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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96127729 | 9612772 | 9 | F | 20120929 | 20130819 | 20131010 | 20160822 | EXP | PHHY2013US113070 | NOVARTIS | 0.00 | DY | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96127729 | 9612772 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Transplacental | MATERNAL DOSE: 0.5 MG, QD | 22527 | CAPSULE | |||||||||
| 96127729 | 9612772 | 2 | C | KEPPRA | LEVETIRACETAM | 1 | Transplacental | MATERNAL DOSE: 1000 MG | 0 | ||||||||||
| 96127729 | 9612772 | 3 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Transplacental | MATERNAL DOSE | 0 | ||||||||||
| 96127729 | 9612772 | 4 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Transplacental | MATERNAL DOSE | 0 | ||||||||||
| 96127729 | 9612772 | 5 | C | GABAPENTIN. | GABAPENTIN | 1 | Transplacental | MATERNAL DOSE | 0 | ||||||||||
| 96127729 | 9612772 | 6 | C | ADIPEX-P | PHENTERMINE HYDROCHLORIDE | 1 | Transplacental | MATERNAL DOSE | 0 | ||||||||||
| 96127729 | 9612772 | 7 | C | ATIVAN | LORAZEPAM | 1 | Transplacental | MATERNAL DOSE | 0 | ||||||||||
| 96127729 | 9612772 | 8 | C | DOXYCLINE ^KALBE FARMA^ | 2 | Transplacental | MATERNAL DOSE | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96127729 | 9612772 | 1 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 2 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 3 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 4 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 5 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 6 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 7 | Foetal exposure during pregnancy |
| 96127729 | 9612772 | 8 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96127729 | 9612772 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96127729 | 9612772 | Blood pressure decreased | |
| 96127729 | 9612772 | Foetal exposure during pregnancy | |
| 96127729 | 9612772 | Gastrooesophageal reflux disease | |
| 96127729 | 9612772 | Heart rate decreased | |
| 96127729 | 9612772 | Talipes |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |