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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118548992 | 11854899 | 2 | F | 20120408 | 20160825 | 20151221 | 20160901 | EXP | NG-BRISTOL-MYERS SQUIBB COMPANY-19223064 | BRISTOL MYERS SQUIBB | 0.00 | DY | F | Y | 1.72000 | KG | 20160901 | CN | US | NG |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118548992 | 11854899 | 1 | PS | EFAVIRENZ | EFAVIRENZ | 1 | Transplacental | UNK | 21360 | FILM-COATED TABLET | |||||||||
| 118548992 | 11854899 | 2 | SS | RALTEGRAVIR. | RALTEGRAVIR | 1 | Transplacental | 800 MG, QD | 223200 | MG | Y | 0 | 800 | MG | QD | ||||
| 118548992 | 11854899 | 3 | SS | FORTOVASE | SAQUINAVIR | 1 | Transplacental | 1000 MG, QD | 0 | 1000 | MG | QD | |||||||
| 118548992 | 11854899 | 4 | SS | COMBIVIR | LAMIVUDINEIDOVUDINE | 1 | Transplacental | UNK | U | 0 | |||||||||
| 118548992 | 11854899 | 5 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | UNK | U | 0 | |||||||||
| 118548992 | 11854899 | 6 | SS | LOPINAVIR | LOPINAVIR | 1 | Transplacental | UNK | U | 0 | |||||||||
| 118548992 | 11854899 | 7 | SS | KALETRA | LOPINAVIRRITONAVIR | 1 | Transplacental | UNK | 0 | ||||||||||
| 118548992 | 11854899 | 8 | C | SULFAMETHOXAZOLE-TRIMETHOPRIM (SMZ) | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Transplacental | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118548992 | 11854899 | 1 | Product used for unknown indication |
| 118548992 | 11854899 | 2 | Product used for unknown indication |
| 118548992 | 11854899 | 3 | Product used for unknown indication |
| 118548992 | 11854899 | 4 | Product used for unknown indication |
| 118548992 | 11854899 | 5 | Product used for unknown indication |
| 118548992 | 11854899 | 6 | Product used for unknown indication |
| 118548992 | 11854899 | 7 | Product used for unknown indication |
| 118548992 | 11854899 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118548992 | 11854899 | CA |
| 118548992 | 11854899 | DE |
| 118548992 | 11854899 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118548992 | 11854899 | Congenital hand malformation | |
| 118548992 | 11854899 | Congenital hepatomegaly | |
| 118548992 | 11854899 | Dysmorphism | |
| 118548992 | 11854899 | Foetal exposure during pregnancy | |
| 118548992 | 11854899 | Premature baby | |
| 118548992 | 11854899 | Respiratory distress | |
| 118548992 | 11854899 | Splenomegaly | |
| 118548992 | 11854899 | Talipes | |
| 118548992 | 11854899 | Trisomy 21 |
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 |
|---|---|---|---|---|---|---|
| 118548992 | 11854899 | 1 | 20081205 | 0 | ||
| 118548992 | 11854899 | 2 | 20110304 | 20111207 | 0 | |
| 118548992 | 11854899 | 3 | 20111207 | 0 | ||
| 118548992 | 11854899 | 4 | 20111207 | 0 | ||
| 118548992 | 11854899 | 5 | 20081205 | 0 | ||
| 118548992 | 11854899 | 7 | 20110304 | 0 | ||
| 118548992 | 11854899 | 8 | 20110304 | 0 |