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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94991028 | 9499102 | 8 | F | 20160804 | 20160914 | 20130904 | 20160921 | EXP | CA-ROCHE-1269734 | ROCHE | 62.59 | YR | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94991028 | 9499102 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0003C | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 94991028 | 9499102 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0003C | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 94991028 | 9499102 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 94991028 | 9499102 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0003C | 103976 | SOLUTION FOR INJECTION | ||||||||
| 94991028 | 9499102 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0003C | 103976 | SOLUTION FOR INJECTION | ||||||||
| 94991028 | 9499102 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0003C | 103976 | SOLUTION FOR INJECTION | ||||||||
| 94991028 | 9499102 | 7 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 94991028 | 9499102 | 8 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 2 DF,(2 PUFF) BID | U | 0 | 2 | DF | BID | ||||||
| 94991028 | 9499102 | 9 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | 2 DF, (2 PUFF) | U | 0 | 2 | DF | |||||||
| 94991028 | 9499102 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | ||||||||||
| 94991028 | 9499102 | 11 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | Unknown | 0.05 MG, QD | U | 0 | .05 | MG | QD | ||||||
| 94991028 | 9499102 | 12 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 18 UG, QD | U | 0 | 18 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94991028 | 9499102 | 1 | Asthma |
| 94991028 | 9499102 | 7 | Product used for unknown indication |
| 94991028 | 9499102 | 8 | Product used for unknown indication |
| 94991028 | 9499102 | 9 | Product used for unknown indication |
| 94991028 | 9499102 | 10 | Adrenal insufficiency |
| 94991028 | 9499102 | 11 | Product used for unknown indication |
| 94991028 | 9499102 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94991028 | 9499102 | HO |
| 94991028 | 9499102 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94991028 | 9499102 | Addison's disease | |
| 94991028 | 9499102 | Adrenal insufficiency | |
| 94991028 | 9499102 | Blood pressure decreased | |
| 94991028 | 9499102 | Headache | |
| 94991028 | 9499102 | Hypokinesia | |
| 94991028 | 9499102 | Influenza | |
| 94991028 | 9499102 | Lung infection | |
| 94991028 | 9499102 | Malaise | |
| 94991028 | 9499102 | Nasopharyngitis | |
| 94991028 | 9499102 | Respiratory rate decreased | |
| 94991028 | 9499102 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 94991028 | 9499102 | 1 | 20110204 | 201302 | 0 | |
| 94991028 | 9499102 | 2 | 20130828 | 20130828 | 0 | |
| 94991028 | 9499102 | 3 | 20160721 | 0 | ||
| 94991028 | 9499102 | 4 | 20160804 | 0 | ||
| 94991028 | 9499102 | 5 | 20160831 | 0 | ||
| 94991028 | 9499102 | 6 | 20160914 | 0 |