An observational study in Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Observational
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 50 is below the median of 141 across 147 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Iclusig 45mg, 15mg
Also known as: Iclusig
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Time frame: until 14 days after last administration
The number of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive →
Korea Otsuka Pharmaceutical Co., Ltd. →