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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125395911 | 12539591 | 1 | I | 20160701 | 20160708 | 20160708 | EXP | DE-STRIDES ARCOLAB LIMITED-2016SP009283 | STRIDES | PADBERG S, WACKER E, MEISTER R, PANSE M, WEBER-SCHOENDORFER C, OPPERMANN M, SCHAEFER C. OBSERVATIONAL COHORT STUDY OF PREGNANCY OUTCOME AFTER FIRSTTRIMESTER EXPOSURE TO FLUOROQUINOLONES. ANTIMICROBIAL AGENTS CHEMOTHERAPY. 2014;58(8):4392-4398 | 0.00 | Y | 0.00000 | 20160708 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125395911 | 12539591 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | UNK | U | U | 0 | ||||||||
| 125395911 | 12539591 | 2 | SS | IBUPROFEN. | IBUPROFEN | 1 | Transplacental | UNK | U | U | 0 | ||||||||
| 125395911 | 12539591 | 3 | SS | OFLOXACIN. | OFLOXACIN | 1 | Transplacental | UNK | 0 | ||||||||||
| 125395911 | 12539591 | 4 | SS | ARBUTIN | ARBUTIN | 1 | Transplacental | UNK | 0 | ||||||||||
| 125395911 | 12539591 | 5 | SS | AMOXICILLIN. | AMOXICILLIN | 1 | Transplacental | UNK | 0 | ||||||||||
| 125395911 | 12539591 | 6 | SS | ACYCLOVIR. | ACYCLOVIR | 1 | Transplacental | UNK | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125395911 | 12539591 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125395911 | 12539591 | Atrial septal defect | |
| 125395911 | 12539591 | Coarctation of the aorta | |
| 125395911 | 12539591 | Foetal exposure during pregnancy | |
| 125395911 | 12539591 | Patent ductus arteriosus | |
| 125395911 | 12539591 | Persistent left superior vena cava |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |