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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118165217 | 11816521 | 7 | F | 201412 | 20160919 | 20151210 | 20160926 | EXP | BR-ROCHE-1229804 | ROCHE | 53.96 | YR | F | Y | 64.00000 | KG | 20160926 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118165217 | 11816521 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 150 | MG | SOLUTION FOR INJECTION | /month | ||||||
| 118165217 | 11816521 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 150 | MG | SOLUTION FOR INJECTION | /month | ||||||
| 118165217 | 11816521 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 150 | MG | SOLUTION FOR INJECTION | /month | ||||||
| 118165217 | 11816521 | 4 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | BID | U | 0 | BID | ||||||||
| 118165217 | 11816521 | 5 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 118165217 | 11816521 | 6 | C | PRELONE | PREDNISOLONE | 1 | Unknown | UNK | 0 | 500 | MG | ||||||||
| 118165217 | 11816521 | 7 | C | DAXAS | ROFLUMILAST | 1 | Unknown | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 118165217 | 11816521 | 8 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | 0 | ||||||||||
| 118165217 | 11816521 | 9 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 118165217 | 11816521 | 10 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | 0 | |||||||||||
| 118165217 | 11816521 | 11 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 118165217 | 11816521 | 12 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Unknown | 6 MG, UNK | 0 | 6 | MG | TABLET | |||||||
| 118165217 | 11816521 | 13 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Unknown | 16 MG | 0 | 16 | MG | TABLET | |||||||
| 118165217 | 11816521 | 14 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 118165217 | 11816521 | 15 | C | VELIJA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 2 DF, BID | 0 | 100 | MG | TABLET | BID | ||||||
| 118165217 | 11816521 | 16 | C | VANNAIR | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Oral | BID | U | 0 | TABLET | BID | |||||||
| 118165217 | 11816521 | 17 | C | CLENIL (BECLOMETASONE DIPROPIONATE) | BECLOMETHASONE DIPROPIONATE | 1 | Oral | BID | U | 0 | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118165217 | 11816521 | 1 | Asthma |
| 118165217 | 11816521 | 4 | Chronic obstructive pulmonary disease |
| 118165217 | 11816521 | 5 | Product used for unknown indication |
| 118165217 | 11816521 | 6 | Product used for unknown indication |
| 118165217 | 11816521 | 7 | Product used for unknown indication |
| 118165217 | 11816521 | 8 | Product used for unknown indication |
| 118165217 | 11816521 | 9 | Product used for unknown indication |
| 118165217 | 11816521 | 10 | Product used for unknown indication |
| 118165217 | 11816521 | 11 | Depression |
| 118165217 | 11816521 | 12 | Hypertension |
| 118165217 | 11816521 | 14 | Product used for unknown indication |
| 118165217 | 11816521 | 15 | Depression |
| 118165217 | 11816521 | 16 | Asthma |
| 118165217 | 11816521 | 17 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118165217 | 11816521 | OT |
| 118165217 | 11816521 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118165217 | 11816521 | Abdominal distension | |
| 118165217 | 11816521 | Anti-neutrophil cytoplasmic antibody positive vasculitis | |
| 118165217 | 11816521 | Asthenia | |
| 118165217 | 11816521 | Cerebrovascular accident | |
| 118165217 | 11816521 | Cushingoid | |
| 118165217 | 11816521 | Drug ineffective | |
| 118165217 | 11816521 | Fatigue | |
| 118165217 | 11816521 | Hypersensitivity | |
| 118165217 | 11816521 | Malaise | |
| 118165217 | 11816521 | Megacolon | |
| 118165217 | 11816521 | Osteoporosis | |
| 118165217 | 11816521 | Pain in extremity | |
| 118165217 | 11816521 | Pneumonia | |
| 118165217 | 11816521 | Sjogren's syndrome | |
| 118165217 | 11816521 | Spirometry abnormal | |
| 118165217 | 11816521 | Weight decreased | |
| 118165217 | 11816521 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 118165217 | 11816521 | 1 | 20130520 | 0 | ||
| 118165217 | 11816521 | 2 | 20130617 | 0 | ||
| 118165217 | 11816521 | 3 | 20131105 | 20160222 | 0 | |
| 118165217 | 11816521 | 17 | 201603 | 0 |