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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127127521 | 12712752 | 1 | I | 201604 | 20160830 | 20160902 | 20160902 | EXP | FR-PFIZER INC-2016410237 | PFIZER | 63.00 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127127521 | 12712752 | 1 | PS | RAPAMUNE | SIROLIMUS | 1 | Oral | 2 MG, 1X/DAY | 21110 | 2 | MG | TABLET | QD | ||||||
| 127127521 | 12712752 | 2 | SS | CORTANCYL | PREDNISONE | 1 | Oral | 10 MG, 1X/DAY | 0 | 10 | MG | TABLET | QD | ||||||
| 127127521 | 12712752 | 3 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 75 MG, DAILY | 0 | 75 | MG | |||||||||
| 127127521 | 12712752 | 4 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 127127521 | 12712752 | 5 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 127127521 | 12712752 | 6 | C | KEPPRA | LEVETIRACETAM | 1 | UNK | 0 | |||||||||||
| 127127521 | 12712752 | 7 | C | XANAX | ALPRAZOLAM | 1 | UNK | 0 | |||||||||||
| 127127521 | 12712752 | 8 | C | TEMODAL | TEMOZOLOMIDE | 1 | 300 MG, DAILY (5 DAYS IN 1 MONTH) | 0 | 300 | MG | |||||||||
| 127127521 | 12712752 | 9 | C | TEMODAL | TEMOZOLOMIDE | 1 | 400 MG, DAILY (5 DAYS IN 1 MONTH) | 0 | 400 | MG | |||||||||
| 127127521 | 12712752 | 10 | C | TEMODAL | TEMOZOLOMIDE | 1 | UNK | 0 | |||||||||||
| 127127521 | 12712752 | 11 | C | TEMODAL | TEMOZOLOMIDE | 1 | UNK | 0 | |||||||||||
| 127127521 | 12712752 | 12 | C | ZOPHREN /00955301/ | ONDANSETRON | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127127521 | 12712752 | 1 | Prophylaxis against transplant rejection |
| 127127521 | 12712752 | 2 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127127521 | 12712752 | HO |
| 127127521 | 12712752 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127127521 | 12712752 | Abdominal hernia | |
| 127127521 | 12712752 | Abdominal pain | |
| 127127521 | 12712752 | Dehydration | |
| 127127521 | 12712752 | Diarrhoea | |
| 127127521 | 12712752 | Faecal vomiting | |
| 127127521 | 12712752 | Nausea | |
| 127127521 | 12712752 | Pyrexia | |
| 127127521 | 12712752 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 127127521 | 12712752 | 1 | 201602 | 0 | ||
| 127127521 | 12712752 | 2 | 201602 | 0 | ||
| 127127521 | 12712752 | 6 | 201509 | 0 | ||
| 127127521 | 12712752 | 7 | 201511 | 0 | ||
| 127127521 | 12712752 | 8 | 20160219 | 0 | ||
| 127127521 | 12712752 | 9 | 20160318 | 0 | ||
| 127127521 | 12712752 | 10 | 20160418 | 0 | ||
| 127127521 | 12712752 | 11 | 20160613 | 0 | ||
| 127127521 | 12712752 | 12 | 20160219 | 0 |