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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127567761 | 12756776 | 1 | I | 20150328 | 20150519 | 20160917 | 20160917 | EXP | JP-AMGEN-JPNCT2015052571 | AMGEN | 66.00 | YR | E | M | Y | 60.60000 | KG | 20160917 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127567761 | 12756776 | 1 | PS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WK | 16.1860466 | MG/KG | Y | U | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 127567761 | 12756776 | 2 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WK | 16.1860466 | MG/KG | Y | U | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 127567761 | 12756776 | 3 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WK | 16.1860466 | MG/KG | Y | U | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 127567761 | 12756776 | 4 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | UNK UNK, Q2WK | 16.1860466 | MG/KG | Y | U | 125147 | SOLUTION FOR INJECTION | QOW | ||||
| 127567761 | 12756776 | 5 | SS | LOXOPROFEN EMEC | LOXOPROFEN | 1 | Oral | 60 MG, BID | 5880 | MG | U | 0 | 60 | MG | BID | ||||
| 127567761 | 12756776 | 6 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, Q2WK | 7553.48828 | MG/M2 | U | 0 | 400 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 7 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | 7553.48828 | MG/M2 | U | 0 | 2400 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 8 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, Q2WEEKS | 7553.48828 | MG/M2 | U | 0 | 400 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 9 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | 7553.48828 | MG/M2 | U | 0 | 2400 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 10 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK UNK, Q2WEEKS | 7553.48828 | MG/M2 | U | 0 | QOW | ||||||
| 127567761 | 12756776 | 11 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG/M2, Q2WEEKS | 229.302322 | MG/M2 | U | 0 | 85 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 12 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG/M2, Q2WEEKS | 229.302322 | MG/M2 | U | 0 | 85 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 13 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 800 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 14 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 800 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 127567761 | 12756776 | 15 | C | OXYCODONE | OXYCODONE | 1 | Oral | 5 MG, BID | 410 | MG | U | 0 | 5 | MG | BID | ||||
| 127567761 | 12756776 | 16 | C | OXYCODONE | OXYCODONE | 1 | Oral | 5 MG, BID | 410 | MG | U | 0 | 5 | MG | BID | ||||
| 127567761 | 12756776 | 17 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | BID | ||||||
| 127567761 | 12756776 | 18 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | BID | ||||||
| 127567761 | 12756776 | 19 | C | MINOCYCLINE HYDROCHLORIDE. | MINOCYCLINE HYDROCHLORIDE | 1 | Oral | 100 MG, BID | 11000 | MG | U | 0 | 100 | MG | BID | ||||
| 127567761 | 12756776 | 20 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | Oral | 2 MG, UNK | U | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127567761 | 12756776 | 1 | Rectal cancer |
| 127567761 | 12756776 | 5 | Cancer pain |
| 127567761 | 12756776 | 6 | Rectal cancer |
| 127567761 | 12756776 | 11 | Rectal cancer |
| 127567761 | 12756776 | 13 | Rectal cancer |
| 127567761 | 12756776 | 15 | Cancer pain |
| 127567761 | 12756776 | 17 | Prophylaxis against gastrointestinal ulcer |
| 127567761 | 12756776 | 19 | Dermatitis acneiform |
| 127567761 | 12756776 | 20 | Nausea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127567761 | 12756776 | HO |
| 127567761 | 12756776 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127567761 | 12756776 | Alanine aminotransferase increased | |
| 127567761 | 12756776 | Amylase increased | |
| 127567761 | 12756776 | Anaemia | |
| 127567761 | 12756776 | Anal haemorrhage | |
| 127567761 | 12756776 | Aspartate aminotransferase increased | |
| 127567761 | 12756776 | Blood alkaline phosphatase increased | |
| 127567761 | 12756776 | Decreased appetite | |
| 127567761 | 12756776 | Dermatitis acneiform | |
| 127567761 | 12756776 | Dry skin | |
| 127567761 | 12756776 | Fatigue | |
| 127567761 | 12756776 | Gamma-glutamyltransferase increased | |
| 127567761 | 12756776 | Gastric ulcer haemorrhage | |
| 127567761 | 12756776 | Gastrointestinal stoma complication | |
| 127567761 | 12756776 | Hypoalbuminaemia | |
| 127567761 | 12756776 | Hypocalcaemia | |
| 127567761 | 12756776 | Hypomagnesaemia | |
| 127567761 | 12756776 | Nausea | |
| 127567761 | 12756776 | Palmar-plantar erythrodysaesthesia syndrome | |
| 127567761 | 12756776 | Paronychia | |
| 127567761 | 12756776 | Peripheral sensory neuropathy | |
| 127567761 | 12756776 | Seborrhoeic dermatitis | |
| 127567761 | 12756776 | Skin hyperpigmentation | |
| 127567761 | 12756776 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 127567761 | 12756776 | 1 | 20150326 | 20150507 | 0 | |
| 127567761 | 12756776 | 2 | 20150611 | 20160510 | 0 | |
| 127567761 | 12756776 | 3 | 20160609 | 20160609 | 0 | |
| 127567761 | 12756776 | 4 | 20160707 | 0 | ||
| 127567761 | 12756776 | 5 | 20150306 | 20150519 | 0 | |
| 127567761 | 12756776 | 6 | 20150326 | 20150507 | 0 | |
| 127567761 | 12756776 | 7 | 20150326 | 20150507 | 0 | |
| 127567761 | 12756776 | 8 | 20150611 | 20160609 | 0 | |
| 127567761 | 12756776 | 9 | 20150611 | 20160609 | 0 | |
| 127567761 | 12756776 | 10 | 20160707 | 0 | ||
| 127567761 | 12756776 | 11 | 20150326 | 20150507 | 0 | |
| 127567761 | 12756776 | 12 | 20150611 | 20150625 | 0 | |
| 127567761 | 12756776 | 13 | 20150326 | 20150507 | 0 | |
| 127567761 | 12756776 | 14 | 20150611 | 20160609 | 0 | |
| 127567761 | 12756776 | 15 | 20150409 | 20150519 | 0 | |
| 127567761 | 12756776 | 16 | 20150526 | 0 | ||
| 127567761 | 12756776 | 17 | 20150519 | 0 | ||
| 127567761 | 12756776 | 18 | 20150527 | 0 | ||
| 127567761 | 12756776 | 19 | 20150326 | 20150519 | 0 | |
| 127567761 | 12756776 | 20 | 20150507 | 20150519 | 0 |