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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73095594 | 7309559 | 4 | F | 20091205 | 20121220 | 20100309 | 20121231 | EXP | JP-BRISTOL-MYERS SQUIBB COMPANY-14931786 | BRISTOL MYERS SQUIBB | 66.00 | YR | M | Y | 70.00000 | KG | 20121231 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73095594 | 7309559 | 1 | PS | ERBITUX SOLN FOR INF 5MG/ML | 1 | INTRAVENOUS DRIP | 693 MG ON 02DEC09 445 MG FROM 09DEC09 16DEC09:3INF RECENT 400MG/M2:1/WK:IV.REDUCED 250MG/M2 | N | 125084 | 445 | MG | Solution for injection | /wk | ||||||
| 73095594 | 7309559 | 2 | SS | IRINOTECAN HCL | 1 | INTRAVENOUS DRIP | 100MG/M2.IV:1 PER 2 WEEKS | N | 0 | 173 | MG/M**2 | /month | |||||||
| 73095594 | 7309559 | 3 | SS | TEGAFUR + GIMERACIL + OTERACIL POTASSIUM | 1 | ORAL | FORM = CAPSULES.ALSO 40MG/M2:2PER1DAY | U | 0 | 120 | MG | QD | |||||||
| 73095594 | 7309559 | 4 | C | POLARAMINE | 1 | INTRAVENOUS | D | 0 | 5 | MG | /wk | ||||||||
| 73095594 | 7309559 | 5 | C | DECADRON | 1 | INTRAVENOUS | D | 0 | 8 | MG | /wk | ||||||||
| 73095594 | 7309559 | 6 | C | PRIMPERAN | 1 | INTRAVENOUS | D | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 73095594 | 7309559 | 1 | Rectal cancer |
| 73095594 | 7309559 | 2 | Rectal cancer |
| 73095594 | 7309559 | 3 | Rectal cancer |
| 73095594 | 7309559 | 4 | Premedication |
| 73095594 | 7309559 | 5 | Premedication |
| 73095594 | 7309559 | 6 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 73095594 | 7309559 | OT |
| 73095594 | 7309559 | HO |
| 73095594 | 7309559 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 73095594 | 7309559 | Acne | |
| 73095594 | 7309559 | Anaemia | |
| 73095594 | 7309559 | Decreased appetite | |
| 73095594 | 7309559 | Fatigue | |
| 73095594 | 7309559 | Gastric ulcer | |
| 73095594 | 7309559 | Gastrointestinal haemorrhage | |
| 73095594 | 7309559 | Hypotension |
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 |
|---|---|---|---|---|---|---|
| 73095594 | 7309559 | 1 | 20091202 | 0 | ||
| 73095594 | 7309559 | 2 | 20091202 | 0 | ||
| 73095594 | 7309559 | 3 | 20091202 | 20091209 | 0 | |
| 73095594 | 7309559 | 6 | 20091207 | 20091216 | 0 |