Clinical study reports are written to compile data from clinical trials. A CSR can be 1500 pages long, but don't be intimidated. It has 3 data sections: demographics, efficacy, safety. All the rest of the CSR is supporting data to prove the 3 data sections. GSK posted some CSRs because they were accused of conspiracy. These are our textbooks for CSRs.
The FDA needs to know about every patient who took any amount of drug, every patient who enrolled in the trial. The ICH E3 was compiled by a committee as a guideline of how to prepare a clinical study report. It was published in 1996 and is still the reference guideline. Some drug companies use this guideline as a template.
Examine the CSRs on Paxil.TM Note how the adverse event language and analysis has been incorporated into the safety section of the CSR. Examine the efficacy section to see how efficacy (effectiveness) is analyzed.