. Author manuscript; available in PMC: 2015 Mar 12.

Published in final edited form as: JAMA. 2014 Mar 12;311(10):1063–1065. doi: 10.1001/jama.2013.285634

Table 2.

Discordant primary efficacy endpoint results reported on ClinicalTrials.gov and in corresponding publication that altered trial interpretation (n=6).

Trial ID	Primary Efficacy Outcome		Explanation for Why Trial Interpretation was Altered
Trial ID	ClinicalTrials.gov Reported Results	Publication Reported Results	Explanation for Why Trial Interpretation was Altered
NCT00094887	Median Hours to Resolution of Vaso-occlusive Pain Crisis (95% CI)		Time to resolution in both groups was substantially shorter on ClinicalTrials.gov than in publication.
NCT00094887	Inhaled Nitric Oxide: 61.83, 95% CI: (41.75, 78.00); Placebo: 55.16, 95% CI: (46.00, 72.00); No statistical analysis provided.	Inhaled Nitric Oxide: 73.0, 95% CI: (46.0, 91.0); Placebo: 65.5, 95% CI: (48.1, 84.0); P = 0.87
NCT00108953	Median Time to Progression (95% CI)		Median time to progression in both groups was substantially longer on ClinicalTrials.gov than in publication.
NCT00108953	Sorafenib + Doxorubicin: 263 days, 95% CI: (146, 384); Placebo + Doxorubicin: 147 days, 95% CI: (66, 244); P = 0.016	Sorafenib + Doxorubicin: 6.4 months, 95% CI: (4.8, 9.2); Placebo + Doxorubicin: 2.8 months, 95% CI: (1.6, 5); P = 0.02
NCT00177671	Number of Participants With Recurrence of Major Depression		Percentage of participants with major depression recurrence was lower on ClinicalTrials.gov than in publication and hazard ratio on ClinicalTrials.gov is 2-fold greater.
NCT00177671	Donepezil: 19/67, 95% CI: (16, 31); Placebo: 11/63, 95% CI: (6, 18); HR=3.97, SD=2.09, 95% CI: (1.00, 4.41); P=0.05	Donepezil: 35%; 95% CI: (24%, 46%); Placebo: 19%, 95% CI: (9%, 29%); HR=2.09, 95% CI: (1.00, 4.41), λ²=3.97; P=0.05
NCT00281918	Progression-Free Survival, median		Progression-Free Survival was substantially shorter in the rituximab substantially shorter in the rituximab arm reported on ClinicalTrials.gov than in publication.
NCT00281918	Fludarabine/Cyclophosphamide: 981.0 days, Range: (1, 1343); Fludarabine/Cyclophosphamide/Rituximab: 1212.0 days, Range: (1, 1372); P<0.0001	Fludarabine/Cyclophosphamide: 32.8 months, 95% CI: (29.6, 36.0); Fludarabine/Cyclophosphamide/ Rituximab: 51.8 months, 95% CI: (46.2, 57.6); P<0.0001
NCT00404079	Roland Morris Disability Questionnaire, 1 year		ClinicalTrials.gov score was higher for both trial arms than in publication and statistical testing results were different in two sources.
NCT00404079	Glucosamine Sulphate: 9, SD: 4; Placebo: 9, SD: 4; Odds Ratio: 4.5 ± 4; P=0.05	Glucosamine Sulphate: 4.8, 95% CI: (3.9, 5.6); Placebo: 5.5, 95% CI: (4.7, 6.4); P=0.50
NCT00426751	Number of Participants With Complete Sum ST Resolution 60 Min After Percutaneous Coronary Intervention (Intent-to-Treat Population)		Confidence interval of the adjusted difference between arms crossed zero on ClinicalTrials.gov and did not in publication, suggesting a difference in statistical testing of results between the two sources.
NCT00426751	Eptifibatide: 124/214; Abciximab: 103/196; Adjusted Difference: 6.8%, 95% CI: (−3.0%, 16.6%)	Eptifibatide: 62.6%; Abciximab: 56.3%; Adjusted Difference: 7.1%, 95% CI: (2.7%, 17.0%)

Note: NCT is term used by ClinicalTrials.gov when assigning a unique clinical trial identifier; CI=Confidence Interval