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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223101 | 12522310 | 1 | I | 20160621 | 20160701 | 20160701 | EXP | US-JNJFOC-20160623256 | JANSSEN | TRAN AH, BEST BM, STEK A, WANG J, CAPPARELLI EV, BURCHETT SK, ET AL. PHARMACOKINETICS OF RILPIVIRINE IN HIV-INFECTED PREGNANT WOMEN. J ACQUIR IMMUNE DEFIC SYNDR 2016;72:289-296. | 0.00 | I | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223101 | 12522310 | 1 | PS | RILPIVIRINE | RILPIVIRINE | 1 | Transplacental | N | 202022 | 25 | MG | TABLETS | |||||||
| 125223101 | 12522310 | 2 | SS | DARUNAVIR | DARUNAVIR | 1 | Transplacental | N | 21976 | TABLETS | |||||||||
| 125223101 | 12522310 | 3 | SS | EMTRICITABINE | EMTRICITABINE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 125223101 | 12522310 | 4 | SS | TENOFOVIR DISOPROXIL FUMARATE. | TENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 125223101 | 12522310 | 5 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Transplacental | 0 | UNSPECIFIED | ||||||||||
| 125223101 | 12522310 | 6 | SS | RITONAVIR. | RITONAVIR | 1 | Transplacental | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125223101 | 12522310 | 1 | HIV infection |
| 125223101 | 12522310 | 2 | HIV infection |
| 125223101 | 12522310 | 3 | HIV infection |
| 125223101 | 12522310 | 4 | HIV infection |
| 125223101 | 12522310 | 5 | HIV infection |
| 125223101 | 12522310 | 6 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125223101 | 12522310 | OT |
| 125223101 | 12522310 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125223101 | 12522310 | Blood bilirubin increased | |
| 125223101 | 12522310 | Blood glucose decreased | |
| 125223101 | 12522310 | Foetal exposure during pregnancy | |
| 125223101 | 12522310 | Hydrocele | |
| 125223101 | 12522310 | Low birth weight baby | |
| 125223101 | 12522310 | Neutrophil count decreased | |
| 125223101 | 12522310 | Polydactyly | |
| 125223101 | 12522310 | Premature baby | |
| 125223101 | 12522310 | Sepsis | |
| 125223101 | 12522310 | Testicular torsion | |
| 125223101 | 12522310 | Vomiting | |
| 125223101 | 12522310 | Vulval disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |