Severity of local and solicited adverse events was compared using cumulative logit models with main effects for dose group and CPG, with each participant scored for maximum severity events as follows: severity = 0 (no AE observed), severity = 1 (mild), severity = 2 (moderate) and severity = 3 (severe).
Subjects were counted once for maximum severity of an event, preferred term and system organ class.
Score components include shock (0 to 4 points), clinical history (MI, stroke, angina; 0 to 2 points), age (0 to 3 points), ECG findings (0 to 3 points), congestive heart failure (0 to 3 points), and Charlson Comorbidity Index (0 to 6 points) for a maximum severity score of 21 points [ 19].
Local adverse events In the groups receiving antigen with ISA 51, 6 volunteers experienced severe local reaction, 4 experienced moderate local reaction, and 14 experienced mild reaction (maximum severity for each).
Mean maximum severity scores for EAE were done using the following grading criteria: Grade 1. limp tail; grade 2. limp tail and weak hind limbs; Grade 3. hind limb paralysis; Grade 4. fore limb paralysis; Grade 5. moribund; Grade 6. death.
A standard scoring system based upon redness and swelling of each paw (ranging from 0 to 4 for each paw, thus resulting in a possible maximum severity score of 16) was used for the assessment of disease severity.
Average severity was 2.6 for children and 2.4 for caregivers on a 1 to 4 scale (maximum severity).
The severity of headache days was determined by the maximum severity across all the headache reports for the day.
Figure 6e, f display the spatial distribution of statistics for extreme events, considering the maximum duration and the maximum severity of droughts in China.
OA severity was calculated according to the Quebec Workers Compensation Board Scalee for OA: 0% = low severity, 100% = maximum severity [ 23].
For patients who died during the study, we inserted the maximum severity rating of 10.
