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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127653591 | 12765359 | 1 | I | 20121109 | 20160907 | 20160921 | 20160921 | EXP | US-ROCHE-1827734 | ROCHE | 45.00 | YR | F | Y | 195.40000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127653591 | 12765359 | 1 | PS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | RESTARTED AT A DOSE OF 0.5 MG | D | 17533 | TABLET | BID | |||||||
| 127653591 | 12765359 | 2 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | D | 17533 | |||||||||||
| 127653591 | 12765359 | 3 | SS | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Oral | D | 0 | 15 | MG | BID | |||||||
| 127653591 | 12765359 | 4 | SS | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | D | 0 | |||||||||||
| 127653591 | 12765359 | 5 | SS | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | D | 0 | |||||||||||
| 127653591 | 12765359 | 6 | SS | VISTARIL | HYDROXYZINE PAMOATE | 1 | Oral | D | 0 | 25 | MG | BID | |||||||
| 127653591 | 12765359 | 7 | SS | VISTARIL | HYDROXYZINE PAMOATE | 1 | D | 0 | |||||||||||
| 127653591 | 12765359 | 8 | SS | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 7.5MG/500MG | D | 0 | BID | ||||||||
| 127653591 | 12765359 | 9 | SS | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | D | 0 | |||||||||||
| 127653591 | 12765359 | 10 | SS | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | D | 0 | |||||||||||
| 127653591 | 12765359 | 11 | C | MOBIC | MELOXICAM | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 12 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | 0 | GEL | ||||||||||
| 127653591 | 12765359 | 13 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 14 | C | ABILIFY | ARIPIPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 15 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 16 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 17 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 18 | C | ROBAXIN | METHOCARBAMOL | 1 | Unknown | 0 | |||||||||||
| 127653591 | 12765359 | 19 | SS | NAPROXEN. | NAPROXEN | 1 | Oral | 375 MG TO 500 MG | D | 17581 | TABLET | ||||||||
| 127653591 | 12765359 | 20 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | D | 0 | BID | |||||||||
| 127653591 | 12765359 | 21 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | D | 0 | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127653591 | 12765359 | 1 | Anxiety |
| 127653591 | 12765359 | 2 | Insomnia |
| 127653591 | 12765359 | 3 | Back pain |
| 127653591 | 12765359 | 4 | Arthralgia |
| 127653591 | 12765359 | 5 | Neck pain |
| 127653591 | 12765359 | 6 | Nausea |
| 127653591 | 12765359 | 7 | Vomiting |
| 127653591 | 12765359 | 8 | Back pain |
| 127653591 | 12765359 | 9 | Arthralgia |
| 127653591 | 12765359 | 10 | Neck pain |
| 127653591 | 12765359 | 19 | Osteoarthritis |
| 127653591 | 12765359 | 20 | Osteoarthritis |
| 127653591 | 12765359 | 21 | Osteoarthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127653591 | 12765359 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127653591 | 12765359 | Mental status changes | |
| 127653591 | 12765359 | Overdose | |
| 127653591 | 12765359 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 127653591 | 12765359 | 1 | 20120224 | 20121109 | 0 | |
| 127653591 | 12765359 | 3 | 20120225 | 20121109 | 0 | |
| 127653591 | 12765359 | 6 | 20121018 | 20121109 | 0 | |
| 127653591 | 12765359 | 8 | 20120225 | 20121109 | 0 | |
| 127653591 | 12765359 | 11 | 20120924 | 20121106 | 0 | |
| 127653591 | 12765359 | 12 | 20120924 | 20121106 | 0 | |
| 127653591 | 12765359 | 13 | 20121107 | 20121109 | 0 | |
| 127653591 | 12765359 | 14 | 20110208 | 0 | ||
| 127653591 | 12765359 | 15 | 20111105 | 0 | ||
| 127653591 | 12765359 | 16 | 20110718 | 0 | ||
| 127653591 | 12765359 | 17 | 20110613 | 20121109 | 0 | |
| 127653591 | 12765359 | 18 | 20110208 | 20121106 | 0 | |
| 127653591 | 12765359 | 19 | 20121107 | 20141107 | 0 | |
| 127653591 | 12765359 | 20 | 20121107 | 20141107 | 0 | |
| 127653591 | 12765359 | 21 | 20121107 | 20141107 | 0 |