The percentage of patients with treatment-emergent adverse events
that were determined by the investigators to be related to the study drug was lowest in the TAK-875 patients (7%, compared with 11% in the placebo group and 23% in the glimepiride group).
The overall number of non-serious treatment-emergent adverse events
However, the study, funded by Eli Lilly & Co., concluded that treatment-emergent adverse events
, including anorexia, nausea, somnolence, dizziness, and vomiting, were significantly more common among those taking atomoxetine.
Grade 3 or 4 treatment-emergent adverse events
, or TEAEs, occurred in 42 patients on the ripretinib arm compared to 19 on the placebo arm.
The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events
and severe adverse events and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram, and clinical laboratory parameters.
A total of 28.5% of patients receiving omadacycline reported drug-related treatment-emergent adverse events
, compared with 16.1% of the linezolid group.
The researchers found that 8.2 percent of patients reported treatment-emergent adverse events
(TEAEs), the most common were application site dermatitis, paresthesia, pain, and pruritus.
The primary objective of Study 311 was safety and tolerability, evaluated based on incidence of treatment-emergent adverse events
(TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs and ECG parameters.
There was no significant difference in the incidence of treatment-emergent adverse events
in either group.
The most frequently reported treatment-emergent adverse events
were headaches, nasopharyngitis, breast tenderness, upper respiratory tract infection, nausea, back pain, and abdominal pain.
Treatment-emergent adverse events
were similar in type and severity in both groups.