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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125972511 | 12597251 | 1 | I | 20160715 | 20160727 | 20160727 | EXP | US-AUROBINDO-AUR-APL-2016-09810 | AUROBINDO | 61.00 | YR | F | Y | 0.00000 | 20160727 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125972511 | 12597251 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 10 MG, UNK | U | U | 202050 | 10 | MG | ||||||
| 125972511 | 12597251 | 2 | I | OLANZAPINE. | OLANZAPINE | 1 | Oral | 10 MG, UNK | U | U | 202050 | 10 | MG | ||||||
| 125972511 | 12597251 | 3 | I | OLANZAPINE. | OLANZAPINE | 1 | Oral | 10 MG, UNK | U | U | 202050 | 10 | MG | ||||||
| 125972511 | 12597251 | 4 | I | LORAZEPAM. | LORAZEPAM | 1 | Oral | 2-3 TIMES DAILY | U | 0 | 1 | MG | |||||||
| 125972511 | 12597251 | 5 | I | LORAZEPAM. | LORAZEPAM | 1 | Oral | 2-3 TIMES DAILY | U | 0 | 1 | MG | |||||||
| 125972511 | 12597251 | 6 | I | LORAZEPAM. | LORAZEPAM | 1 | Oral | U | 0 | 1 | MG | ||||||||
| 125972511 | 12597251 | 7 | I | LORAZEPAM. | LORAZEPAM | 1 | Intravenous (not otherwise specified) | U | 0 | 1 | MG | ||||||||
| 125972511 | 12597251 | 8 | C | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2000 MG/M2 OVER 46 HOURS | U | 0 | 2000 | MG/M**2 | |||||||
| 125972511 | 12597251 | 9 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 60 MG/M2 OVER 2 HOURS | U | 0 | 60 | MG/M**2 | |||||||
| 125972511 | 12597251 | 10 | C | FOLINIC ACID | LEUCOVORIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125972511 | 12597251 | 1 | Prophylaxis of nausea and vomiting |
| 125972511 | 12597251 | 2 | Nausea |
| 125972511 | 12597251 | 4 | Nausea |
| 125972511 | 12597251 | 5 | Anxiety |
| 125972511 | 12597251 | 6 | Premedication |
| 125972511 | 12597251 | 8 | Pancreatic carcinoma |
| 125972511 | 12597251 | 9 | Pancreatic carcinoma |
| 125972511 | 12597251 | 10 | Pancreatic carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125972511 | 12597251 | HO |
| 125972511 | 12597251 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125972511 | 12597251 | Delirium | |
| 125972511 | 12597251 | Drug interaction | |
| 125972511 | 12597251 | Hypotension | |
| 125972511 | 12597251 | Off label use | |
| 125972511 | 12597251 | Respiratory depression | |
| 125972511 | 12597251 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |