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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112149067 | 11214906 | 7 | F | 20141006 | 20160808 | 20150624 | 20160811 | EXP | CA-ROCHE-1596870 | ROCHE | 62.02 | YR | F | Y | 0.00000 | 20160811 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112149067 | 11214906 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0042B | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 112149067 | 11214906 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0042B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 112149067 | 11214906 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0042B | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 112149067 | 11214906 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0042B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 112149067 | 11214906 | 5 | SS | GLYCOPYRRONIUM BROMIDE | GLYCOPYRRONIUM | 1 | Other | U | 0 | 50 | MG | ||||||||
| 112149067 | 11214906 | 6 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 200 OT, UNK | 0 | ||||||||||
| 112149067 | 11214906 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | 100 UG, UNK | 0 | 100 | UG | ||||||||
| 112149067 | 11214906 | 8 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112149067 | 11214906 | 1 | Asthma |
| 112149067 | 11214906 | 5 | Product used for unknown indication |
| 112149067 | 11214906 | 6 | Product used for unknown indication |
| 112149067 | 11214906 | 7 | Product used for unknown indication |
| 112149067 | 11214906 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112149067 | 11214906 | OT |
| 112149067 | 11214906 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112149067 | 11214906 | Amyotrophic lateral sclerosis | |
| 112149067 | 11214906 | Arthralgia | |
| 112149067 | 11214906 | Asthenia | |
| 112149067 | 11214906 | Back pain | |
| 112149067 | 11214906 | Balance disorder | |
| 112149067 | 11214906 | Cerebrovascular accident | |
| 112149067 | 11214906 | Chest pain | |
| 112149067 | 11214906 | Condition aggravated | |
| 112149067 | 11214906 | Contusion | |
| 112149067 | 11214906 | Death | |
| 112149067 | 11214906 | Drug ineffective | |
| 112149067 | 11214906 | Dysphonia | |
| 112149067 | 11214906 | Dyspnoea | |
| 112149067 | 11214906 | Fall | |
| 112149067 | 11214906 | Fatigue | |
| 112149067 | 11214906 | Feeling hot | |
| 112149067 | 11214906 | Hypoaesthesia | |
| 112149067 | 11214906 | Infection | |
| 112149067 | 11214906 | Lung infection | |
| 112149067 | 11214906 | Malaise | |
| 112149067 | 11214906 | Memory impairment | |
| 112149067 | 11214906 | Muscle spasms | |
| 112149067 | 11214906 | Muscular weakness | |
| 112149067 | 11214906 | Nasopharyngitis | |
| 112149067 | 11214906 | Pain | |
| 112149067 | 11214906 | Pain in extremity | |
| 112149067 | 11214906 | Pallor | |
| 112149067 | 11214906 | Palpitations | |
| 112149067 | 11214906 | Rales | |
| 112149067 | 11214906 | Respiratory rate increased | |
| 112149067 | 11214906 | Sciatic nerve neuropathy | |
| 112149067 | 11214906 | Tooth infection | |
| 112149067 | 11214906 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 112149067 | 11214906 | 1 | 20141006 | 0 | ||
| 112149067 | 11214906 | 2 | 20141118 | 0 | ||
| 112149067 | 11214906 | 3 | 20150224 | 0 | ||
| 112149067 | 11214906 | 4 | 20150714 | 20150714 | 0 |