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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113363754 | 11336375 | 4 | F | 20150612 | 20160701 | 20150804 | 20160707 | EXP | US-GILEAD-2015-0165252 | GILEAD | 0.00 | DY | F | Y | 2.29000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113363754 | 11336375 | 1 | PS | EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINETENOFOVIR DISOPROXIL | 1 | Transplacental | 1 DF, QD | 156 | DF | 21752 | 1 | DF | TABLET | QD | ||||
| 113363754 | 11336375 | 2 | SS | DARUNAVIR | DARUNAVIR | 1 | Transplacental | 1200 MG, QD | 187200 | MG | 0 | 1200 | MG | QD | |||||
| 113363754 | 11336375 | 3 | SS | DOLUTEGRAVIR | DOLUTEGRAVIR | 1 | Transplacental | 50 MG, QD | 7800 | MG | 0 | 50 | MG | QD | |||||
| 113363754 | 11336375 | 4 | SS | RITONAVIR. | RITONAVIR | 1 | Transplacental | 200 MG, QD | 31200 | MG | 0 | 200 | MG | QD | |||||
| 113363754 | 11336375 | 5 | C | DAPSONE. | DAPSONE | 1 | Transplacental | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 113363754 | 11336375 | 6 | C | CEPHALEXIN /00145501/ | CEPHALEXIN | 1 | Transplacental | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 113363754 | 11336375 | 7 | C | DIFLUCAN | FLUCONAZOLE | 1 | Transplacental | 150 MG, ONCE | 0 | 150 | MG | 1X | |||||||
| 113363754 | 11336375 | 8 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Transplacental | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 113363754 | 11336375 | 9 | C | MACROBID | NITROFURANTOINNITROFURANTOIN MONOHYDRATE | 1 | Transplacental | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 113363754 | 11336375 | 10 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Transplacental | 1200 MG, Q1WK | 0 | 1200 | MG | /wk | |||||||
| 113363754 | 11336375 | 11 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113363754 | 11336375 | 1 | HIV infection |
| 113363754 | 11336375 | 2 | HIV infection |
| 113363754 | 11336375 | 3 | HIV infection |
| 113363754 | 11336375 | 4 | HIV infection |
| 113363754 | 11336375 | 5 | Product used for unknown indication |
| 113363754 | 11336375 | 6 | Product used for unknown indication |
| 113363754 | 11336375 | 7 | Product used for unknown indication |
| 113363754 | 11336375 | 8 | Product used for unknown indication |
| 113363754 | 11336375 | 9 | Product used for unknown indication |
| 113363754 | 11336375 | 10 | Product used for unknown indication |
| 113363754 | 11336375 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113363754 | 11336375 | CA |
| 113363754 | 11336375 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113363754 | 11336375 | Cerebral calcification | |
| 113363754 | 11336375 | Foetal exposure during pregnancy | |
| 113363754 | 11336375 | Foetal growth restriction |
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 |
|---|---|---|---|---|---|---|
| 113363754 | 11336375 | 1 | 20150107 | 20150612 | 0 | |
| 113363754 | 11336375 | 2 | 20150107 | 20150612 | 0 | |
| 113363754 | 11336375 | 3 | 20150107 | 20150612 | 0 | |
| 113363754 | 11336375 | 4 | 20150107 | 20150612 | 0 |