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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112724882 | 11272488 | 2 | F | 20150205 | 20160620 | 20150715 | 20160704 | EXP | IT-ACTAVIS-2015-14513 | ACTAVIS | 72.63 | YR | M | Y | 69.00000 | KG | 20160704 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112724882 | 11272488 | 1 | PS | Irinotecan (Unknown) | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 320 MG, CYCLICAL | UNCONFIRMED | 78589 | 320 | MG | UNK | ||||||
| 112724882 | 11272488 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 530 MG, CYCLICAL | 0 | 530 | MG | ||||||||
| 112724882 | 11272488 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 710 MG, CYCLICAL | 0 | 710 | MG | ||||||||
| 112724882 | 11272488 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 3200 MG, CYCLICAL | 0 | 3200 | MG | ||||||||
| 112724882 | 11272488 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 4290 MG, CYCLICAL | 0 | 4290 | MG | ||||||||
| 112724882 | 11272488 | 6 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 350 MG, CYCLICAL | 0 | 350 | MG | ||||||||
| 112724882 | 11272488 | 7 | C | LEVOFOLINIC ACID | LEVOLEUCOVORIN | 1 | Intravenous (not otherwise specified) | 350 MG, UNKNOWN | U | U | 0 | 350 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112724882 | 11272488 | 1 | Adenocarcinoma of colon |
| 112724882 | 11272488 | 2 | Adenocarcinoma of colon |
| 112724882 | 11272488 | 4 | Adenocarcinoma of colon |
| 112724882 | 11272488 | 6 | Adenocarcinoma of colon |
| 112724882 | 11272488 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112724882 | 11272488 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112724882 | 11272488 | Back pain | |
| 112724882 | 11272488 | Conjunctival haemorrhage | |
| 112724882 | 11272488 | Dry mouth | |
| 112724882 | 11272488 | Dysphonia | |
| 112724882 | 11272488 | Dysuria | |
| 112724882 | 11272488 | Erythema | |
| 112724882 | 11272488 | Haematuria | |
| 112724882 | 11272488 | Hyperkeratosis | |
| 112724882 | 11272488 | Hypertensive crisis | |
| 112724882 | 11272488 | Mastication disorder | |
| 112724882 | 11272488 | Neutropenia | |
| 112724882 | 11272488 | Onychoclasis | |
| 112724882 | 11272488 | Pain in jaw | |
| 112724882 | 11272488 | Paraesthesia | |
| 112724882 | 11272488 | Pharyngitis | |
| 112724882 | 11272488 | Pyrexia | |
| 112724882 | 11272488 | Stomatitis | |
| 112724882 | 11272488 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 112724882 | 11272488 | 1 | 20150102 | 0 | ||
| 112724882 | 11272488 | 2 | 20150102 | 0 | ||
| 112724882 | 11272488 | 3 | 20150102 | 0 | ||
| 112724882 | 11272488 | 4 | 20150102 | 0 | ||
| 112724882 | 11272488 | 5 | 20150102 | 0 | ||
| 112724882 | 11272488 | 6 | 20150102 | 20150609 | 0 | |
| 112724882 | 11272488 | 7 | 20150102 | 20150421 | 0 |