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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114187746 | 11418774 | 6 | F | 201410 | 20160801 | 20150826 | 20160809 | EXP | US-AMGEN-USASP2015084587 | AMGEN | 1.02 | YR | F | Y | 2.55000 | KG | 20160809 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114187746 | 11418774 | 1 | PS | ENBREL | ETANERCEPT | 1 | Transplacental | 50 UNK, QWK | U | 103795 | UNKNOWN FORMULATION | /wk | |||||||
| 114187746 | 11418774 | 2 | C | CULTURELLE FOR KIDS | 2 | 1 PKG, QD | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114187746 | 11418774 | 1 | Exposure during pregnancy |
| 114187746 | 11418774 | 2 | Probiotic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114187746 | 11418774 | HO |
| 114187746 | 11418774 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114187746 | 11418774 | Developmental delay | |
| 114187746 | 11418774 | Ear infection | |
| 114187746 | 11418774 | Gastrointestinal tube insertion | |
| 114187746 | 11418774 | Gastrooesophageal reflux disease | |
| 114187746 | 11418774 | Gastrostomy | |
| 114187746 | 11418774 | Hypotonia | |
| 114187746 | 11418774 | Jaw disorder | |
| 114187746 | 11418774 | Jejunostomy | |
| 114187746 | 11418774 | Malaise | |
| 114187746 | 11418774 | Micrognathia | |
| 114187746 | 11418774 | Microstomia | |
| 114187746 | 11418774 | Pneumonia | |
| 114187746 | 11418774 | Premature baby | |
| 114187746 | 11418774 | Surgery | |
| 114187746 | 11418774 | Tracheal mass | |
| 114187746 | 11418774 | Tracheostomy | |
| 114187746 | 11418774 | Upper airway obstruction |
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 |
|---|---|---|---|---|---|---|
| 114187746 | 11418774 | 1 | 200105 | 0 | ||
| 114187746 | 11418774 | 2 | 20160212 | 0 |