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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 38397925 | 3839792 | 5 | F | 20020710 | 20160824 | 20020918 | 20160825 | EXP | US-BRISTOL-MYERS SQUIBB COMPANY-12035572 | BRISTOL MYERS SQUIBB | 0.00 | DY | F | Y | 2.50000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 38397925 | 3839792 | 1 | PS | EFAVIRENZ | EFAVIRENZ | 1 | Transplacental | 600 MG, QD | 20972 | 600 | MG | CAPSULE | QD | ||||||
| 38397925 | 3839792 | 2 | SS | COMBIVIR | LAMIVUDINEIDOVUDINE | 1 | Transplacental | 2 DF, QD | 0 | 2 | DF | QD | |||||||
| 38397925 | 3839792 | 3 | SS | TRIZIVIR | ABACAVIR SULFATELAMIVUDINEIDOVUDINE | 1 | Transplacental | 2 DF, QD | U | 0 | 2 | DF | QD | ||||||
| 38397925 | 3839792 | 4 | SS | TENOFOVIR | TENOFOVIR | 1 | Transplacental | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 38397925 | 3839792 | 5 | SS | RETROVIR | ZIDOVUDINE | 1 | Transplacental | 643 MG, QD | U | 0 | 643 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 38397925 | 3839792 | 1 | Product used for unknown indication |
| 38397925 | 3839792 | 2 | Product used for unknown indication |
| 38397925 | 3839792 | 3 | Product used for unknown indication |
| 38397925 | 3839792 | 4 | Product used for unknown indication |
| 38397925 | 3839792 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 38397925 | 3839792 | OT |
| 38397925 | 3839792 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 38397925 | 3839792 | Cleft palate | |
| 38397925 | 3839792 | Foetal exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 38397925 | 3839792 | 1 | 20020114 | 0 | ||
| 38397925 | 3839792 | 2 | 20020215 | 0 | ||
| 38397925 | 3839792 | 3 | 20020218 | 20020710 | 0 | |
| 38397925 | 3839792 | 4 | 20020218 | 20020710 | 0 | |
| 38397925 | 3839792 | 5 | 20020710 | 20020710 | 0 |