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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125397022 | 12539702 | 2 | F | 20160815 | 20160708 | 20160823 | PER | PHHY2015US088746 | SANDOZ | 0.00 | F | Y | 54.80000 | KG | 20160823 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125397022 | 12539702 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | Y | 0 | 300 | MG | |||||||
| 125397022 | 12539702 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EVERY 4 WEEKS | Y | 0 | 150 | MG | |||||||
| 125397022 | 12539702 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | SCHEDULED DOSE ON 13 MAY 2016 | Y | 0 | 150 | MG | |||||||
| 125397022 | 12539702 | 4 | PS | NAPROXEN. | NAPROXEN | 1 | Unknown | UNK | U | 74140 | |||||||||
| 125397022 | 12539702 | 5 | C | CETRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 125397022 | 12539702 | 6 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 7 | C | EPIPEN | EPINEPHRINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 8 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | Intramuscular | 1 G, QD | U | 0 | 1 | G | QD | ||||||
| 125397022 | 12539702 | 9 | C | METHYLPREDNISOLONE SODIUM PHOSPHATE | METHYLPREDNISOLONE SODIUM PHOSPHATE | 1 | Intramuscular | 125 MG, QD | U | 0 | 125 | MG | QD | ||||||
| 125397022 | 12539702 | 10 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | 2 DF, QD | U | 0 | 2 | DF | TABLET | QD | |||||
| 125397022 | 12539702 | 11 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Oral | 50 MG, Q6H | U | 0 | 50 | MG | Q6H | ||||||
| 125397022 | 12539702 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 0.5 MG, NIGHTLY | U | 0 | .5 | MG | |||||||
| 125397022 | 12539702 | 13 | C | CLARITIN | LORATADINE | 1 | Oral | 1 DF, UNK | U | 0 | 1 | DF | TABLET | ||||||
| 125397022 | 12539702 | 14 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Oral | 3 DF, QD | U | 0 | 3 | DF | TABLET | QD | |||||
| 125397022 | 12539702 | 15 | C | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | Intramuscular | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 16 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intramuscular | 125 MG, UNK | U | 0 | 125 | MG | |||||||
| 125397022 | 12539702 | 17 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 18 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 19 | C | PEPCID | FAMOTIDINE | 1 | Other | UNK | U | 0 | |||||||||
| 125397022 | 12539702 | 20 | C | CLARITINE | LORATADINE | 1 | Oral | 1 DF, UNK | U | 0 | 1 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125397022 | 12539702 | 1 | Asthma |
| 125397022 | 12539702 | 2 | Urticaria |
| 125397022 | 12539702 | 3 | Hypersensitivity |
| 125397022 | 12539702 | 4 | Product used for unknown indication |
| 125397022 | 12539702 | 5 | Product used for unknown indication |
| 125397022 | 12539702 | 6 | Product used for unknown indication |
| 125397022 | 12539702 | 7 | Product used for unknown indication |
| 125397022 | 12539702 | 8 | Product used for unknown indication |
| 125397022 | 12539702 | 9 | Product used for unknown indication |
| 125397022 | 12539702 | 10 | Product used for unknown indication |
| 125397022 | 12539702 | 11 | Product used for unknown indication |
| 125397022 | 12539702 | 12 | Product used for unknown indication |
| 125397022 | 12539702 | 13 | Product used for unknown indication |
| 125397022 | 12539702 | 14 | Product used for unknown indication |
| 125397022 | 12539702 | 15 | Product used for unknown indication |
| 125397022 | 12539702 | 16 | Product used for unknown indication |
| 125397022 | 12539702 | 17 | Product used for unknown indication |
| 125397022 | 12539702 | 18 | Product used for unknown indication |
| 125397022 | 12539702 | 19 | Product used for unknown indication |
| 125397022 | 12539702 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125397022 | 12539702 | OT |
| 125397022 | 12539702 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125397022 | 12539702 | Asthma | |
| 125397022 | 12539702 | Cardiac disorder | |
| 125397022 | 12539702 | Drug hypersensitivity | |
| 125397022 | 12539702 | Dyspnoea | |
| 125397022 | 12539702 | Ear pain | |
| 125397022 | 12539702 | Hypersensitivity | |
| 125397022 | 12539702 | Malaise | |
| 125397022 | 12539702 | Rash | |
| 125397022 | 12539702 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 125397022 | 12539702 | 3 | 20160413 | 0 |