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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118530234 | 11853023 | 4 | F | 201310 | 20160706 | 20151218 | 20160712 | PER | PHHY2014US084645 | NOVARTIS | 23.10 | YR | F | Y | 102.00000 | KG | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118530234 | 11853023 | 1 | PS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, BID | 200 | MG | 103764 | 20 | MG | BID | |||||
| 118530234 | 11853023 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 2.5 MG, BID | 287 | MG | 0 | 2.5 | MG | CAPSULE | BID | ||||
| 118530234 | 11853023 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6 MG, QD | 287 | MG | 0 | 6 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 4.5 MG, QD | 287 | MG | 0 | 4.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, QD | 287 | MG | 0 | 3 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 8 MG, QD | 287 | MG | 0 | 8 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 10 MG, QD | 287 | MG | 0 | 10 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 9 MG, QD | 287 | MG | 0 | 9 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6 MG, QD | 287 | MG | 0 | 6 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6.5 MG, QD | 287 | MG | 0 | 6.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 11 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 7 MG, QD | 287 | MG | 0 | 7 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 12 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6.5 MG, QD | 287 | MG | 0 | 6.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 13 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6 MG, QD | 287 | MG | 0 | 6 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 14 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 6.5 MG, QD | 287 | MG | 0 | 6.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 15 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5.5 MG, QD | 287 | MG | 0 | 5.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 16 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 4 MG, QD | 287 | MG | 0 | 4 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 17 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, QD | 287 | MG | 0 | 3 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 18 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3.5 MG, QD | 287 | MG | 0 | 3.5 | MG | CAPSULE | QD | ||||
| 118530234 | 11853023 | 19 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, BID | 287 | MG | 0 | 3 | MG | CAPSULE | BID | ||||
| 118530234 | 11853023 | 20 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 500 MG, QID | 10000 | MG | Y | 0 | 500 | MG | QID | ||||
| 118530234 | 11853023 | 21 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 360 MG, QID | 10000 | MG | Y | 0 | 360 | MG | QID | ||||
| 118530234 | 11853023 | 22 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 118530234 | 11853023 | 23 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 118530234 | 11853023 | 24 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 118530234 | 11853023 | 25 | C | MYCELEX | CLOTRIMAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 118530234 | 11853023 | 26 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Unknown | UNK | 0 | ||||||||||
| 118530234 | 11853023 | 27 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118530234 | 11853023 | 1 | Renal transplant |
| 118530234 | 11853023 | 2 | Renal transplant |
| 118530234 | 11853023 | 20 | Renal transplant |
| 118530234 | 11853023 | 22 | Product used for unknown indication |
| 118530234 | 11853023 | 24 | Product used for unknown indication |
| 118530234 | 11853023 | 25 | Product used for unknown indication |
| 118530234 | 11853023 | 26 | Product used for unknown indication |
| 118530234 | 11853023 | 27 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118530234 | 11853023 | OT |
| 118530234 | 11853023 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118530234 | 11853023 | Headache | |
| 118530234 | 11853023 | Kidney transplant rejection | |
| 118530234 | 11853023 | Metabolic acidosis | |
| 118530234 | 11853023 | Polyomavirus-associated nephropathy | |
| 118530234 | 11853023 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 118530234 | 11853023 | 1 | 20130808 | 20130812 | 0 | |
| 118530234 | 11853023 | 2 | 20130809 | 20130809 | 0 | |
| 118530234 | 11853023 | 3 | 20140220 | 20140410 | 0 | |
| 118530234 | 11853023 | 4 | 20140411 | 20140411 | 0 | |
| 118530234 | 11853023 | 5 | 20140412 | 20140415 | 0 | |
| 118530234 | 11853023 | 6 | 20140416 | 20140416 | 0 | |
| 118530234 | 11853023 | 7 | 20140417 | 20140417 | 0 | |
| 118530234 | 11853023 | 8 | 20140418 | 20140418 | 0 | |
| 118530234 | 11853023 | 9 | 20140419 | 20140421 | 0 | |
| 118530234 | 11853023 | 10 | 20140422 | 20140422 | 0 | |
| 118530234 | 11853023 | 11 | 20140423 | 20140506 | 0 | |
| 118530234 | 11853023 | 12 | 20140507 | 20140507 | 0 | |
| 118530234 | 11853023 | 13 | 20140508 | 20140513 | 0 | |
| 118530234 | 11853023 | 14 | 20140514 | 20140514 | 0 | |
| 118530234 | 11853023 | 15 | 20140515 | 20140615 | 0 | |
| 118530234 | 11853023 | 16 | 20140616 | 20140616 | 0 | |
| 118530234 | 11853023 | 17 | 20140617 | 20140910 | 0 | |
| 118530234 | 11853023 | 18 | 20140911 | 0 | ||
| 118530234 | 11853023 | 19 | 20140214 | 0 | ||
| 118530234 | 11853023 | 20 | 20130809 | 20130813 | 0 | |
| 118530234 | 11853023 | 21 | 20140318 | 0 | ||
| 118530234 | 11853023 | 22 | 20130813 | 0 | ||
| 118530234 | 11853023 | 23 | 20141011 | 20150404 | 0 | |
| 118530234 | 11853023 | 24 | 20131022 | 0 | ||
| 118530234 | 11853023 | 25 | 20141008 | 0 | ||
| 118530234 | 11853023 | 26 | 20141019 | 0 | ||
| 118530234 | 11853023 | 27 | 20141114 | 20150406 | 0 |