896301 | 12789630 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127896301 | 12789630 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127896301 | 12789630 | Abortion | |
| 127896301 | 12789630 | Anxiety | |
| 127896301 | 12789630 | Fear | |
| 127896301 | 12789630 | Foetal death | |
| 127896301 | 12789630 | Insomnia | |
| 127896301 | 12789630 | Maternal exposure during pregnancy | |
| 127896301 | 12789630 | Nervousness | |
| 127896301 | 12789630 | Panic reaction |
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 |
|---|---|---|---|---|---|---|
| 127896301 | 12789630 | 1 | 2008 | 2010 | 0 | |
| 127896301 | 12789630 | 2 | 2010 | 2011 | 0 | |
| 127896301 | 12789630 | 5 | 201606 | 0 | ||
| 127896301 | 12789630 | 6 | 2012 | 0 | ||
| 127896301 | 12789630 | 7 | 2010 | 2012 | 0 |