CLINICAL STUDY SUMMARY REPORT

TEMPLATE

CLINICAL STUDY SUMMARY

STUDY NO.	CT REGISTRY ID NO.
BASED ON CLINICAL STUDY REPORT REFERENCE CODE
PROPRIETARY DRUG NAME
INTERNATIONAL NONPROPRIETARY NAME (INN)
THERAPEUTIC AREA AND INDICATION(S)
SPONSOR(S)
STUDY TITLE
INVESTIGATOR(S) NUMBER
STUDY CENTER NUMBER(S)
LENGTH OF STUDY	DATE FIRST PARTICIPANT ENROLLED	DATE LAST PARTICIPANT COMPLETED
DEVELOPMENT PHASE

STUDY NO.	CT REGISTRY ID NO.
ABSTRACT Include primary objective, primary effectiveness, secondary efficacy variables, overall efficacy, methodology, safety information, participate information, and route, dose, and drug administration.

NUMBER OF SUBJECTS	OLD (DRUG)	TESTED (DRUG)
Planned (N)
Randomized (N)
Intention to treat population (N)
Completed (N), %
Withdrawn (N), %
Withdrawn for adverse effects (AEs) (N), %
Withdrawn due to lack of efficacy (N), %
Withdrawn due to lost to follow-up (N), %
Withdrawal of consent for personal reasons not related to AEs or lack of efficacy (N), %
Withdrawn for other reasons (list) (N), %

STUDY NO.	CT REGISTRY ID NO.

DEMOGRAPHY	OLD (DRUG)	TESTED (DRUG)
GENDER
Males
Females
Other gender category
Other gender category
AGE (years), MEAN (SD)
RACE / ETHNICITY, (N), %
White
Black / African American
Asian
Native Hawaiian / Pacific Islander
Hispanic/Latino
American Indian / Alaskan Native
Other

STUDY NO.	CT REGISTRY ID NO.
PRIMARY OUTCOMES
SECONDARY OUTCOMES
SAFETY OUTCOMES
REFERENCES
DATE OF REPORT

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