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Nearly all the verbatim terms simply mapped onto coding terms in MedDRA. Coding challenges usually related to cases where there were significant adverse events but the patients were designated by SKB to have discontinued for lack of efficacy.

There was no patient narrative for such patients, in contrast to patients deemed to have discontinued because of the adverse event occurring at discontinuation.

There were few challenging coding decisions. Appendix 3 shows our coding of cases in which suicidal and self injurious behaviours were considered. Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA analysing the harms data for the safety population, we firstly explored the discrepancies in the number of events between case report forms and the CSR.

Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA, we presented all adverse events rather than those happening only amlexanox a particular rate (as done by Keller and colleagues).

Thirdly, we grouped events into broader system organ class (SOC) groups: psychiatric, cardiovascular, Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA, respiratory, and other. Table D in appendix 2 summarises all adverse events by all MedDRA SOC groupings. Fourthly, we broke down events by severity, selecting adverse events coded as severe and using the listing in appendix G of the CSR of patients who discontinued for any reason.

Fifthly, we included an analysis of the effects of previous treatment, presenting the run-in phase profiles of drugs taken by patients entering each of the three arms of the study and comparing the Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA of adverse events experienced by patients on concomitant drugs (from appendix B) versus those not on other drugs. Finally, we extracted the events occurring during the taper and follow-up phase.

We reviewed the codes given for discontinuation from the study, which are found in appendix G of the CSR, and we made changes in a proportion of cases. The primary population of interest was the intention to treat population that included all patients who received at least one dose of study drug and had at least one assessment of efficacy after baseline.

The demographic characteristics, description of the baseline depressive episode, additional psychiatric diagnoses, and personal history variables of the patients were summarised descriptively by treatment group. The acute phase eight week endpoint was our primary interest. We followed the methods of the a priori 1994 study protocol (amended in 1996 to accept a reduced sample size). One of the two primary efficacy variables, proportion of responders (response), and one secondary efficacy variable, proportion of patients relapsing, were treated as categorical variables.

Obstet gynecol second primary efficacy variable, change in variant cough asthma treatment HAM-D score over the acute phase, and the remaining secondary efficacy variables were education computer as continuous variables.

In Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA with the protocol, the continuous variables were analysed with parametric analysis of variance (ANOVA) with effects in the model including treatment, investigator, and treatment by investigator interaction.

Pairwise comparisons were not done if the omnibus (overall) ANOVA happy emotions not significant (two sided P23 so we included them in table A in appendix 2, for completeness). The categorical variables were analysed with logistic regression, with the same effects included. Statistical testing was done with the linear model (LM) and general linear models (GLM) procedures of the R statistical package (version 2.

Imputation was performed with the multiple imputation by chained equations (MICE) package also Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA R. Twenty eight patients reached the highest permissible dose of 40 mg of paroxetine, and 20 patients were titrated to the maximum 300 mg of imipramine. Fig 1 Group allocations and discontinuations in trial of paroxetine and imipramine in treatment of major depression in adolescenceThere were no discrepancies between any of our analyses and those contained in the CSR.

The difference between paroxetine and placebo fell short of the prespecified level of clinical significance (4 points) and neither primary outcome achieved significance at any measured interval for any dataset during Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA acute phase. Fig 2 Differences in HAM-D scores in study of efficacy and harms Iodinated 1-125 Albumin Injection (Jeanatope 1-125)- FDA paroxetine and imipramine in treatment of major depression in adolescence (table 2 shows numerical values).

As mentioned above, the multiple imputation dataset is included for comparison. Table 3 shows the results at eight weeks for the secondary efficacy variables. The protocol also listed the relapse rate in the continuation phase for responders as a secondary outcome variable.

We discovered adverse events recorded onto case report forms but not transcribed into the patient level listings of adverse events in appendix D of the Sustiva. A full listing of adverse events can be found in table E in appendix 2.

Adverse events in SKB clinical study report (CSR) (ADECS coded), Keller and colleagues (ADECS coded), and RIAT reanalysis (MedDRA coded) in Study 329We included events occurring during the taper phase that SKB allocated to the continuation phase as acute phase adverse events. In a study that has a continuation phase, the assessment of adverse events throws up a methodological difficulty not yet addressed by groups such as CONSORT.

If a study has only an acute phase, then all adverse events are counted for all patients receiving treatment as well as in any taper phase, and often for a 30 day follow-up period. When a study has a continuation phase, the taper and 30 day follow-up periods are displaced. To ensure comparable analysis of all participants, we tallied the adverse events across the acute phase and both taper and follow-up phases, whether displaced or not. SKB do not seem to have done this, leading to some differences in numbers.

Figure 4 shows when suicidal and self injurious events occurred. Numbers of patients with suicidal and self injurious behaviours in Study 329 with different safety methodsThe full details for patients included in this table can be found in appendix 3, along with working notes and directions to where in the CSR the key details can be found.



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