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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 783580260 | 7835802 | 60 | F | 20110214 | 20160913 | 20110301 | 20160921 | EXP | CA-ROCHE-GNE314169 | ROCHE | 52.64 | YR | F | Y | 54.48000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 783580260 | 7835802 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW (EVERY 2 WEEKS) | Y | U | S0059B,S0065E,S0068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | Y | U | S0059B,S0065E,S0068D | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW (EVERY 2 WEEKS) | Y | U | S0059B,S0065E,S0068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||
| 783580260 | 7835802 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | U | S0059B,S0065E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||
| 783580260 | 7835802 | 22 | SS | TRACLEER | BOSENTAN | 1 | Unknown | FOR 4 WEEKS | U | 0 | 62.5 | MG | TID | ||||||
| 783580260 | 7835802 | 23 | SS | TRACLEER | BOSENTAN | 1 | Unknown | 62.5 MG, BID FOR 3 WEEKS | U | 0 | 125 | MG | BID | ||||||
| 783580260 | 7835802 | 24 | SS | TRACLEER | BOSENTAN | 1 | Unknown | FOR3 WEEKS | U | 0 | 62.05 | MG | BID | ||||||
| 783580260 | 7835802 | 25 | SS | WARFARIN | WARFARIN | 1 | Unknown | 2 MG, QD | U | 0 | 2 | MG | QD | ||||||
| 783580260 | 7835802 | 26 | SS | WARFARIN | WARFARIN | 1 | Unknown | 7 MG, QD | U | 0 | 7 | MG | QD | ||||||
| 783580260 | 7835802 | 27 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | QD | U | 0 | QD | ||||||||
| 783580260 | 7835802 | 28 | C | THEOPHYLLINE | THEOPHYLLINE ANHYDROUS | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 29 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 783580260 | 7835802 | 30 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 31 | C | AVALOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | Unknown | UNK, QD | Y | 0 | QD | ||||||||
| 783580260 | 7835802 | 32 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 33 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 783580260 | 7835802 | 34 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 35 | C | MIDODRINE | MIDODRINE | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 36 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 783580260 | 7835802 | 37 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 783580260 | 7835802 | 38 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 783580260 | 7835802 | 39 | C | FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 1 | 0 | ||||||||||||
| 783580260 | 7835802 | 40 | C | AMOXICILLINE | AMOXICILLIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 783580260 | 7835802 | 1 | Asthma |
| 783580260 | 7835802 | 22 | Pulmonary hypertension |
| 783580260 | 7835802 | 23 | Cardiovascular disorder |
| 783580260 | 7835802 | 25 | Pulmonary hypertension |
| 783580260 | 7835802 | 26 | Anticoagulant therapy |
| 783580260 | 7835802 | 27 | Product used for unknown indication |
| 783580260 | 7835802 | 28 | Product used for unknown indication |
| 783580260 | 7835802 | 29 | Product used for unknown indication |
| 783580260 | 7835802 | 30 | Product used for unknown indication |
| 783580260 | 7835802 | 31 | Product used for unknown indication |
| 783580260 | 7835802 | 32 | Product used for unknown indication |
| 783580260 | 7835802 | 33 | Product used for unknown indication |
| 783580260 | 7835802 | 34 | Product used for unknown indication |
| 783580260 | 7835802 | 35 | Product used for unknown indication |
| 783580260 | 7835802 | 36 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 783580260 | 7835802 | HO |
| 783580260 | 7835802 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 783580260 | 7835802 | Anaemia | |
| 783580260 | 7835802 | Anxiety | |
| 783580260 | 7835802 | Asthma | |
| 783580260 | 7835802 | Blood pressure increased | |
| 783580260 | 7835802 | Breath sounds abnormal | |
| 783580260 | 7835802 | Candida infection | |
| 783580260 | 7835802 | Cardiovascular insufficiency | |
| 783580260 | 7835802 | Choking | |
| 783580260 | 7835802 | Chronic obstructive pulmonary disease | |
| 783580260 | 7835802 | Coagulopathy | |
| 783580260 | 7835802 | Cough | |
| 783580260 | 7835802 | Cystitis | |
| 783580260 | 7835802 | Dizziness | |
| 783580260 | 7835802 | Dyspnoea | |
| 783580260 | 7835802 | Dyspnoea exertional | |
| 783580260 | 7835802 | Eczema | |
| 783580260 | 7835802 | Eye swelling | |
| 783580260 | 7835802 | Fatigue | |
| 783580260 | 7835802 | Fungal infection | |
| 783580260 | 7835802 | Gait disturbance | |
| 783580260 | 7835802 | Gastroenteritis viral | |
| 783580260 | 7835802 | Haematochezia | |
| 783580260 | 7835802 | Headache | |
| 783580260 | 7835802 | Heart rate increased | |
| 783580260 | 7835802 | Hypersensitivity | |
| 783580260 | 7835802 | Hypotension | |
| 783580260 | 7835802 | Influenza | |
| 783580260 | 7835802 | Lower respiratory tract infection | |
| 783580260 | 7835802 | Malaise | |
| 783580260 | 7835802 | Nasal congestion | |
| 783580260 | 7835802 | Nasopharyngitis | |
| 783580260 | 7835802 | Osteoporosis | |
| 783580260 | 7835802 | Oxygen saturation decreased | |
| 783580260 | 7835802 | Pain | |
| 783580260 | 7835802 | Pallor | |
| 783580260 | 7835802 | Pneumonia | |
| 783580260 | 7835802 | Pollakiuria | |
| 783580260 | 7835802 | Productive cough | |
| 783580260 | 7835802 | Pulmonary hypertension | |
| 783580260 | 7835802 | Pyrexia | |
| 783580260 | 7835802 | Rectal haemorrhage | |
| 783580260 | 7835802 | Respiratory distress | |
| 783580260 | 7835802 | Respiratory rate decreased | |
| 783580260 | 7835802 | Sinus congestion | |
| 783580260 | 7835802 | Skin induration | |
| 783580260 | 7835802 | Sputum discoloured | |
| 783580260 | 7835802 | Syncope | |
| 783580260 | 7835802 | Tooth abscess | |
| 783580260 | 7835802 | Weight decreased | |
| 783580260 | 7835802 | 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 |
|---|---|---|---|---|---|---|
| 783580260 | 7835802 | 1 | 20100607 | 0 | ||
| 783580260 | 7835802 | 2 | 20100702 | 0 | ||
| 783580260 | 7835802 | 3 | 20120105 | 0 | ||
| 783580260 | 7835802 | 4 | 20120105 | 0 | ||
| 783580260 | 7835802 | 5 | 20120313 | 0 | ||
| 783580260 | 7835802 | 6 | 20130930 | 0 | ||
| 783580260 | 7835802 | 7 | 20120227 | 0 | ||
| 783580260 | 7835802 | 8 | 20130221 | 0 | ||
| 783580260 | 7835802 | 9 | 20140120 | 201404 | 0 | |
| 783580260 | 7835802 | 10 | 20141027 | 0 | ||
| 783580260 | 7835802 | 11 | 20140120 | 0 | ||
| 783580260 | 7835802 | 12 | 20150105 | 0 | ||
| 783580260 | 7835802 | 13 | 20150119 | 0 | ||
| 783580260 | 7835802 | 14 | 20150820 | 0 | ||
| 783580260 | 7835802 | 15 | 20160531 | 0 | ||
| 783580260 | 7835802 | 16 | 20160614 | 0 | ||
| 783580260 | 7835802 | 17 | 20160802 | 0 | ||
| 783580260 | 7835802 | 18 | 20160802 | 0 | ||
| 783580260 | 7835802 | 19 | 20160816 | 0 | ||
| 783580260 | 7835802 | 20 | 20160830 | 0 | ||
| 783580260 | 7835802 | 21 | 20160913 | 0 | ||
| 783580260 | 7835802 | 31 | 20120604 | 0 |