At that time, if no clinical improvement was observed, using the criteria specified before, dose was increased to 10 mg/day.
or an objective response) were allowed to continue treatment with BelCaP at the before dose level, if toxicity had resolved to less than grade II (except for alopecia).
In general, there was no clear benefit of dose increase, with the exception of possible further improvement in the PASI score (median of 22% improvement in PASI score 12 weeks after dose escalation compared with before dose escalation).
OPA GMTs increased for all serotypes after dose 1 of PCV13 in the overall population with statistically significant increases in OPA GMTs observed for all serotypes after dose 1 compared with before dose 1 (Table 3 and Fig. 1b).
There was an increase in IgG GMCs for all serotypes after dose 1 of PCV13 in the overall population with statistically significant increases in GMCs observed for all serotypes after dose 1 compared with before dose 1 (Table 2 and Fig. 1a).
In general, after dose 1 compared with before dose 1, GMFRs were numerically similar between age groups, with a few exceptions; GMFRs for serotypes 4, 18C, 19F and 23F were numerically higher in the 6 to 17-year age group than in the at least 18-year age group, whereas the GMFR for serotype 7F was numerically lower in the 6 to 17-year age group than in the at least 18-year age group.
Although the near-tissue equivalence of diamond allows the direct measurement of dose for clinical applications without the need for energy-corrections, it is often cited that diamond detectors require pre-irradiation, a procedure necessary to stabilize the response or sensitivity of a diamond detector before dose measurements.
Antibodies against CSP were measured before dose one and 30 days after dose three and IFAT and spleen size (Hackett's scale) were measured at screening.
