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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125799561 | 12579956 | 1 | I | 2015 | 20160713 | 20160721 | 20160721 | EXP | US-AMGEN-USASP2016091482 | AMGEN | 79.00 | YR | E | F | Y | 59.42000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125799561 | 12579956 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | 125320 | SOLUTION FOR INJECTION | |||||||||
| 125799561 | 12579956 | 2 | SS | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | Unknown | UNK | 0 | ||||||||||
| 125799561 | 12579956 | 3 | SS | PREVNAR 13 | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE | 1 | 0 | ||||||||||||
| 125799561 | 12579956 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 4 MG, QD | 0 | 4 | MG | QD | |||||||
| 125799561 | 12579956 | 5 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 125799561 | 12579956 | 6 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 125799561 | 12579956 | 7 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125799561 | 12579956 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 0.5 MG AT EVENING, QD | 0 | .5 | MG | QD | |||||||
| 125799561 | 12579956 | 9 | C | MESTINON | PYRIDOSTIGMINE BROMIDE | 1 | ONE HALF 60MG, QID | 0 | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125799561 | 12579956 | 1 | Product used for unknown indication |
| 125799561 | 12579956 | 2 | Prophylaxis |
| 125799561 | 12579956 | 3 | Immune system disorder |
| 125799561 | 12579956 | 4 | Dermatomyositis |
| 125799561 | 12579956 | 5 | Myasthenia gravis |
| 125799561 | 12579956 | 6 | Dermatomyositis |
| 125799561 | 12579956 | 7 | Myasthenia gravis |
| 125799561 | 12579956 | 8 | Sleep disorder |
| 125799561 | 12579956 | 9 | Myasthenia gravis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125799561 | 12579956 | HO |
| 125799561 | 12579956 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125799561 | 12579956 | Bone loss | |
| 125799561 | 12579956 | Fatigue | |
| 125799561 | 12579956 | Hospitalisation | |
| 125799561 | 12579956 | Hypersomnia | |
| 125799561 | 12579956 | Lung infection | |
| 125799561 | 12579956 | Osteonecrosis | |
| 125799561 | 12579956 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125799561 | 12579956 | 1 | 2012 | 0 | ||
| 125799561 | 12579956 | 2 | 20151006 | 0 | ||
| 125799561 | 12579956 | 4 | 2003 | 0 | ||
| 125799561 | 12579956 | 6 | 2006 | 0 | ||
| 125799561 | 12579956 | 8 | 2004 | 0 | ||
| 125799561 | 12579956 | 9 | 2008 | 0 |