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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110739516 | 11073951 | 6 | F | 20100703 | 20160707 | 20150429 | 20160714 | EXP | CA-ROCHE-1512211 | ROCHE | 52.57 | YR | M | Y | 0.00000 | 20160714 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110739516 | 11073951 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0059B,S0068D | 103976 | 375 | MG | QOW | |||||
| 110739516 | 11073951 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0059B,S0068D | 103976 | 375 | MG | QOW | |||||
| 110739516 | 11073951 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0068D | 103976 | ||||||||
| 110739516 | 11073951 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0068D | 103976 | ||||||||
| 110739516 | 11073951 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 110739516 | 11073951 | 6 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110739516 | 11073951 | 1 | Asthma |
| 110739516 | 11073951 | 5 | Product used for unknown indication |
| 110739516 | 11073951 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110739516 | 11073951 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110739516 | 11073951 | Alcohol intolerance | |
| 110739516 | 11073951 | Cough | |
| 110739516 | 11073951 | Dyspnoea | |
| 110739516 | 11073951 | Fatigue | |
| 110739516 | 11073951 | Gastrooesophageal reflux disease | |
| 110739516 | 11073951 | Haemoptysis | |
| 110739516 | 11073951 | Headache | |
| 110739516 | 11073951 | Hypertension | |
| 110739516 | 11073951 | Hypotension | |
| 110739516 | 11073951 | Miliaria | |
| 110739516 | 11073951 | Nasal congestion | |
| 110739516 | 11073951 | Nasopharyngitis | |
| 110739516 | 11073951 | Night sweats | |
| 110739516 | 11073951 | Presyncope | |
| 110739516 | 11073951 | Productive cough | |
| 110739516 | 11073951 | Pyrexia | |
| 110739516 | 11073951 | Wrist fracture |
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 |
|---|---|---|---|---|---|---|
| 110739516 | 11073951 | 1 | 20051024 | 0 | ||
| 110739516 | 11073951 | 2 | 20060816 | 0 | ||
| 110739516 | 11073951 | 3 | 20160218 | 0 | ||
| 110739516 | 11073951 | 4 | 20160623 | 0 |