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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421311 | 12542131 | 1 | I | 20160704 | 20160708 | 20160708 | EXP | ZA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43762BI | BOEHRINGER INGELHEIM | KAKANDE B,ISAACS T,MULOIWA R,DLAMINI S,LEHLOENYA R. CASE REPORT: STEVENS - JOHNSON SYNDROME FOLLOWING A SINGLE DOUBLE DOSING OF NEVIRAPINE-CONTAINING REGIMEN ONCE ON AN HIV-INFECTED WOMEN ON LONG-TERM ANTIRETROVIRAL THERAPY.[VERSION1;REFEREES: 1 APPROVED, 2 APPROVED WITH RESERVATIONS]. F1000 RESEARCH 2015;4:175. | 31.00 | YR | F | Y | 0.00000 | 20160708 | OT | COUNTRY NOT SPECIFIED | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421311 | 12542131 | 1 | PS | VIRAMUNE | NEVIRAPINE | 1 | Unknown | 400 MG | N | 20933 | 400 | MG | QD | ||||||
| 125421311 | 12542131 | 2 | SS | VIRAMUNE | NEVIRAPINE | 1 | Unknown | 800 MG | N | 20933 | 400 | MG | BID | ||||||
| 125421311 | 12542131 | 3 | SS | TENOFOVIR | TENOFOVIR | 1 | Unknown | 300 MG | N | 0 | 300 | MG | QD | ||||||
| 125421311 | 12542131 | 4 | SS | TENOFOVIR | TENOFOVIR | 1 | Unknown | 600 MG | N | 0 | 300 | MG | BID | ||||||
| 125421311 | 12542131 | 5 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | 300 MG | N | 0 | 300 | MG | QD | ||||||
| 125421311 | 12542131 | 6 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | 600 MG | N | 0 | 300 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125421311 | 12542131 | 1 | HIV infection |
| 125421311 | 12542131 | 3 | HIV infection |
| 125421311 | 12542131 | 5 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125421311 | 12542131 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125421311 | 12542131 | Drug dose omission | |
| 125421311 | 12542131 | Overdose | |
| 125421311 | 12542131 | Stevens-Johnson syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |