One was a primary statistical principle required by recent regulatory guidelines evaluating the effect regardless of treatment adherence and the second was a statistical principle describing the effect if people had adhered to treatment and did not initiate rescue medication
In trials in type 2 diabetes, it is standard to make rescue medication
available to patients whose blood glucose levels are not adequately controlled with the study treatment.
Statistical significance was achieved for the primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication
compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications
compared to placebo with both INVELTYS and KPI-121 0.
Secondary endpoints included no emesis, no rescue medication
, and no significant nausea (NSN:
5% of patients using the device were pain free at 15 minutes after the onset of pain from cluster headache, with no use of rescue medication
through the 30-minute treatment period, which was significantly greater than for placebo (6.
METHODS: Chiropractic and long acting beta agonists were compared in non-pulmonary function measurements including quality of life scores and changes in rescue medication
The dual-bronchodilator combination was also superior to salmeterol-fluticasone when it came to other outcomes, such as respiratory-related health status and rescue medication
use, and it had a good safety profile.
pivotal trial was the total combined rhinitis score (TCRS), which is the sum of the daily rhinitis symptom score and the daily rescue medication
usage score averaged over the last 8 weeks of the year-long study.
Secondary outcomes includes timing and episodes of rescue medication
consumption, post operative nausea \vomiting and bleeding.
If people on Probuphine might need occasional rescue medication
, this public health aim might be largely unmet.
At the end of run-in period, the baseline symptoms and signs of asthma, PFT, amount of rescue medication
and nocturnal awakening due to asthma symptoms were recorded.
A "well day" was considered as a day with no use of open-label rescue medication
and in which the worst score recorded was "none" or "mild" for each of the four nasal and two ocular symptoms measured.