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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127597682 | 12759768 | 2 | F | 20160917 | 20160919 | 20160924 | EXP | PHHY2016US128692 | SANDOZ | DAS BB, RAKHEJA D, LACELLE C, SEDLAK RH, GULVE N, GULVE SR ET AL.. POSSIBLE PROGESTERONE-INDUCED GESTATIONAL ACTIVATION OF CHROMOSOMALLY INTEGRATED HUMAN HERPESVIRUS 6B AND TRANSPLACENTAL TRANSMISSION OF ACTIVATED HUMAN HERPESVIRUS 6B. JOURNAL OF HEART AND LUNG TRANSPLANTATION. 2016;1-4 | 4.00 | DY | M | Y | 0.00000 | 20160924 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127597682 | 12759768 | 1 | SS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | D | 0 | ||||||||||
| 127597682 | 12759768 | 2 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | D | 77713 | ||||||||||
| 127597682 | 12759768 | 3 | SS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Transplacental | D | 0 | ||||||||||
| 127597682 | 12759768 | 4 | SS | PROGESTERONE. | PROGESTERONE | 1 | Transplacental | MATERNAL DOSE: HIGH DSOE | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127597682 | 12759768 | 1 | Foetal exposure during pregnancy |
| 127597682 | 12759768 | 2 | Foetal exposure during pregnancy |
| 127597682 | 12759768 | 3 | Foetal exposure during pregnancy |
| 127597682 | 12759768 | 4 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127597682 | 12759768 | CA |
| 127597682 | 12759768 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127597682 | 12759768 | Cardiac failure | |
| 127597682 | 12759768 | Congestive cardiomyopathy | |
| 127597682 | 12759768 | Foetal exposure during pregnancy | |
| 127597682 | 12759768 | Multiple organ dysfunction syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |