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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 643121811 | 6431218 | 11 | F | 20080108 | 20160830 | 20071001 | 20160902 | EXP | US-BRISTOL-MYERS SQUIBB COMPANY-13921481 | BRISTOL MYERS SQUIBB | 0.00 | N | F | Y | 2.95000 | KG | 20160902 | OT | ZA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 643121811 | 6431218 | 1 | PS | EFAVIRENZ | EFAVIRENZ | 1 | Transplacental | 600 MG, QD | U | 20972 | 600 | MG | QD | ||||||
| 643121811 | 6431218 | 2 | SS | COMBIVIR | LAMIVUDINEIDOVUDINE | 1 | Transplacental | 2 DF, QD | U | 0 | 2 | DF | QD | ||||||
| 643121811 | 6431218 | 3 | SS | VIRACEPT | NELFINAVIR MESYLATE | 1 | Transplacental | 2500 MG, QD | U | 0 | 2500 | MG | QD | ||||||
| 643121811 | 6431218 | 4 | SS | KALETRA | LOPINAVIRRITONAVIR | 1 | Transplacental | 4 DF, QD | U | 0 | 4 | DF | QD | ||||||
| 643121811 | 6431218 | 5 | SS | RETROVIR | ZIDOVUDINE | 1 | Transplacental | 2 MG/KG, QD | U | 0 | 2 | MG/KG | QD | ||||||
| 643121811 | 6431218 | 6 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Transplacental | U | 0 | ||||||||||
| 643121811 | 6431218 | 7 | SS | INSULIN | INSULIN NOS | 1 | Transplacental | U | 0 | ||||||||||
| 643121811 | 6431218 | 8 | C | FOLATE | FOLATE SODIUM | 1 | Transplacental | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 643121811 | 6431218 | 1 | Product used for unknown indication |
| 643121811 | 6431218 | 2 | Product used for unknown indication |
| 643121811 | 6431218 | 3 | Product used for unknown indication |
| 643121811 | 6431218 | 4 | Product used for unknown indication |
| 643121811 | 6431218 | 5 | Product used for unknown indication |
| 643121811 | 6431218 | 6 | Product used for unknown indication |
| 643121811 | 6431218 | 7 | Product used for unknown indication |
| 643121811 | 6431218 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 643121811 | 6431218 | OT |
| 643121811 | 6431218 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 643121811 | 6431218 | Amniotic band syndrome | |
| 643121811 | 6431218 | Anophthalmos | |
| 643121811 | 6431218 | Cleft lip and palate | |
| 643121811 | 6431218 | Foetal exposure during pregnancy | |
| 643121811 | 6431218 | Neural tube defect | |
| 643121811 | 6431218 | Premature baby |
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 |
|---|---|---|---|---|---|---|
| 643121811 | 6431218 | 1 | 20070627 | 0 | ||
| 643121811 | 6431218 | 2 | 20080108 | 0 | ||
| 643121811 | 6431218 | 3 | 20070627 | 20070627 | 0 | |
| 643121811 | 6431218 | 4 | 20070913 | 20080108 | 0 | |
| 643121811 | 6431218 | 5 | 20080108 | 20080108 | 0 |