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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126869411 | 12686941 | 1 | I | 20160719 | 20160816 | 20160826 | 20160826 | EXP | FR-BAXTER-2016BAX043193 | BAXTER | 81.92 | YR | M | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126869411 | 12686941 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Unknown | Y | 12142 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 126869411 | 12686941 | 2 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | FIRST COURSE | Y | 12142 | 1 | G | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 126869411 | 12686941 | 3 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | SECOND COURSE | Y | 12142 | 1 | G | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 126869411 | 12686941 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 126869411 | 12686941 | 5 | SS | tocilizumab | TOCILIZUMAB | 1 | Unknown | 0 | |||||||||||
| 126869411 | 12686941 | 6 | SS | KINERET | ANAKINRA | 1 | Unknown | 0 | |||||||||||
| 126869411 | 12686941 | 7 | C | Cortancyl | PREDNISONE | 1 | Unknown | 0 | 7 | MG | QD | ||||||||
| 126869411 | 12686941 | 8 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 1 TABLET ACCORDING TO HAEMATOLOGICAL TOLERANCE | 0 | TABLET | TIW | ||||||||
| 126869411 | 12686941 | 9 | C | valaciclovir | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 2 TABLETS | 0 | TABLET | QD | ||||||||
| 126869411 | 12686941 | 10 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 2 PUFFS, ONCE IN THE MORNING | 0 | ||||||||||
| 126869411 | 12686941 | 11 | C | Bisoce | BISOPROLOL | 1 | Unknown | 1 TABLET | 0 | TABLET | QD | ||||||||
| 126869411 | 12686941 | 12 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 1 TABLET | 0 | TABLET | QD | ||||||||
| 126869411 | 12686941 | 13 | C | Diffu K | POTASSIUM CHLORIDE | 1 | Unknown | 2 TABLETS | 0 | TABLET | QD | ||||||||
| 126869411 | 12686941 | 14 | C | alfuzosine | ALFUZOSIN HYDROCHLORIDE | 1 | Unknown | 1 TABLET | 0 | TABLET | QD | ||||||||
| 126869411 | 12686941 | 15 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | IF INSOMNIA AT BEDTIME | 0 | ||||||||||
| 126869411 | 12686941 | 16 | C | XARELTO | RIVAROXABAN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126869411 | 12686941 | 1 | Polychondritis |
| 126869411 | 12686941 | 4 | Polychondritis |
| 126869411 | 12686941 | 5 | Polychondritis |
| 126869411 | 12686941 | 6 | Polychondritis |
| 126869411 | 12686941 | 7 | Product used for unknown indication |
| 126869411 | 12686941 | 8 | Product used for unknown indication |
| 126869411 | 12686941 | 9 | Product used for unknown indication |
| 126869411 | 12686941 | 10 | Product used for unknown indication |
| 126869411 | 12686941 | 11 | Product used for unknown indication |
| 126869411 | 12686941 | 12 | Product used for unknown indication |
| 126869411 | 12686941 | 13 | Product used for unknown indication |
| 126869411 | 12686941 | 14 | Product used for unknown indication |
| 126869411 | 12686941 | 15 | Insomnia |
| 126869411 | 12686941 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126869411 | 12686941 | OT |
| 126869411 | 12686941 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126869411 | 12686941 | Abdominal pain | |
| 126869411 | 12686941 | Acute kidney injury | |
| 126869411 | 12686941 | Adenocarcinoma of colon | |
| 126869411 | 12686941 | Dehydration | |
| 126869411 | 12686941 | Diarrhoea | |
| 126869411 | 12686941 | Pancytopenia | |
| 126869411 | 12686941 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 126869411 | 12686941 | 1 | 201508 | 201602 | 0 | |
| 126869411 | 12686941 | 2 | 20160624 | 0 | ||
| 126869411 | 12686941 | 3 | 20160719 | 20160719 | 0 | |
| 126869411 | 12686941 | 6 | 201402 | 201508 | 0 |