Adverse Reactions Events Labelling 
European Pharmaceutical Review
NOVEMBER 21, 2022
The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0
pharmaphorum
APRIL 1, 2021
This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.
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European Pharmaceutical Review
DECEMBER 16, 2022
In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. HOPE-B trial for etranacogene dezaparvovec.
Express Pharma
JUNE 2, 2023
This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. Pharmacovigilance and adverse event reporting: Traceability systems enable effective pharmacovigilance, which involves monitoring and reporting adverse drug reactions (ADRs) and safety concerns.
Digital Pharmacist
OCTOBER 24, 2022
Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Common adverse effects include serious or fatal respiratory failure, ischemic events, abdominal pain, nausea, and diarrhea, among others. .
Birth Control Pharmacist
SEPTEMBER 20, 2021
Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021.
LifeProNow
APRIL 9, 2023
These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients. of patients.
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