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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126538191 | 12653819 | 1 | I | 20160808 | 20160816 | 20160816 | EXP | AU-ALEMBIC PHARMACUETICALS LIMITED-2016SCAL000661 | ALEMBIC | 0.00 | Y | 0.00000 | 20160816 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126538191 | 12653819 | 1 | PS | CLONIDINE HYDROCHLORIDE. | CLONIDINE HYDROCHLORIDE | 1 | Oral | UNK UNK, BID | Y | 91368 | |||||||||
| 126538191 | 12653819 | 2 | SS | CLONIDINE. | CLONIDINE | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 126538191 | 12653819 | 3 | SS | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | UNK UNK, BID | 0 | INFUSION | |||||||||
| 126538191 | 12653819 | 4 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126538191 | 12653819 | 1 | Product used for unknown indication |
| 126538191 | 12653819 | 2 | Product used for unknown indication |
| 126538191 | 12653819 | 3 | Product used for unknown indication |
| 126538191 | 12653819 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126538191 | 12653819 | HO |
| 126538191 | 12653819 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126538191 | 12653819 | Delirium | |
| 126538191 | 12653819 | Drug withdrawal syndrome | |
| 126538191 | 12653819 | Hypertension | |
| 126538191 | 12653819 | Sinus tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |