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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117345112 | 11734511 | 2 | F | 20100406 | 20160822 | 20151113 | 20160830 | EXP | FR-009507513-1010USA01114B1 | MERCK | 1.00 | DY | F | Y | 1.69000 | KG | 20160830 | CN | US | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117345112 | 11734511 | 1 | SS | SUSTIVA | EFAVIRENZ | 1 | Transplacental | COURSE 1 | Y | U | 0 | CAPSULE | |||||||
| 117345112 | 11734511 | 2 | PS | CELESTENE | BETAMETHASONE | 1 | Transplacental | DURING THE 2ND AND THE 3RD TRIMESTER OF PREGNANCY | U | U | 14215 | DISPERSIBLE TABLET | |||||||
| 117345112 | 11734511 | 3 | SS | REYATAZ | ATAZANAVIR SULFATE | 1 | Transplacental | UNK | U | U | 0 | ||||||||
| 117345112 | 11734511 | 4 | SS | ZIAGEN | ABACAVIR SULFATE | 1 | Transplacental | COURSE 1 | Y | U | 0 | ||||||||
| 117345112 | 11734511 | 5 | SS | ZIAGEN | ABACAVIR SULFATE | 1 | Transplacental | COURSE 2 | Y | U | 0 | ||||||||
| 117345112 | 11734511 | 6 | SS | NORVIR | RITONAVIR | 1 | Transplacental | UNK | U | U | 0 | ||||||||
| 117345112 | 11734511 | 7 | SS | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | COURSE 1 | Y | U | 0 | ||||||||
| 117345112 | 11734511 | 8 | SS | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 1 | COURSE 2 | Y | U | 0 | |||||||||
| 117345112 | 11734511 | 9 | SS | RETROVIR | ZIDOVUDINE | 1 | Transplacental | U | U | 0 | |||||||||
| 117345112 | 11734511 | 10 | SS | MICARDIS PLUS | HYDROCHLOROTHIAZIDETELMISARTAN | 1 | Transplacental | DURING THE 2ND AND 3RD TRIMESTER OF PREGNANCY | U | U | 0 | ||||||||
| 117345112 | 11734511 | 11 | SS | SPASFON | PHLOROGLUCINOL | 1 | Transplacental | DURING THE 2ND AND 3RD TRIMESTER OF PREGNANCY | U | U | 0 | ||||||||
| 117345112 | 11734511 | 12 | SS | CLAMOXYL | AMOXICILLINCLAVULANIC ACID | 1 | Transplacental | DURING THE 2ND AND 3RD TRIMESTER OF PREGNANCY | U | U | 0 | ||||||||
| 117345112 | 11734511 | 13 | SS | LOXEN | NICARDIPINE HYDROCHLORIDE | 1 | Transplacental | DURING THE 2ND AND 3RD TRIMESTER OF PREGNANCY | U | U | 0 | ||||||||
| 117345112 | 11734511 | 14 | SS | VITAMIN D | CHOLECALCIFEROL | 1 | Transplacental | DURING THE 3RD TRIMESTER OF PREGNANCY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117345112 | 11734511 | 1 | Product used for unknown indication |
| 117345112 | 11734511 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117345112 | 11734511 | CA |
| 117345112 | 11734511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117345112 | 11734511 | Cardiomegaly | |
| 117345112 | 11734511 | Congenital pulmonary valve atresia | |
| 117345112 | 11734511 | Congenital tricuspid valve atresia | |
| 117345112 | 11734511 | Foetal exposure during pregnancy | |
| 117345112 | 11734511 | Neonatal respiratory distress syndrome | |
| 117345112 | 11734511 | Premature baby | |
| 117345112 | 11734511 | Ventricular hypoplasia |
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 |
|---|---|---|---|---|---|---|
| 117345112 | 11734511 | 1 | 20091001 | 0 | ||
| 117345112 | 11734511 | 3 | 20091119 | 20100406 | 0 | |
| 117345112 | 11734511 | 4 | 20091001 | 0 | ||
| 117345112 | 11734511 | 5 | 20091119 | 20100406 | 0 | |
| 117345112 | 11734511 | 6 | 20091119 | 20100406 | 0 | |
| 117345112 | 11734511 | 7 | 20091001 | 0 | ||
| 117345112 | 11734511 | 8 | 20091119 | 20100406 | 0 | |
| 117345112 | 11734511 | 9 | 20100406 | 20100406 | 0 | |
| 117345112 | 11734511 | 14 | 201002 | 0 |