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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125013062 | 12501306 | 2 | F | 20160628 | 20160627 | 20160707 | EXP | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201603-001191 | CONCORDIA | 47.00 | YR | F | Y | 0.00000 | 20160706 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125013062 | 12501306 | 1 | PS | Atropine Sulphate | ATROPINE SULFATE | 1 | Subcutaneous | 250 MICROGRAM, UNK | U | U | 0 | 250 | UG | ||||||
| 125013062 | 12501306 | 2 | SS | Ondansetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG | ||||||
| 125013062 | 12501306 | 3 | SS | Ondansetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 | 8 | MG | ||||||
| 125013062 | 12501306 | 4 | SS | Calcium | CALCIUM | 1 | UNK | U | U | 0 | |||||||||
| 125013062 | 12501306 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | U | 0 | ||||||||||
| 125013062 | 12501306 | 6 | SS | DEXAMETHASON | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | U | U | 0 | 6.6 | MG | INJECTION | ||||||
| 125013062 | 12501306 | 7 | SS | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 350 MG, UNK | U | U | 0 | 350 | MG | ||||||
| 125013062 | 12501306 | 8 | SS | EMEND | APREPITANT | 1 | Oral | 125 MG, UNK | U | U | 0 | 125 | MG | CAPSULE | |||||
| 125013062 | 12501306 | 9 | SS | EMEND | APREPITANT | 1 | Oral | UNK | U | U | 0 | 125 | MG | CAPSULE | |||||
| 125013062 | 12501306 | 10 | SS | IRINOTECAN HYDROCHLORIDE. | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125013062 | 12501306 | 1 | Product used for unknown indication |
| 125013062 | 12501306 | 2 | Product used for unknown indication |
| 125013062 | 12501306 | 5 | Product used for unknown indication |
| 125013062 | 12501306 | 6 | Product used for unknown indication |
| 125013062 | 12501306 | 7 | Product used for unknown indication |
| 125013062 | 12501306 | 8 | Product used for unknown indication |
| 125013062 | 12501306 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125013062 | 12501306 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125013062 | 12501306 | Anorectal disorder | |
| 125013062 | 12501306 | Diarrhoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |