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The SAEs of emergent mania led to study discontinuation in two patients in the add-on lithium and six patients in the add-on placebo group.
Severe skin reactions occurred more frequently with chlorhexidine-alcohol (27 [2.6%] versus 7 [0.7%] patients; p = 0.0017), and led to chlorhexidine discontinuation in two patients.
EKG changes have been considered as cardiac serious adverse event (SAE) in the four (14%) patients with heart block inducing verapamil discontinuation in two patients and a dose reduction in one patient.
Increased alanine aminotransferase and EPS each led to discontinuation in two subjects; all other AEs that led to discontinuation were reported in one subject each.
Adverse events led to premature discontinuation in two patients receiving milnacipran (one with nausea and vomiting and one with increased heart rate and hypertension) and no patients receiving placebo.
The ΔmTSS >0.5 was observed within the first year of ADA discontinuation in two patients, so that their radiographic progression was determined by linearly extrapolating changes using their radiographic scores at exacerbation (data not shown).
Similar(53)
Hematologic toxicity was significant in the post-XRT consolidation phase, resulting in dose reduction and/or discontinuation in three of four patients.
Early disease progression was the cause of treatment discontinuation in three PET and four ET patients.
Dry mouth resulted in drug discontinuation in four tolvaptan and none of the placebo patients.
Rash led to discontinuation in five (1.4%) pirfenidone-treated patients and no placebo-treated patients [ 15].
Nineteen treatment-emergent adverse events occurred and, although mostly mild to moderate, resulted in treatment discontinuation in seven patients.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com