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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127975311 | 12797531 | 1 | I | 20160824 | 20160920 | 20160930 | 20160930 | EXP | FR-BAXTER-2016BAX048680 | BAXTER | 38.65 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127975311 | 12797531 | 1 | PS | HOLOXAN 2000 MG, POUDRE POUR USAGE PARENT?RAL | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 2400 MG/M? | D | 0 | 4120 | MG | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||
| 127975311 | 12797531 | 2 | SS | HOLOXAN 2000 MG, POUDRE POUR USAGE PARENT?RAL | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 2400 MG/M? | D | 0 | 4120 | MG | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||
| 127975311 | 12797531 | 3 | SS | Carboplatin Hospira | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | DOSE: 200 MG/M2 | D | 0 | 340 | MG | /cycle | ||||||
| 127975311 | 12797531 | 4 | SS | Carboplatin Hospira | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | DOSE: 200 MG/M2 | D | 0 | 340 | MG | /cycle | ||||||
| 127975311 | 12797531 | 5 | SS | Etoposide Mylan | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | DOSE: 150 MG/M2 | D | 0 | 260 | MG | /cycle | ||||||
| 127975311 | 12797531 | 6 | SS | Mesna EG | MESNA | 1 | Intravenous (not otherwise specified) | DOSE: 2880 MG/M2 | D | 0 | 5000 | MG | /cycle | ||||||
| 127975311 | 12797531 | 7 | SS | Solupred | PREDNISOLONE | 1 | Oral | D | 0 | 60 | MG | /cycle | |||||||
| 127975311 | 12797531 | 8 | SS | EMEND | APREPITANT | 1 | Oral | D | 0 | 80 | MG | CAPSULE | /cycle | ||||||
| 127975311 | 12797531 | 9 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | D | 0 | 260 | UG | SOLUTION FOR INJECTION | /cycle | ||||||
| 127975311 | 12797531 | 10 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | D | 0 | 260 | UG | SOLUTION FOR INJECTION | /cycle | ||||||
| 127975311 | 12797531 | 11 | SS | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | DOSAGE FORM: SCORED TABLETS | D | 0 | 10 | MG | TABLET | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127975311 | 12797531 | 1 | Testis cancer |
| 127975311 | 12797531 | 3 | Testis cancer |
| 127975311 | 12797531 | 5 | Testis cancer |
| 127975311 | 12797531 | 6 | Prophylaxis |
| 127975311 | 12797531 | 7 | Prophylaxis |
| 127975311 | 12797531 | 8 | Prophylaxis of nausea and vomiting |
| 127975311 | 12797531 | 9 | Prophylaxis of nausea and vomiting |
| 127975311 | 12797531 | 11 | Prophylaxis of nausea and vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127975311 | 12797531 | DE |
| 127975311 | 12797531 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127975311 | 12797531 | Acute kidney injury | |
| 127975311 | 12797531 | Blood pressure decreased | |
| 127975311 | 12797531 | Bone marrow failure | |
| 127975311 | 12797531 | Cardio-respiratory arrest | |
| 127975311 | 12797531 | Dehydration | |
| 127975311 | 12797531 | Diarrhoea | |
| 127975311 | 12797531 | General physical health deterioration | |
| 127975311 | 12797531 | Hypovolaemia | |
| 127975311 | 12797531 | Lung infection | |
| 127975311 | 12797531 | Oxygen saturation decreased | |
| 127975311 | 12797531 | Polyuria | |
| 127975311 | 12797531 | Pyrexia | |
| 127975311 | 12797531 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127975311 | 12797531 | 1 | 20160822 | 20160822 | 0 | |
| 127975311 | 12797531 | 2 | 20160824 | 20160826 | 0 | |
| 127975311 | 12797531 | 3 | 20160823 | 20160824 | 0 | |
| 127975311 | 12797531 | 4 | 20160826 | 20160826 | 0 | |
| 127975311 | 12797531 | 5 | 20160823 | 20160826 | 0 | |
| 127975311 | 12797531 | 6 | 20160823 | 20160826 | 0 | |
| 127975311 | 12797531 | 7 | 20160822 | 20160826 | 0 | |
| 127975311 | 12797531 | 8 | 20160822 | 20160826 | 0 | |
| 127975311 | 12797531 | 9 | 20160822 | 20160822 | 0 | |
| 127975311 | 12797531 | 10 | 20160824 | 20160824 | 0 | |
| 127975311 | 12797531 | 11 | 20160822 | 20160826 | 0 |