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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127618901 | 12761890 | 1 | I | 201605 | 20160906 | 20160920 | 20160920 | EXP | PHHY2016CA126899 | NOVARTIS | 18.45 | YR | F | Y | 0.00000 | 20160920 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127618901 | 12761890 | 1 | PS | TAFINLAR | DABRAFENIB MESYLATE | 1 | Oral | 150 MG, BID | 202806 | 150 | MG | BID | |||||||
| 127618901 | 12761890 | 2 | SS | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | 1 | Oral | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 127618901 | 12761890 | 3 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 8 MG, QD | 0 | 8 | MG | QD | |||||||
| 127618901 | 12761890 | 4 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 6 MG, UNK | 0 | 6 | MG | ||||||||
| 127618901 | 12761890 | 5 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 16 MG, UNK | 0 | 16 | MG | ||||||||
| 127618901 | 12761890 | 6 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 4 MG, TID | 0 | 4 | MG | TID | |||||||
| 127618901 | 12761890 | 7 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 127618901 | 12761890 | 8 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 127618901 | 12761890 | 9 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 8 MG, QD | 0 | 8 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127618901 | 12761890 | 1 | Ganglioglioma |
| 127618901 | 12761890 | 2 | Ganglioglioma |
| 127618901 | 12761890 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127618901 | 12761890 | HO |
| 127618901 | 12761890 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127618901 | 12761890 | Abdominal discomfort | |
| 127618901 | 12761890 | Abdominal pain | |
| 127618901 | 12761890 | Abdominal tenderness | |
| 127618901 | 12761890 | Adrenocortical insufficiency acute | |
| 127618901 | 12761890 | Alopecia | |
| 127618901 | 12761890 | Anxiety | |
| 127618901 | 12761890 | Arthralgia | |
| 127618901 | 12761890 | Ataxia | |
| 127618901 | 12761890 | Axillary pain | |
| 127618901 | 12761890 | Blood calcium decreased | |
| 127618901 | 12761890 | Blood lactate dehydrogenase increased | |
| 127618901 | 12761890 | Blood potassium decreased | |
| 127618901 | 12761890 | Chills | |
| 127618901 | 12761890 | Confusional state | |
| 127618901 | 12761890 | Constipation | |
| 127618901 | 12761890 | Cushingoid | |
| 127618901 | 12761890 | Diplopia | |
| 127618901 | 12761890 | Dizziness | |
| 127618901 | 12761890 | Drug ineffective | |
| 127618901 | 12761890 | Drug intolerance | |
| 127618901 | 12761890 | Dry skin | |
| 127618901 | 12761890 | Erythema | |
| 127618901 | 12761890 | Facial paralysis | |
| 127618901 | 12761890 | Fatigue | |
| 127618901 | 12761890 | Fluid retention | |
| 127618901 | 12761890 | Food craving | |
| 127618901 | 12761890 | Gait disturbance | |
| 127618901 | 12761890 | Gaze palsy | |
| 127618901 | 12761890 | Headache | |
| 127618901 | 12761890 | Hemiparesis | |
| 127618901 | 12761890 | Hepatic enzyme increased | |
| 127618901 | 12761890 | Hydrocephalus | |
| 127618901 | 12761890 | Hyperreflexia | |
| 127618901 | 12761890 | Hypotension | |
| 127618901 | 12761890 | Increased appetite | |
| 127618901 | 12761890 | Joint swelling | |
| 127618901 | 12761890 | Lymphadenopathy | |
| 127618901 | 12761890 | Malignant neoplasm progression | |
| 127618901 | 12761890 | Mood swings | |
| 127618901 | 12761890 | Myopathy | |
| 127618901 | 12761890 | Nervous system disorder | |
| 127618901 | 12761890 | Oedema peripheral | |
| 127618901 | 12761890 | Pain in extremity | |
| 127618901 | 12761890 | Palatal disorder | |
| 127618901 | 12761890 | Periarthritis | |
| 127618901 | 12761890 | Peripheral swelling | |
| 127618901 | 12761890 | Pyrexia | |
| 127618901 | 12761890 | Rebound effect | |
| 127618901 | 12761890 | Sensitisation | |
| 127618901 | 12761890 | Skin atrophy | |
| 127618901 | 12761890 | Skin striae | |
| 127618901 | 12761890 | Swelling | |
| 127618901 | 12761890 | Urinary tract infection | |
| 127618901 | 12761890 | Viral infection | |
| 127618901 | 12761890 | 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 |
|---|---|---|---|---|---|---|
| 127618901 | 12761890 | 1 | 20160324 | 2016 | 0 | |
| 127618901 | 12761890 | 2 | 20160324 | 2016 | 0 |