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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115060002 | 11506000 | 2 | F | 20150116 | 20160726 | 20150915 | 20160729 | EXP | FR-009507513-1509FRA005485 | MERCK | 1.80 | MON | M | Y | 0.00000 | 20160729 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115060002 | 11506000 | 1 | PS | CELESTENE | BETAMETHASONE | 1 | Intravenous (not otherwise specified) | 0.25 MG/KG/DAY | .563 | MG/KG | U | 14215 | .25 | MG/KG | ORAL SOLUTION | QD | |||
| 115060002 | 11506000 | 2 | SS | CELESTENE | BETAMETHASONE | 1 | Intravenous (not otherwise specified) | 0.063 MG/KG/DAY | .563 | MG/KG | U | 14215 | ORAL SOLUTION | QD | |||||
| 115060002 | 11506000 | 3 | SS | RIFAMYCINE CHIBRET | RIFAMYCIN | 1 | Intraocular | UNK | U | 0 | |||||||||
| 115060002 | 11506000 | 4 | SS | caffeine cooper | CAFFEINE | 1 | Unknown | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 5 | SS | PULMICORT TURBUHALER | BUDESONIDE | 1 | 0.25 MG, Q12H | 3 | MG | U | 0 | .25 | MG | Q12H | |||||
| 115060002 | 11506000 | 6 | SS | ALDACTONE | SPIRONOLACTONE | 1 | Unknown | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 7 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 10 MG/KG, UNK | U | 0 | 10 | MG/KG | |||||||
| 115060002 | 11506000 | 8 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 5 MG/KG FROM DAY 2 TO DAY 6 | U | 0 | 5 | MG/KG | |||||||
| 115060002 | 11506000 | 9 | SS | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Intravenous (not otherwise specified) | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 10 | SS | INEXIUM (esomeprazole sodium) | ESOMEPRAZOLE SODIUM | 1 | Oral | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 11 | SS | NEO-SYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Intraocular | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 12 | SS | NEO-SYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Intraocular | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 13 | SS | MYDRIATICUM | TROPICAMIDE | 1 | Intraocular | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 14 | SS | MYDRIATICUM | TROPICAMIDE | 1 | Intraocular | UNSPECIFIED | U | 0 | |||||||||
| 115060002 | 11506000 | 15 | SS | FERROSTRANE | SODIUM FEREDETATE | 1 | Oral | 2 MG/KG, QD | 16 | MG/KG | U | 0 | 2 | MG/KG | QD | ||||
| 115060002 | 11506000 | 16 | SS | FERROSTRANE | SODIUM FEREDETATE | 1 | Oral | 3 MG/KG, QD | 16 | MG/KG | U | 0 | 3 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115060002 | 11506000 | 1 | Bronchopulmonary dysplasia |
| 115060002 | 11506000 | 3 | Infection prophylaxis |
| 115060002 | 11506000 | 4 | Infantile apnoea |
| 115060002 | 11506000 | 5 | Bronchopulmonary dysplasia |
| 115060002 | 11506000 | 6 | Bronchopulmonary dysplasia |
| 115060002 | 11506000 | 7 | Patent ductus arteriosus |
| 115060002 | 11506000 | 9 | Product used for unknown indication |
| 115060002 | 11506000 | 10 | Product used for unknown indication |
| 115060002 | 11506000 | 11 | Diagnostic procedure |
| 115060002 | 11506000 | 13 | Diagnostic procedure |
| 115060002 | 11506000 | 15 | Anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115060002 | 11506000 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115060002 | 11506000 | Apnoea | |
| 115060002 | 11506000 | Atelectasis | |
| 115060002 | 11506000 | Enterococcal bacteraemia | |
| 115060002 | 11506000 | Haemoglobin decreased | |
| 115060002 | 11506000 | Hypotonia | |
| 115060002 | 11506000 | Mydriasis | |
| 115060002 | 11506000 | Necrotising enterocolitis neonatal | |
| 115060002 | 11506000 | Platelet count decreased | |
| 115060002 | 11506000 | Staphylococcus test positive |
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 |
|---|---|---|---|---|---|---|
| 115060002 | 11506000 | 1 | 20141221 | 20141222 | 0 | |
| 115060002 | 11506000 | 2 | 20141223 | 20141223 | 0 | |
| 115060002 | 11506000 | 3 | 20141123 | 0 | ||
| 115060002 | 11506000 | 4 | 20141123 | 20150124 | 0 | |
| 115060002 | 11506000 | 5 | 20141217 | 20141222 | 0 | |
| 115060002 | 11506000 | 6 | 20141217 | 20150116 | 0 | |
| 115060002 | 11506000 | 7 | 20141124 | 20141124 | 0 | |
| 115060002 | 11506000 | 8 | 20141125 | 20141129 | 0 | |
| 115060002 | 11506000 | 9 | 20141229 | 20150106 | 0 | |
| 115060002 | 11506000 | 10 | 20150106 | 20150117 | 0 | |
| 115060002 | 11506000 | 11 | 20150106 | 0 | ||
| 115060002 | 11506000 | 12 | 20150120 | 0 | ||
| 115060002 | 11506000 | 13 | 20150106 | 0 | ||
| 115060002 | 11506000 | 14 | 20150120 | 0 | ||
| 115060002 | 11506000 | 15 | 20150110 | 20150114 | 0 | |
| 115060002 | 11506000 | 16 | 20150115 | 20150116 | 0 |