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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127106411 | 12710641 | 1 | I | 2001 | 20160818 | 20160902 | 20160902 | EXP | US-SHIRE-US201610636 | SHIRE | 71.11 | YR | F | Y | 91.16000 | KG | 20160902 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127106411 | 12710641 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 250 MG (NINE CAPSULES), UNKNOWN (PER DAY) | 20049 | 250 | MG | CAPSULE | |||||||
| 127106411 | 12710641 | 2 | SS | PENTASA | MESALAMINE | 1 | Oral | 250 MG, UNKNOWN (1-2 PER DAY) | 20049 | 250 | MG | CAPSULE | |||||||
| 127106411 | 12710641 | 3 | SS | PENTASA | MESALAMINE | 1 | Oral | 250 MG (THREE CAPSULES), UNKNOWN (PER DAY) | 20049 | 250 | MG | CAPSULE | |||||||
| 127106411 | 12710641 | 4 | SS | PENTASA | MESALAMINE | 1 | Oral | 4000 MG, 1X/DAY:QD | 20049 | 4000 | MG | CAPSULE | QD | ||||||
| 127106411 | 12710641 | 5 | SS | PENTASA | MESALAMINE | 1 | Oral | 2500 MG, 1X/DAY:QD | 20049 | 2500 | MG | CAPSULE | QD | ||||||
| 127106411 | 12710641 | 6 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | 300 MG, 1X/DAY:QD | 0 | 300 | MG | QD | |||||||
| 127106411 | 12710641 | 7 | C | KLONOPIN | CLONAZEPAM | 1 | Unknown | 2 MG, OTHER (AT NIGHT) | 0 | 2 | MG | ||||||||
| 127106411 | 12710641 | 8 | C | KLONOPIN | CLONAZEPAM | 1 | 0 | ||||||||||||
| 127106411 | 12710641 | 9 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 1 MG, OTHER (AT NIGHT) | 0 | 1 | MG | ||||||||
| 127106411 | 12710641 | 10 | C | XANAX | ALPRAZOLAM | 1 | Unknown | .025 MG, AS REQ'D | 0 | .025 | MG | ||||||||
| 127106411 | 12710641 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, OTHER (AT NIGHT) | 0 | 20 | MG | ||||||||
| 127106411 | 12710641 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 118.5 MG, OTHER (IN THE MORNING) | 0 | 118.5 | UG | ||||||||
| 127106411 | 12710641 | 13 | C | PROBIOTICS NOS | PROBIOTICS NOS | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 127106411 | 12710641 | 14 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | UNK, 1X/DAY:QD | 0 | QD | |||||||||
| 127106411 | 12710641 | 15 | C | VITAMINS NOS | VITAMINS | 1 | Unknown | UNK, UNKNOWN (EVERY DAY) | 0 | ||||||||||
| 127106411 | 12710641 | 16 | C | IRON /00023503/ | IRON | 1 | Unknown | UNK, UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127106411 | 12710641 | 1 | Colitis ulcerative |
| 127106411 | 12710641 | 6 | Neuropathy peripheral |
| 127106411 | 12710641 | 7 | Sleep disorder |
| 127106411 | 12710641 | 8 | Chronic fatigue syndrome |
| 127106411 | 12710641 | 9 | Sleep disorder |
| 127106411 | 12710641 | 10 | Product used for unknown indication |
| 127106411 | 12710641 | 11 | Gastric disorder |
| 127106411 | 12710641 | 12 | Product used for unknown indication |
| 127106411 | 12710641 | 13 | Product used for unknown indication |
| 127106411 | 12710641 | 14 | Product used for unknown indication |
| 127106411 | 12710641 | 15 | Product used for unknown indication |
| 127106411 | 12710641 | 16 | Haemorrhagic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127106411 | 12710641 | OT |
| 127106411 | 12710641 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127106411 | 12710641 | Alopecia | |
| 127106411 | 12710641 | Colitis ulcerative | |
| 127106411 | 12710641 | Decreased appetite | |
| 127106411 | 12710641 | Disability | |
| 127106411 | 12710641 | Drug ineffective | |
| 127106411 | 12710641 | Internal haemorrhage | |
| 127106411 | 12710641 | Melaena | |
| 127106411 | 12710641 | Stress | |
| 127106411 | 12710641 | Unevaluable event | |
| 127106411 | 12710641 | 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 |
|---|---|---|---|---|---|---|
| 127106411 | 12710641 | 1 | 2001 | 0 | ||
| 127106411 | 12710641 | 2 | 201408 | 0 | ||
| 127106411 | 12710641 | 3 | 201501 | 201605 | 0 | |
| 127106411 | 12710641 | 4 | 201605 | 201608 | 0 | |
| 127106411 | 12710641 | 5 | 201608 | 0 | ||
| 127106411 | 12710641 | 6 | 2001 | 201608 | 0 | |
| 127106411 | 12710641 | 7 | 2001 | 0 | ||
| 127106411 | 12710641 | 11 | 201606 | 0 | ||
| 127106411 | 12710641 | 16 | 2016 | 0 |