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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116901607 | 11690160 | 7 | F | 20120712 | 20160905 | 20151102 | 20160915 | EXP | BR-ABBVIE-15K-020-1490982-00 | ABBVIE | 62.02 | YR | F | Y | 73.00000 | KG | 20160915 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116901607 | 11690160 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 48043XH04,51072XH01,62158XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116901607 | 11690160 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 48043XH04,51072XH01,62158XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | Q3W | ||||||
| 116901607 | 11690160 | 3 | SS | SAFFLOWER OIL | SAFFLOWER OIL | 1 | Oral | UNKNOWN | 0 | CAPSULE | |||||||||
| 116901607 | 11690160 | 4 | SS | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Oral | UNKNOWN | 0 | 300 | MG | TABLET | BID | ||||||
| 116901607 | 11690160 | 5 | C | LABIRIN | BETAHISTINE | 1 | Oral | 0 | 16 | MG | TABLET | BID | |||||||
| 116901607 | 11690160 | 6 | C | LABIRIN | BETAHISTINE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | .5 | MG | TABLET | BID | |||||||
| 116901607 | 11690160 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 10 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 0 | ||||||||||||
| 116901607 | 11690160 | 11 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 12 | C | MICARDIS | TELMISARTAN | 1 | Oral | FORM STRENGTH: 80MG/5M | 0 | TABLET | |||||||||
| 116901607 | 11690160 | 13 | C | GARDENAL | PHENOBARBITAL | 1 | Oral | 0 | 100 | MG | BID | ||||||||
| 116901607 | 11690160 | 14 | C | GARDENAL | PHENOBARBITAL | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 15 | C | GARDENAL | PHENOBARBITAL | 1 | Oral | 0 | 1 | DF | TABLET | Q12H | |||||||
| 116901607 | 11690160 | 16 | C | CONCARDIO | BISOPROLOL FUMARATE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 17 | C | CONCARDIO | BISOPROLOL FUMARATE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 18 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 19 | C | GINKGO BILOBA | GINKGO | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116901607 | 11690160 | 20 | C | GINKGO BILOBA | GINKGO | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 21 | C | GINKGO BILOBA | GINKGO | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116901607 | 11690160 | 22 | C | NIMESULIDE | NIMESULIDE | 1 | Oral | 0 | 1 | DF | TABLET | ||||||||
| 116901607 | 11690160 | 23 | C | NIMESULIDE | NIMESULIDE | 1 | 0 | ||||||||||||
| 116901607 | 11690160 | 24 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 25 | C | GARDENAL | PHENOBARBITAL | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 26 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 0 | 1 | DF | TABLET | Q6H | |||||||
| 116901607 | 11690160 | 27 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 0 | 2.5 | MG | TABLET | ||||||||
| 116901607 | 11690160 | 28 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 0 | TABLET | ||||||||||
| 116901607 | 11690160 | 29 | C | VERTIX | 2 | Oral | 0 | 1 | DF | TABLET | Q12H | ||||||||
| 116901607 | 11690160 | 30 | C | DORIL | 2 | Oral | 0 | TABLET | |||||||||||
| 116901607 | 11690160 | 31 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116901607 | 11690160 | 32 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 116901607 | 11690160 | 33 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116901607 | 11690160 | 1 | Rheumatoid arthritis |
| 116901607 | 11690160 | 3 | Blood cholesterol |
| 116901607 | 11690160 | 4 | Seizure |
| 116901607 | 11690160 | 5 | Labyrinthitis |
| 116901607 | 11690160 | 7 | Rheumatoid arthritis |
| 116901607 | 11690160 | 8 | Arthritis |
| 116901607 | 11690160 | 9 | Hypertension |
| 116901607 | 11690160 | 10 | Diuretic therapy |
| 116901607 | 11690160 | 11 | Hypertension |
| 116901607 | 11690160 | 12 | Hypertension |
| 116901607 | 11690160 | 13 | Seizure |
| 116901607 | 11690160 | 14 | Cerebral disorder |
| 116901607 | 11690160 | 15 | Hypertension |
| 116901607 | 11690160 | 16 | Hypertension |
| 116901607 | 11690160 | 17 | Cardiac disorder |
| 116901607 | 11690160 | 18 | Hypertension |
| 116901607 | 11690160 | 19 | Labyrinthitis |
| 116901607 | 11690160 | 20 | Hypertension |
| 116901607 | 11690160 | 22 | Pain in extremity |
| 116901607 | 11690160 | 23 | Rheumatoid arthritis |
| 116901607 | 11690160 | 24 | Cerebral disorder |
| 116901607 | 11690160 | 25 | Seizure |
| 116901607 | 11690160 | 26 | Arthropathy |
| 116901607 | 11690160 | 27 | Arthritis |
| 116901607 | 11690160 | 29 | Dizziness |
| 116901607 | 11690160 | 30 | Headache |
| 116901607 | 11690160 | 31 | Arthritis |
| 116901607 | 11690160 | 32 | Cardiac disorder |
| 116901607 | 11690160 | 33 | Cerebral disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116901607 | 11690160 | OT |
| 116901607 | 11690160 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116901607 | 11690160 | Abscess limb | |
| 116901607 | 11690160 | Activities of daily living impaired | |
| 116901607 | 11690160 | Arthralgia | |
| 116901607 | 11690160 | Arthritis | |
| 116901607 | 11690160 | Arthropathy | |
| 116901607 | 11690160 | Bone disorder | |
| 116901607 | 11690160 | Bursitis | |
| 116901607 | 11690160 | Coordination abnormal | |
| 116901607 | 11690160 | Crying | |
| 116901607 | 11690160 | Dizziness | |
| 116901607 | 11690160 | Feeling abnormal | |
| 116901607 | 11690160 | Grip strength decreased | |
| 116901607 | 11690160 | Hypertension | |
| 116901607 | 11690160 | Injection site pain | |
| 116901607 | 11690160 | Injury | |
| 116901607 | 11690160 | Joint range of motion decreased | |
| 116901607 | 11690160 | Joint swelling | |
| 116901607 | 11690160 | Labyrinthitis | |
| 116901607 | 11690160 | Limb mass | |
| 116901607 | 11690160 | Mobility decreased | |
| 116901607 | 11690160 | Muscle spasms | |
| 116901607 | 11690160 | Musculoskeletal pain | |
| 116901607 | 11690160 | Musculoskeletal stiffness | |
| 116901607 | 11690160 | Oedema peripheral | |
| 116901607 | 11690160 | Osteoarthritis | |
| 116901607 | 11690160 | Pain | |
| 116901607 | 11690160 | Pain in extremity | |
| 116901607 | 11690160 | Peripheral swelling | |
| 116901607 | 11690160 | Psychomotor skills impaired | |
| 116901607 | 11690160 | Rheumatoid arthritis | |
| 116901607 | 11690160 | Skin wrinkling | |
| 116901607 | 11690160 | Speech disorder | |
| 116901607 | 11690160 | Synovial disorder | |
| 116901607 | 11690160 | Tendonitis | |
| 116901607 | 11690160 | Tremor | |
| 116901607 | 11690160 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 116901607 | 11690160 | 1 | 20120712 | 0 | ||
| 116901607 | 11690160 | 4 | 2015 | 0 | ||
| 116901607 | 11690160 | 7 | 2012 | 0 | ||
| 116901607 | 11690160 | 9 | 2008 | 0 | ||
| 116901607 | 11690160 | 11 | 201508 | 0 | ||
| 116901607 | 11690160 | 12 | 201508 | 0 | ||
| 116901607 | 11690160 | 16 | 201510 | 0 | ||
| 116901607 | 11690160 | 17 | 2016 | 0 | ||
| 116901607 | 11690160 | 18 | 2008 | 0 | ||
| 116901607 | 11690160 | 19 | 1988 | 0 | ||
| 116901607 | 11690160 | 20 | 20151022 | 0 | ||
| 116901607 | 11690160 | 25 | 2006 | 0 | ||
| 116901607 | 11690160 | 26 | 2010 | 0 | ||
| 116901607 | 11690160 | 31 | 2012 | 0 |