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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127304271 | 12730427 | 1 | I | 20160906 | 20160909 | 20160909 | EXP | IT-ABBVIE-16P-083-1723134-00 | ABBVIE | FLORIDIA M, MASTROIACOVO P, TAMBURRINI E, ET AL. ITALIAN GROUP ON SURVEILLANCE ON ANTIRETROVIRAL TREATMENT IN PREGNANCY. BIRTH DEFECTS IN A NATIONAL COHORT OF PREGNANT WOMEN WITH HIV INFECTION IN ITALY. BJOG. 2013;120 (12):1466-1475. | 0.00 | Y | 0.00000 | 20160909 | OT | COUNTRY NOT SPECIFIED | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127304271 | 12730427 | 1 | PS | LOPINAVIR/RITONAVIR | LOPINAVIRRITONAVIR | 1 | Transplacental | UNKNOWN | 21906 | ||||||||||
| 127304271 | 12730427 | 2 | SS | TENOFOVIR | TENOFOVIR | 1 | Transplacental | 0 | |||||||||||
| 127304271 | 12730427 | 3 | SS | EMTRICITABINE | EMTRICITABINE | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127304271 | 12730427 | 1 | Maternal exposure timing unspecified |
| 127304271 | 12730427 | 2 | Maternal exposure timing unspecified |
| 127304271 | 12730427 | 3 | Maternal exposure timing unspecified |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127304271 | 12730427 | CA |
| 127304271 | 12730427 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127304271 | 12730427 | Cardiomegaly | |
| 127304271 | 12730427 | Foetal death | |
| 127304271 | 12730427 | Foetal exposure during pregnancy | |
| 127304271 | 12730427 | Ventricular septal defect |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |