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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351093 | 12635109 | 3 | F | 20160624 | 20160822 | 20160808 | 20160825 | EXP | US-ABBVIE-16P-163-1692819-00 | ABBVIE | 0.00 | Y | 0.00000 | 20160825 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351093 | 12635109 | 1 | PS | KALETRA | LOPINAVIRRITONAVIR | 1 | Transplacental | 21226 | SOFT CAPSULE | ||||||||||
| 126351093 | 12635109 | 2 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 126351093 | 12635109 | 3 | C | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 126351093 | 12635109 | 4 | C | DOCQLACE | DOCUSATE SODIUM | 1 | Transplacental | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126351093 | 12635109 | 1 | Maternal exposure timing unspecified |
| 126351093 | 12635109 | 2 | Maternal exposure timing unspecified |
| 126351093 | 12635109 | 3 | Maternal exposure timing unspecified |
| 126351093 | 12635109 | 4 | Maternal exposure timing unspecified |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126351093 | 12635109 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126351093 | 12635109 | Foetal exposure during pregnancy | |
| 126351093 | 12635109 | Microtia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |