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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833441 | 12783344 | 1 | I | 20160914 | 20160927 | 20160927 | EXP | ES-APOTEX-2016AP011964 | APOTEX | SAFONT A, DONAZAR M, GASTON B, BARRENETXEA J, URTASUN M, GARCIA S, ET AL.. FETAL SUPRAVENTRICULAR TACHYCARDIA IN A TRIPLET PREGNANCY. J-MATERN-FETAL-NEONAT-MED. 2016;29:124-125 | 0.00 | N | M | Y | 0.00000 | 20160927 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833441 | 12783344 | 1 | PS | FLECAINIDA APOTEX COMPRIMIDOS EFG | FLECAINIDE | 1 | Transplacental | UNK | U | U | 79337 | TABLET | |||||||
| 127833441 | 12783344 | 2 | SS | FLECAINIDA APOTEX COMPRIMIDOS EFG | FLECAINIDE | 1 | Transplacental | INCREASED | U | U | 79337 | TABLET | |||||||
| 127833441 | 12783344 | 3 | SS | FLECAINIDA APOTEX COMPRIMIDOS EFG | FLECAINIDE | 1 | Unknown | UNK | U | U | 79337 | TABLET | |||||||
| 127833441 | 12783344 | 4 | SS | DIGOXIN. | DIGOXIN | 1 | Transplacental | UNK | 0 | ||||||||||
| 127833441 | 12783344 | 5 | SS | DIGOXIN. | DIGOXIN | 1 | Transplacental | UNK | 0 | ||||||||||
| 127833441 | 12783344 | 6 | SS | DIGOXIN. | DIGOXIN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127833441 | 12783344 | 1 | Supraventricular tachycardia |
| 127833441 | 12783344 | 2 | Hydrops foetalis |
| 127833441 | 12783344 | 4 | Supraventricular tachycardia |
| 127833441 | 12783344 | 5 | Hydrops foetalis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127833441 | 12783344 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127833441 | 12783344 | Ascites | |
| 127833441 | 12783344 | Caesarean section | |
| 127833441 | 12783344 | Condition aggravated | |
| 127833441 | 12783344 | Electrocardiogram QRS complex prolonged | |
| 127833441 | 12783344 | Foetal exposure during pregnancy | |
| 127833441 | 12783344 | Neonatal tachycardia | |
| 127833441 | 12783344 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |