Responder rates

The second-generation antidepressants, particularly RIMAs and SSRJs, are much less toxic ia overdose than the older TCAs and irreversible MAO inhibitors. However, similar to first-generation antidepressants, the therapeutic effect only becomes manifest after several weeks. Up to one-third of depressed patients are nonresponders. Ideally, an antidepressant would combine a more rapid onset of action with greater clinical efficacy and a higher responder rate, as well as even better tolerability. 

Most studies have consistently agreed that both, TS mRNA and TS protein expression do vary considerably among tumors and that the respond rate of various tumors towards 5-FU Ijased chemotherapy regimens are related to intratumoral TS mRNA and protein expression. Higher TS expression levels are generally associated with lower response rates and shorter overall survival (3,52,53). 

An open trial with 3-year follow up has been conducted in 36 patients with catastrophic childhood onset epilepsy (2). The overall responder rate (more than a 50% reduction in seizure frequency) fell with time 69% at 3 months, 66% at 6 months, 47% at 1 year, and 41% at the end of the study. The most frequent adverse effects were anorexia, weight loss, urinary retention, somnolence, nervousness, and insomnia. Other reported adverse effects include skin reactions (including Stevens-Johnson syndrome), various blood dyscrasias, hepatotoxicity, and systemic lupus erythematosus (3). 

Once the final model has been derived and the analysis has achieved a satisfactory conclusion, the pharmacometrician has to face the important task of communicating the results of the analysis to nonpharmacometricians. This involves translating the mathematical relationships of the model into a form that directly addresses issues that are relevant, for example, responder rates in various patient subpopulations or a suggestion for the design of the next study in a drug... 

Healthy volunteer vaccine responder rates in the peptide control group (66.7%) were comparable to those in the verum groups, but were lower than the maximum responder rates obtained, confirming that... 

Fig. 3.5 Vaccine responder rates in chronically infected hepatitis C virus (HCV) patients. Peptide/ poly-L-arginine (9/12 75%) versus control groups (3/12 25% in both).

H LA-class I (recognized by cytotoxic T cells) peptides. Analysis of the data up to and including those obtained at the second immunological check (Visit 11) performed 6 months after the last immunization revealed no important differences in immunological responder rates compared to the data obtained at Visits 1 to 10, indicating sustainability of the IC41-induced immune response. The study also disclosed that T cell immunity against the virus can be raised to a level not too different from that induced in healthy vaccines. Thus, immu-... 

Schmidt 1989 40 depressive syndromes (various aetiologies, HAMD >16) [ICD] Psychotonin M 3 x 30 drops 4 weeks A 28 patients per protocol (16 Hyp/12 Pic) R HAMD decrease in mean total score from 29.25 to 9.75 (placebo 29.5 to 19.5), p<0.001 (U-test) responder rate (decrease in total score >50% or total score <10) 63% (placebo 33%) STAI XI and X2 no significant inter-group differences Self-rating scale for psychophysical condition decrease in symptom severity significantly greater in active treatment group compared with placebo, p<0.05 (Chi-square test)... 

Hauer, Schmidt and Kuhn 1991 120 mild depression (HAMD 16-20) [ICD-9 304.4, 309.9] Psychotonin M 3 x 30 drops 6 weeks A 116 patients, i-e. randomized patients except 4 with HAMD <16 94 per protocol patients (Hyp 53, Pic 41) no statistical testing R HAMD decrease in mean total score from 21.6 to 8.9 (placebo 20.9 to 16.1) responder rates (decrease in total score 550% or total score 510) 65.9% (placebo 25%) Selfrating scale D-S decrease in mean total score from 11.7 to 4.9 (placebo 12.7 to 8.1) HAMA decrease in mean total score from 11.9 to 4.5 (placebo 12.1 to 8.2) Patients global judgement 51.7% "very much improved" (placebo 19.6%)... 

The WEE vaccine was similarly prepared using the B-ll or CM-4884) virus strain, and caused only mild clinical reactions when administered to WEE-naive individuals.177 Between 1976 and 1990, 359 laboratory workers were immunized with this vaccine. Long-term follow-up studies have indicated that administration of three doses of 0.5 mL subcutaneously on days 0, 7, and 28 results in a 50% responder rate (neutralization titer > 1 40) after the primary series. Only 20% of recipients maintain a titer for 1 year, although this level can be increased to 60% to 70% with additional booster immunizations.176... 

At least 50 percent of respondents rated their symptoms as moderate to severe in each of these categories ... 

Company name Distribution sheets Replied sheets Responding rate(%)... 

Figures 5.11 and 5.12 plot the exponential logarithm (loge) of 52-week sales (adjusted for differences in distribution and merchandising) versus weighed purchase intent (a transformation of the proportion of definitely would buy and probably would buy ) and liking (the proportion of respondents rating the product in the top three boxes on a 9-point hedonic scale). These metrics are fairly standard in volumetric research.

Respondents rate the combination, one combination at a time Can t game the test... 

Phase 3 studies (EXPLORE) were conducted in a similar manner to phase 2 (randomized, double-blind, etc.) on about 1500 patients with refractory partial-onset seizures currently taking one or more AEDs (Table 3). The first two studies (304 and 305) were dose escalating and assessed the efficacy and tolerability of 8 and 12 mg doses of perampanel. The third study (306) assessed 2,4, and 8 mg doses. Analysis of the data from all three studies indicated that addition of perampanel at 4, 8 or 12 mg/day reduced median 28-day seizure frequency by 23-29% versus placebo (13%). The responder rate was also higher with perampanel (29-35%) versus placebo (19%). The 2 mg/day dose failed to show any statistically significant differences compared to placebo. 

Study Dose (mg/day) completed (enrolled) Median % change in seizure frequency 8 days 50% responder rates... 

Across the three studies, the responder rate (the percentage of patients with seizure reduction of at least 50%) was 17-23% for patients randomized to 400 mg/day, 34-40% for those randomized to 800 mg/day, and 37-43% for those who took 1200 mg/day among placebo-treated patients the responder rate was 13-20% [139 143 ]. 

It is impractical and unfair to expect a small-scale research project like this to help meet all the PLOs, though certain components were found to register lower impact compared to the others. Take for instance PL06 with less than a quarter of the respondents rating the impact as being significant. Occupational health and safety issues were hardly pertinent to the project as it was essentially a conceptual model development study without any site visit or reconnaissance involved. 

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