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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125474982 | 12547498 | 2 | F | 20150903 | 20160812 | 20160712 | 20160823 | EXP | JP-ROCHE-1791629 | ROCHE | 25.11 | YR | F | Y | 0.00000 | 20160823 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125474982 | 12547498 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 103976 | 450 | MG | SOLUTION FOR INJECTION | ||||||||
| 125474982 | 12547498 | 2 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 103976 | 450 | MG | SOLUTION FOR INJECTION | ||||||||
| 125474982 | 12547498 | 3 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 103976 | 450 | MG | SOLUTION FOR INJECTION | ||||||||
| 125474982 | 12547498 | 4 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 103976 | 450 | MG | SOLUTION FOR INJECTION | ||||||||
| 125474982 | 12547498 | 5 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 103976 | 450 | MG | SOLUTION FOR INJECTION | ||||||||
| 125474982 | 12547498 | 6 | C | FLUTIFORM | FLUTICASONE PROPIONATEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 500 UG, BID | 0 | 500 | UG | BID | |||||||
| 125474982 | 12547498 | 7 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 5 UG, QD | 0 | 5 | UG | QD | |||||||
| 125474982 | 12547498 | 8 | C | THEO-DUR | THEOPHYLLINE ANHYDROUS | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 125474982 | 12547498 | 9 | C | TULOBUTEROL | TULOBUTEROL | 1 | Transdermal | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 125474982 | 12547498 | 10 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 125474982 | 12547498 | 11 | C | ALLELOCK | OLOPATADINE HYDROCHLORIDE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 125474982 | 12547498 | 12 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 125474982 | 12547498 | 13 | C | SENNOSIDE | SENNOSIDES | 1 | Oral | 24 MG, UNK | 0 | 24 | MG | ||||||||
| 125474982 | 12547498 | 14 | C | AMITIZA | LUBIPROSTONE | 1 | Oral | 48 UG, UNK | 0 | 48 | UG | ||||||||
| 125474982 | 12547498 | 15 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Oral | 990 MG, UNK | 0 | 990 | MG | ||||||||
| 125474982 | 12547498 | 16 | C | REFLEX | MIRTAZAPINE | 1 | Oral | 45 MG, UNK | 0 | 45 | MG | ||||||||
| 125474982 | 12547498 | 17 | C | DESYREL | TRAZODONE HYDROCHLORIDE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 125474982 | 12547498 | 18 | C | SILECE | FLUNITRAZEPAM | 1 | Oral | 2 MG, UNK | 0 | 2 | MG | ||||||||
| 125474982 | 12547498 | 19 | C | QUETIAPINE. | QUETIAPINE | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 125474982 | 12547498 | 20 | C | BROTIZOLAM | BROTIZOLAM | 1 | Oral | 0.5 MG, UNK | 0 | .5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125474982 | 12547498 | 1 | Asthma |
| 125474982 | 12547498 | 6 | Asthma |
| 125474982 | 12547498 | 7 | Asthma |
| 125474982 | 12547498 | 8 | Asthma |
| 125474982 | 12547498 | 9 | Asthma |
| 125474982 | 12547498 | 10 | Asthma |
| 125474982 | 12547498 | 11 | Asthma |
| 125474982 | 12547498 | 12 | Gastrooesophageal reflux disease |
| 125474982 | 12547498 | 13 | Constipation |
| 125474982 | 12547498 | 14 | Constipation |
| 125474982 | 12547498 | 15 | Constipation |
| 125474982 | 12547498 | 16 | Depression |
| 125474982 | 12547498 | 17 | Schizophrenia |
| 125474982 | 12547498 | 18 | Insomnia |
| 125474982 | 12547498 | 19 | Schizophrenia |
| 125474982 | 12547498 | 20 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125474982 | 12547498 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125474982 | 12547498 | Asthma |
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 |
|---|---|---|---|---|---|---|
| 125474982 | 12547498 | 1 | 20150825 | 0 | ||
| 125474982 | 12547498 | 2 | 20150922 | 0 | ||
| 125474982 | 12547498 | 3 | 20151023 | 0 | ||
| 125474982 | 12547498 | 4 | 20151120 | 0 | ||
| 125474982 | 12547498 | 5 | 20151218 | 0 |