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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119761864 | 11976186 | 4 | F | 2015 | 20160622 | 20160129 | 20160707 | EXP | US-APOTEX-2016AP005122 | APOTEX | 0.00 | YR | F | Y | 3.43000 | KG | 20160707 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119761864 | 11976186 | 1 | PS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | UNK | Y | 75356 | TABLET | ||||||||
| 119761864 | 11976186 | 2 | SS | EMTRIVA | EMTRICITABINE | 1 | Transplacental | 200 MG/DAY | 0 | 200 | MG | ||||||||
| 119761864 | 11976186 | 3 | SS | SELZENTRY | MARAVIROC | 1 | Transplacental | 300 MG/DAY | 0 | 300 | MG | ||||||||
| 119761864 | 11976186 | 4 | C | MARIJUANA | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119761864 | 11976186 | 1 | Depression |
| 119761864 | 11976186 | 2 | Prophylaxis against HIV infection |
| 119761864 | 11976186 | 3 | Prophylaxis against HIV infection |
| 119761864 | 11976186 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119761864 | 11976186 | OT |
| 119761864 | 11976186 | HO |
| 119761864 | 11976186 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119761864 | 11976186 | Apert's syndrome | |
| 119761864 | 11976186 | Atrial septal defect | |
| 119761864 | 11976186 | Congenital choroid plexus cyst | |
| 119761864 | 11976186 | Foetal exposure during pregnancy | |
| 119761864 | 11976186 | Neonatal respiratory distress syndrome | |
| 119761864 | 11976186 | Neonatal tachypnoea | |
| 119761864 | 11976186 | Patent ductus arteriosus | |
| 119761864 | 11976186 | Syndactyly |
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 |
|---|---|---|---|---|---|---|
| 119761864 | 11976186 | 2 | 20150216 | 20150319 | 0 | |
| 119761864 | 11976186 | 3 | 20150216 | 20150319 | 0 |