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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120598748 | 12059874 | 8 | F | 20151105 | 20160712 | 20160210 | 20160725 | EXP | JP-ACTELION-A-CH2015-127125 | ACTELION | 41.00 | YR | A | M | Y | 0.00000 | 20160725 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120598748 | 12059874 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | 170 | MG | Y | U | 204410 | 10 | MG | TABLET | QD | ||
| 120598748 | 12059874 | 2 | SS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | 170 | MG | Y | U | 204410 | 10 | MG | TABLET | QD | ||
| 120598748 | 12059874 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, BID | U | U | 0 | 500 | MG | BID | |||||
| 120598748 | 12059874 | 4 | SS | SUVOREXANT. | SUVOREXANT | 1 | Oral | UNK | U | U | 0 | ||||||||
| 120598748 | 12059874 | 5 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 120598748 | 12059874 | 6 | C | OXYGEN. | OXYGEN | 1 | U | 0 | |||||||||||
| 120598748 | 12059874 | 7 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 120598748 | 12059874 | 8 | C | UBIDECARENONE | UBIDECARENONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120598748 | 12059874 | 1 | Pulmonary arterial hypertension |
| 120598748 | 12059874 | 3 | Seizure |
| 120598748 | 12059874 | 4 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120598748 | 12059874 | OT |
| 120598748 | 12059874 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120598748 | 12059874 | Alanine aminotransferase increased | |
| 120598748 | 12059874 | Altered state of consciousness | |
| 120598748 | 12059874 | Aspartate aminotransferase increased | |
| 120598748 | 12059874 | Blood alkaline phosphatase increased | |
| 120598748 | 12059874 | Epilepsy | |
| 120598748 | 12059874 | Hepatic function abnormal | |
| 120598748 | 12059874 | Hypoxia | |
| 120598748 | 12059874 | Malaise | |
| 120598748 | 12059874 | Oxygen saturation decreased | |
| 120598748 | 12059874 | Seizure | |
| 120598748 | 12059874 | Seizure anoxic |
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 |
|---|---|---|---|---|---|---|
| 120598748 | 12059874 | 1 | 20151026 | 20151106 | 0 | |
| 120598748 | 12059874 | 2 | 20151108 | 0 | ||
| 120598748 | 12059874 | 3 | 20160404 | 0 | ||
| 120598748 | 12059874 | 4 | 20160329 | 0 |