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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1164797311 | 11647973 | 11 | F | 20141016 | 20160713 | 20151021 | 20160718 | EXP | PHJP2015JP018002 | NOVARTIS | 77.03 | YR | F | Y | 47.00000 | KG | 20160718 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1164797311 | 11647973 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 50 MG, QID | 100200 | MG | Y | 50715 | 50 | MG | CAPSULE | QID | |||
| 1164797311 | 11647973 | 2 | SS | PREDNISOLON | PREDNISOLONE | 1 | Oral | 7.5 MG, UNK | Y | 0 | 7.5 | MG | TABLET | ||||||
| 1164797311 | 11647973 | 3 | SS | PREDNISOLON | PREDNISOLONE | 1 | Oral | 2.5 MG, QD | Y | 0 | 2.5 | MG | TABLET | QD | |||||
| 1164797311 | 11647973 | 4 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 1164797311 | 11647973 | 5 | C | TRAMCET | ACETAMINOPHENTRAMADOL | 1 | Oral | 1 DF, TID | 0 | 1 | DF | TABLET | TID | ||||||
| 1164797311 | 11647973 | 6 | C | DOMPERIDONE | DOMPERIDONE | 1 | Oral | 10 MG, TID | 0 | 10 | MG | TABLET | TID | ||||||
| 1164797311 | 11647973 | 7 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | 0 | 15 | MG | TABLET | QD | ||||||
| 1164797311 | 11647973 | 8 | C | MICAMLO | AMLODIPINE BESYLATETELMISARTAN | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1164797311 | 11647973 | 9 | C | EDIROL | ELDECALCITOL | 1 | Oral | 0.75 UG, QD | 0 | .75 | UG | CAPSULE | QD | ||||||
| 1164797311 | 11647973 | 10 | C | NOVORAPID | INSULIN ASPART | 1 | Subcutaneous | 29 IU, UNK | 0 | 29 | IU | INJECTION | |||||||
| 1164797311 | 11647973 | 11 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 10 IU, UNK | 0 | 10 | IU | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1164797311 | 11647973 | 1 | Aplasia pure red cell |
| 1164797311 | 11647973 | 2 | Aplasia pure red cell |
| 1164797311 | 11647973 | 3 | Rheumatoid arthritis |
| 1164797311 | 11647973 | 4 | Rheumatoid arthritis |
| 1164797311 | 11647973 | 5 | Rheumatoid arthritis |
| 1164797311 | 11647973 | 6 | Gastrooesophageal reflux disease |
| 1164797311 | 11647973 | 7 | Gastrooesophageal reflux disease |
| 1164797311 | 11647973 | 8 | Hypertension |
| 1164797311 | 11647973 | 9 | Osteoporosis |
| 1164797311 | 11647973 | 10 | Diabetes mellitus |
| 1164797311 | 11647973 | 11 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1164797311 | 11647973 | HO |
| 1164797311 | 11647973 | LT |
| 1164797311 | 11647973 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1164797311 | 11647973 | Abscess | |
| 1164797311 | 11647973 | Breath sounds abnormal | |
| 1164797311 | 11647973 | Dyspnoea | |
| 1164797311 | 11647973 | Dysstasia | |
| 1164797311 | 11647973 | Hypoalbuminaemia | |
| 1164797311 | 11647973 | Infectious pleural effusion | |
| 1164797311 | 11647973 | Inflammation | |
| 1164797311 | 11647973 | Malaise | |
| 1164797311 | 11647973 | Mass | |
| 1164797311 | 11647973 | Nocardiosis | |
| 1164797311 | 11647973 | Oesophageal candidiasis | |
| 1164797311 | 11647973 | Pneumonia | |
| 1164797311 | 11647973 | Product use issue | |
| 1164797311 | 11647973 | Pyrexia | |
| 1164797311 | 11647973 | Renal impairment | |
| 1164797311 | 11647973 | Respiratory failure | |
| 1164797311 | 11647973 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 1164797311 | 11647973 | 1 | 20130603 | 20141020 | 0 | |
| 1164797311 | 11647973 | 3 | 20141020 | 0 |