Clinical Trial Results
Essential for patient safety
Publication of the results of clinical trials
The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and supplement the information published in association with the Swiss marketing authorisation for the respective medicinal products.
Acalabrutinib (Calquence), 100 mg hard capsules:
Swiss marketing authorization number: 67790
Date of Swiss marketing authorization: 04.03.2021
ELEVATE-TN (ACE-CL-007): A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
- EudraCT Nummer: 2014-005582-73
- ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02475681
ASCEND (ACE-CL-309): A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia
- EudraCT Nummer: 2015-004454-17
- ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02970318
Reporting side effects or adverse events
Tel.: +41 41 725 77 77
We need at least the following information:
- Which AstraZeneca drug was used?
- What event was observed?
- Who is affected? (Initials, sex, age of the patient)
- Contact details of the reporting person for further inquiries