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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105529975 | 10552997 | 5 | F | 2012 | 20160822 | 20141029 | 20160901 | EXP | BR-ABBVIE-14P-020-1299627-00 | ABBVIE | 52.03 | YR | F | Y | 85.00000 | KG | 20160901 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105529975 | 10552997 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 105529975 | 10552997 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 105529975 | 10552997 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 105529975 | 10552997 | 4 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 105529975 | 10552997 | 5 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 105529975 | 10552997 | 6 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 105529975 | 10552997 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 120 | MG | TABLET | QD | |||||||
| 105529975 | 10552997 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 120 | MG | CAPSULE | ||||||||
| 105529975 | 10552997 | 9 | C | TRAMAL | TRAMADOL | 1 | Oral | 0 | TABLET | Q12H | |||||||||
| 105529975 | 10552997 | 10 | C | TRAMAL | TRAMADOL | 1 | Oral | 0 | 2 | DF | TABLET | ||||||||
| 105529975 | 10552997 | 11 | C | CELEBRA | CELECOXIB | 1 | Oral | 0 | 1 | DF | |||||||||
| 105529975 | 10552997 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 0 | 2 | DF | TABLET | ||||||||
| 105529975 | 10552997 | 13 | C | CATAFLAM | DICLOFENAC POTASSIUM | 1 | Topical | 0 | 3 | DF | OINTMENT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105529975 | 10552997 | 1 | Ankylosing spondylitis |
| 105529975 | 10552997 | 4 | Muscle relaxant therapy |
| 105529975 | 10552997 | 5 | Depression |
| 105529975 | 10552997 | 6 | Fibromyalgia |
| 105529975 | 10552997 | 7 | Gastritis |
| 105529975 | 10552997 | 8 | Gastritis prophylaxis |
| 105529975 | 10552997 | 9 | Pain |
| 105529975 | 10552997 | 11 | Pain |
| 105529975 | 10552997 | 12 | Sleep disorder therapy |
| 105529975 | 10552997 | 13 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105529975 | 10552997 | HO |
| 105529975 | 10552997 | OT |
| 105529975 | 10552997 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105529975 | 10552997 | Areflexia | |
| 105529975 | 10552997 | Arthralgia | |
| 105529975 | 10552997 | Blindness unilateral | |
| 105529975 | 10552997 | Bronchitis | |
| 105529975 | 10552997 | Cartilage injury | |
| 105529975 | 10552997 | Cataract | |
| 105529975 | 10552997 | Crying | |
| 105529975 | 10552997 | Cyst | |
| 105529975 | 10552997 | Drug ineffective | |
| 105529975 | 10552997 | Eye pain | |
| 105529975 | 10552997 | Gait disturbance | |
| 105529975 | 10552997 | Gastritis | |
| 105529975 | 10552997 | Headache | |
| 105529975 | 10552997 | Immunodeficiency | |
| 105529975 | 10552997 | Insomnia | |
| 105529975 | 10552997 | Irritability | |
| 105529975 | 10552997 | Memory impairment | |
| 105529975 | 10552997 | Muscle spasms | |
| 105529975 | 10552997 | Optic atrophy | |
| 105529975 | 10552997 | Osteoarthritis | |
| 105529975 | 10552997 | Osteoporosis | |
| 105529975 | 10552997 | Pain | |
| 105529975 | 10552997 | Photophobia | |
| 105529975 | 10552997 | Pneumonia | |
| 105529975 | 10552997 | Sinusitis | |
| 105529975 | 10552997 | Vitamin D deficiency | |
| 105529975 | 10552997 | 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 |
|---|---|---|---|---|---|---|
| 105529975 | 10552997 | 1 | 201204 | 0 | ||
| 105529975 | 10552997 | 2 | 2013 | 201506 | 0 | |
| 105529975 | 10552997 | 3 | 201508 | 0 | ||
| 105529975 | 10552997 | 4 | 2013 | 2013 | 0 | |
| 105529975 | 10552997 | 5 | 2013 | 0 | ||
| 105529975 | 10552997 | 7 | 201304 | 0 | ||
| 105529975 | 10552997 | 9 | 201304 | 0 | ||
| 105529975 | 10552997 | 11 | 2012 | 0 |