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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127835221 | 12783522 | 1 | I | 20160916 | 20160927 | 20160927 | EXP | CN-CIPLA LTD.-2016US18591 | CIPLA | PAN CQ, DUAN Z, DAI E, ZHANG S, HAN G, WANG Y, ET AL.,. TENOFOVIR TO PREVENT HEPATITIS B TRANSMISSION IN MOTHERS WITH HIGH VIRAL LOAD. THE NEW ENGLAND JOURNAL OF MEDICINE. 2016;374 (24):2324 TO 2334 | 0.00 | Y | 0.00000 | 20160927 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127835221 | 12783522 | 1 | PS | Tenofovir | TENOFOVIR | 1 | Oral | 300 MG, DAILY | U | U | 78800 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127835221 | 12783522 | 1 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127835221 | 12783522 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127835221 | 12783522 | Abdominal pain lower | |
| 127835221 | 12783522 | Exposure during pregnancy | |
| 127835221 | 12783522 | Jaundice | |
| 127835221 | 12783522 | Pruritus | |
| 127835221 | 12783522 | Stillbirth |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |