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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127012422 | 12701242 | 2 | F | 20160818 | 20160831 | 20160831 | 20160906 | EXP | IN-ROCHE-1818416 | ROCHE | 46.00 | YR | M | Y | 0.00000 | 20160906 | MD | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127012422 | 12701242 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 150 MG, UNK | Y | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 127012422 | 12701242 | 2 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 150 MG, UNK | Y | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 127012422 | 12701242 | 3 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 150 MG, UNK | Y | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 127012422 | 12701242 | 4 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 300 MG, UNK | Y | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 127012422 | 12701242 | 5 | C | CETRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 127012422 | 12701242 | 6 | C | CETRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127012422 | 12701242 | 1 | Urticaria |
| 127012422 | 12701242 | 5 | Urticaria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127012422 | 12701242 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127012422 | 12701242 | Angioedema | |
| 127012422 | 12701242 | Chest pain | |
| 127012422 | 12701242 | Cyanosis | |
| 127012422 | 12701242 | Dyspnoea | |
| 127012422 | 12701242 | Headache | |
| 127012422 | 12701242 | Hypotension | |
| 127012422 | 12701242 | Myalgia | |
| 127012422 | 12701242 | Peripheral swelling | |
| 127012422 | 12701242 | Pulse volume decreased | |
| 127012422 | 12701242 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 127012422 | 12701242 | 1 | 20160523 | 0 | ||
| 127012422 | 12701242 | 2 | 20160619 | 0 | ||
| 127012422 | 12701242 | 3 | 20160716 | 0 | ||
| 127012422 | 12701242 | 4 | 20160818 | 20160818 | 0 | |
| 127012422 | 12701242 | 5 | 20160818 | 0 | ||
| 127012422 | 12701242 | 6 | 20160819 | 0 |