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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111300635 | 11130063 | 5 | F | 20150410 | 20160708 | 20150521 | 20160719 | EXP | PHHO2015FR008901 | NOVARTIS | 82.06 | YR | M | Y | 62.50000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111300635 | 11130063 | 1 | PS | EVEROLIMUS | EVEROLIMUS | 1 | Oral | 2 MG, BID | Y | 21560 | 2 | MG | TABLET | BID | |||||
| 111300635 | 11130063 | 2 | SS | EVEROLIMUS | EVEROLIMUS | 1 | Oral | 0.75 MG, BID | Y | 21560 | .75 | MG | TABLET | BID | |||||
| 111300635 | 11130063 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5 MG, BID | Y | 0 | 5 | MG | BID | ||||||
| 111300635 | 11130063 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | UNK | Y | 0 | |||||||||
| 111300635 | 11130063 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 1 MG, BID | Y | 0 | 1 | MG | BID | ||||||
| 111300635 | 11130063 | 6 | C | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, TWICE (D0 AND D4) | 0 | 20 | MG | ||||||||
| 111300635 | 11130063 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 10 MG, QD | Y | 0 | 10 | MG | QD | ||||||
| 111300635 | 11130063 | 8 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, UNK | Y | 0 | 5 | MG | |||||||
| 111300635 | 11130063 | 9 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 111300635 | 11130063 | 10 | C | EUPANTOL | PANTOPRAZOLE SODIUM | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 111300635 | 11130063 | 11 | C | ARANESP | DARBEPOETIN ALFA | 1 | Subcutaneous | 60 UG, QW | Y | 0 | 60 | UG | /wk | ||||||
| 111300635 | 11130063 | 12 | C | ARANESP | DARBEPOETIN ALFA | 1 | Subcutaneous | UNK | Y | 0 | |||||||||
| 111300635 | 11130063 | 13 | C | NOVONORM | REPAGLINIDE | 1 | Oral | 1 MG, BID | 0 | 1 | MG | BID | |||||||
| 111300635 | 11130063 | 14 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 1 DF, UNK (1 SACHET/DAY IF CONSTIPATION) | U | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111300635 | 11130063 | 1 | Renal transplant |
| 111300635 | 11130063 | 3 | Renal transplant |
| 111300635 | 11130063 | 6 | Renal transplant |
| 111300635 | 11130063 | 7 | Renal transplant |
| 111300635 | 11130063 | 9 | Hypertension |
| 111300635 | 11130063 | 10 | Gastrooesophageal reflux prophylaxis |
| 111300635 | 11130063 | 11 | Anaemia |
| 111300635 | 11130063 | 13 | Diabetes mellitus |
| 111300635 | 11130063 | 14 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111300635 | 11130063 | OT |
| 111300635 | 11130063 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111300635 | 11130063 | Complications of transplanted kidney | |
| 111300635 | 11130063 | Diabetes mellitus | |
| 111300635 | 11130063 | General physical health deterioration | |
| 111300635 | 11130063 | Hypochromic anaemia |
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 |
|---|---|---|---|---|---|---|
| 111300635 | 11130063 | 1 | 20150303 | 0 | ||
| 111300635 | 11130063 | 2 | 20150608 | 0 | ||
| 111300635 | 11130063 | 3 | 20150303 | 0 | ||
| 111300635 | 11130063 | 4 | 20150511 | 0 | ||
| 111300635 | 11130063 | 5 | 20150605 | 0 | ||
| 111300635 | 11130063 | 6 | 20150303 | 20150307 | 0 | |
| 111300635 | 11130063 | 7 | 20150303 | 0 | ||
| 111300635 | 11130063 | 8 | 20150606 | 0 | ||
| 111300635 | 11130063 | 9 | 20150310 | 0 | ||
| 111300635 | 11130063 | 10 | 20150305 | 0 | ||
| 111300635 | 11130063 | 11 | 20150421 | 0 | ||
| 111300635 | 11130063 | 12 | 20150608 | 0 | ||
| 111300635 | 11130063 | 13 | 20150506 | 0 | ||
| 111300635 | 11130063 | 14 | 20150515 | 0 |