Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

Table 2 Content and characteristics of the trial documents

Trial ID	NM16189		M37013		M37002		M37047		BM15421
Safety primary objective of trial?	No†		No†		No¥		No¥		No†
Journal publication: author, journal and year	Chanoine [22], Journal of the American Medical Association (JAMA (2005)		Halpern [23], Diabetes, Obesity and Metabolism (2003)		Hanefeld [25], Diabetes, Obesity and Metabolism (2002)		Kelley [26], Diabetes Care (2002)		Torgerson [24], Diabetes Care (2004)
CSR research report no. (date of CSR)	1011426 (2003)		1002688 (2000)		1003882 (2001)		1002743 (2001)		1008213 (2002)
Word count (including text and numbers, but not tables)
Trial document	Pub	CSR	Pub	CSR	Pub	CSR	Pub	CSR	Pub	CSR
Total number of words in document^ϵ	10,568	146,801	6,371	45,464	6,382	140,166	7,090	170,347	5915	314,277
Total number of words relating to safety (% of total)	1,147 (10.9)	4,883 (3.3)	908 (14.3)	2,664 (5.9)	638 (10)	4,964 (3.5)	707 (10)	4,150 (2.4)	387 (6.5)	6,653 (2.1)
CSR Module^ɸ supplied by Roche
I	✓^Π		✓^Π		✓		✓^Π		✓^Π
II	✓		✓		✓		✓		*
III	*		*		*		*		*
IV	*		*		*		*		*
V	*		✓		✓		✓		✓

Footnote:
CSR Clinical study report, Pub Journal publication
†Safety secondary objective in both the CSR and journal publication; ¥Objective to assess improvements in glycaemic control and cardiovascular disease risk in both CSR and Journal publication; ^ɸ Module: I = Core report (background and rationale, objectives, materials and methods, efficacy results, safety results, discussion, conclusion and appendices); II = Study documents (protocol and amendments history, black case report form (CRF), subject information sheet and consent form, glossaries of original and preferred terms, randomization list, reporting analysis plan (RAP), certificates of analysis, list of investigators, list of ethics committee members); III = Listing of demographic and efficacy data; IV = Listing of safety data; V = Statistical reports and appendices (Statistical analysis, efficacy results). ✓Module provided in CSR; *Roche did not provide these modules, since they contained individual patient data listings and therefore were deleted. ϵ We could only count words for modules that were made available by Roche, so the actual number would be greater than this. The percentage of words relating to harms would therefore differ; ^Π CSRs each had one missing page in module I, which Roche provided upon further requests. Any additional information from this was used in the results.

ISSN: 1745-6215