1 Supplemental Table 1: Primary Outcome Result Reporting Discrepancies Between Clinicaltrials.Gov (CT.Gov) and Publication

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Supplemental Table 1: Primary outcome result reporting discrepancies between ClinicalTrials.gov (CT.gov) and publication.

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

Inconsistent Values Reported Between Sources NCT00095238 Irbesartan in Heart Industry 2 4128 Percentage of Irbesartan (n=2067): 39.2% Irbesartan (n=2067): 35.9% 270% larger reduction in risk Failure With Preserved patients with Placebo (n=2061): 39.5% Placebo(n=2061): 37.0% for primary outcome. Systolic Function (I- composite death or After 5 years After 5 years (inferred from Kaplan- Statistical analysis not reported Preserve) cardiovascular Meier figure) in CT.gov hospitalization Difference: -0.3% Difference: -1.1% (p=NR) (p=0.35)

NCT00833794 A Two-Arm Study Industry 2 646 Pain intensity score Tramadol (n=431): 4.3 Tramadol (n=431): 4.2 40% larger treatment effect Comparing the as measured by the Placebo (n=214): 4.8 Placebo (n=214): 4.9 reported in publication. Analgesic Efficacy 11-point Pain Statistical analysis not reported and Safety of Intensity-Numerical Difference: 0.5 Difference: 0.7 in CT.gov Tramadol HCl Once-a- Rating Scale Score (p=NR) (p<0.0001) Day Versus Placebo at week 12 for the Treatment of Pain Due to Osteoarthritis

NCT00879697 Strength Training in Other 2 34 Total walking Strength training (n=15): 618 meters Strength training (n=15): 775 meters 17% larger treatment effect Walking Tolerance in distance at 12 Walking training (n=15): 572 meters Walking training (n=15): 721 meters reported in publication. Intermittent weeks Claudication Patients Difference: 46 meters Difference: 54 meters Probable transcription error as (p<0.05) (p<0.01) CT.gov entry reports baseline values as end of treatment distance

Both sources report statistically significant improvement in walking distance NCT00462748 A Study to Determine Industry 3 786 Percentage of Ezetimibe/simvastatin (n=255): 67.4% Ezetimibe/simvastatin (n=255): 69.4% 15% larger treatment effect the Number of Patients patients achieving a reported in publication versus Who Reach Optimal target of fasting 1) Atorvastatin (n=259): 36.3% 1) Atorvastatin (n=259): 33.5% atorvastatin Cholesterol Levels on LDL-C of 2) Rosuvastatin (n=258): 17.4% 2) Rosuvastatin (n=258): 14.3% Each of Three <2mmol/l at 6 Different Treatments weeks 1) difference: 31.1% (p<0.001) 1) difference: 35.9% (p<0.001) 10% larger treatment effect 2) difference: 50% (p<0.001) 2) difference: 55.1% (p<0.001) reported in publication versus rosuvastatin

Statistical significance unchanged

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

NCT00294515 IMPACT Study: A Industry 2 320 Percentage of 100 days (n=163): 43.6% 100 days (n=163): 36.8% 4% larger effect size, and lower Study of Valcyte patients developing 200 days (n=155): 23.9% 200 days (n=155): 16.1% overall risk of CMV reported in (Valganciclovir) for CMV at end of publication Prevention of treatment (100 days Difference: 20% Difference: 20.7% Cytomegalovirus versus 200 days) (p<0.0002) (p<0.0001) Statistical significance Disease (CMV) in unchanged Kidney Allograft Recipients NCT00406783 Study for the Industry 2 547 Change from Desloratatine (n=271): -3.01 Desloratatine (n=271): -3.19 2% larger treatment effect Treatment of baseline in Total 5 Placebo (n=265): -2.13 Placebo (n=265): -2.29 reported in publication Intermittent Allergic Symptom Score at Rhinitis With day 15 Difference: -0.88 Difference: -0.90 Statistical significance Desloratadine (Study (p<0.001) (p<0.001) unchanged P04683AM1) NCT00257660 Randomized, Placebo- Industry 2 116 Mean change Botulinum IM (n=51): -14.0 Botulinum IM (n=51): -15.6 1% larger treatment effect Controlled Study of Toronto Western Placebo (n=58): -5.2 Placebo (n=58): -6.7 reported in publication AbobotulinumtoxinA Spasmodic (DysportÂ®) for the Torticollis Rating Difference: -8.8 Difference: -8.9% Statistical significance Treatment of Cervical Scale from baseline (p<0.0001) (p<0.0001) unchanged Dystonia to week 4

NCT00104247 Study to Evaluate the Industry 2 88 Change in blood Saproterin (n=41): -239 Saproterin (n=41): -235.9 3% larger treatment effect in Safety and Efficacy of phenylalanine from Placebo (n=46): 6 Placebo (n=47): 2.9 CT.gov Phenoptin, in Subjects baseline to week 6 Difference: -245 Difference: -239 With Phenylketonuria (p<0.001) (p=0.0002) Statistical significance Who Have Elevated unchanged Phenylalanine Levels

NCT00552669 Study of Oral Government 2 200 Overall costs Oral rapamycin (n=100): $5483 Oral rapamycin (n=100): $5586 1% larger treatment effect in Rapamycin Plus Bare expressed in US Drug eluting stent (n=100): $7658 Drug eluting stent (n=100): $7738 CT.gov Metal Stents vs Drug dollars at 18 months Eltuting Stents of follow up Difference: $2175 Difference: $2152 Statistical significance (p<0.05) (p=0.0001) unchanged

Differences in treatment effect unclear or no impact on results NCT00287053 Effects of Divalproex Other 2 57 Change in food Divalproex (n=26): -90 kcal Divalproex (n=26): -51 kcal Purpose of study to determine Sodium on Food intake from baseline Placebo (n=26): -51 kcal Placebo (n=26): -90 kcal mechanism for divalproex Intake, Energy to day 21 associated weight gain Expenditure, and Difference: -39 kcal Difference: 39 kcal Posture Allocation Outcome results transposed between sources

NCT00029172 Treatment for Post- Other 2 188 Percentage of Results not broken down by treatment Case management (n=89): 51% CT.gov reporting not consistent Stroke Depression patients with group (case management vs. usual Control (n=93): 30% with specified outcome (% of HAMD-D response care). Reported only mean HAM-D patients with HAM-D decrease (decrease by 50%) score at week 12: 10.6 of 50% or more) at week 12

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

NCT00494013 Comparison of Two Industry 2 429 Change from Insulin Lispro (n=219): -1.52 Insulin Lispro (n=219): -1.47 Overall least squares mean Basal Insulins for baseline in HbA1c Insulin Detemir (n=210): -1.31 Insulin Detemir (n=210): -1.24 difference consistent Patients With Type 2 at week 24 Diabetes (IOOY) Least squares mean difference: -0.21 Least squares mean difference: -0.21

NCT00422734 Tadalafil Taken Daily Industry 2 342 Three primary Compared to Placebo outcomes on Improvement of Getting and 1) Change from Tadalafil (n=244): 8.0 Tadalafil (n=244): 7.9 Larger treatment effect reported Maintaining an baseline in Placebo (n=72): 0.5 Placebo (n=72): 0.7 in CT.gov Erection and Sexual International Index Difference: 7.5 Difference: 7.2 Quality of Life of Erectile Function P<0.001 P<0.001 - Erectile Function Domain at week 12

2) Change from Q2 Q2 Larger treatment effect reported baseline in Tadalafil (n=251): 28.8% Tadalafil (n=251): 28.6% in CT.gov percentage Placebo (n=74): 2.2% Placebo (n=74): 2.7% responding yes to Difference: 26.6% Difference: 25.9% sexual encounter P<0.001 P<0.001 profile diary question 2 and 3 at Q3 Q3 week 12 Tadalafil (n=251): 46.5% Tadalafil (n=251): 46.0% Placebo (n=74): 10.8% Placebo (n=74): 10.8% Difference: 35.7% Difference: 35.2% P<0.001 P<0.001

3) Change from Subject Subject Larger treatment effect reported baseline in sexual Tadalafil (n=244): 39.4 Tadalafil (n=244): 39.5 in publication QOL domain of Placebo (n=72): 12.6 Placebo (n=72): 12.5 Sexual Life Quality Difference: 26.8 Difference: 27 Questionnaire of P<0.001 P<0.001 subject and partner at week 12 Partner Partner Tadalafil (n=238): 32.9 Tadalafil (n=238): 32.4 Placebo (n=70): 7.9 Placebo (n=70): 5.0 Difference: 25 Difference: 27.4 P<0.001 P<0.001

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

NCT00806403 Comparison Between Other 2 205 Two primary Thrombolysis and outcomes Primary Percutaneous Coronary Intervention 1) Number of Fibrinolytic (n=75): 47 Fibrinolytic (n=74): 47 Analysis denominators (PCI) to Treat ST- patients with ST- Invasive (n=74): 51 Invasive (n=75): 51 transposed Segment Elevation segment elevation Myocardial Infarction resolution equal or more than 50% 120 minutes after inclusion

2) Number of consistent patients with Fibrinolytic (n=65): 35 Fibrinolytic (n=65): 35 thrombolysis in Invasive (n=79): 56 Invasive (n=79): 56 myocardial infarction (TIMI) flow grade 3 5-7 days after inclusion

NCT00852917 A Four-Arm Study Industry 4 552 Three primary Comparing the outcomes Analgesic Efficacy and Safety of 1) Patients' global Tramadol 100mg (n=103): 66% Tramadol 100mg (n=103): 66% Larger treatment effect reported Tramadol Once a Day rating of pain relief Tramadol 200mg (n=107): 75% Tramadol 200mg (n=107): 71% for two arms in CT.gov 100, 200 and 300 mg (% of patient who Tramadol 300mg (n=105): 80% Tramadol 300mg (n=105): 78% Versus Placebo for the report as effective Placebo (n=224): 58% Placebo (n=224): NR Treatment of Pain Due or very effective) at to Osteoarthritis of the week 12 Knee (With 7-Day Follow-up) 2) Percentage Tramadol 100mg (n=103): 41.6% Tramadol 100mg (n=103): 41.6% Consistent reduction from Tramadol 200mg (n=107): 42.8% Tramadol 200mg (n=107): 42.8% baseline in Tramadol 300mg (n=105): 46% Tramadol 300mg (n=105): 46% WOMAC index Placebo (n=224): 32.3% Placebo (n=224): 32.3% pain subscale at week 12

3) Percentage Tramadol 100mg (n=103): 42.3% Tramadol 100mg (n=103): 48% Larger treatment effect for all reduction from Tramadol 200mg (n=107): 42% Tramadol 200mg (n=107): 45% active arms reported in baseline in Tramadol 300mg (n=105): 38.7% Tramadol 300mg (n=105): 46% publication WOMAC index Placebo (n=224): 30.9% Placebo (n=224): 27% physical function subscale at week 12

NCT00337727 Aprepitant for the Industry 2 848 Percentage of Aprepitant (n=425): 324 (76.2%) Aprepitant (n=425): 325 (76.2%) Analysis denominator Prevention of patients reporting Placebo (n=406): 252 (62.1%) Placebo (n=407): 252 (62.1%) discrepancy with no impact on Chemotherapy no vomiting 0 to reported outcome Induced Nausea and 120 hours following Vomiting (CINV) initiation of chemotherapy

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

NCT00452426 Safety and Industry 2 1000 AUC of oxygen CAPS system (n=491): 23.6 CAPS system (n=489): 23.6 Analysis denominator Effectiveness of a desaturation - the Control (n=486): 88.0 Control (n=493): 88.0 discrepancy with no impact on Computer-Assisted difference between reported outcome Personalized Sedation the threshold and (CAPS) Device for actual o2 saturation Propofol Delivery summed every During Endoscopy second during which o2 sat was below threshold NCT00313820 Efficacy Of Pregabalin Industry 2 219 Mean pain score of Pregabalin (n=108): 4.8 Pregabalin (n=110): 4.9 Analysis denominator In Subjects With Post- last 7 measurements Placebo (n=108): 5 Placebo (n=109): 5 discrepancy with no impact on Stroke Central of daily pain rating p=0.578 p=0.578 reported outcome Neuropathic Pain scale at week 12 difference: -0.2 difference: -0.2

NCT00432237 Safety and Efficacy Industry 4 1264 Five primary Only % reported Study of MK0974 outcomes (telcagepant (T)) in the 1) Number of T 50mg (n=176): 29 (16.5%) T 50mg (n=177): 16.5% Analysis denominator Acute Migraine patients reporting T 150mg (n=380): 88 (23.2%) T 150mg (n=381):23.2% discrepancy with no impact on pain freedom at 2 T 300mg (n=369): 88 (23.8%) T 300mg (n=371): 23.8% reported outcomes hours post dose Placebo (n=365): 39 (10.7%) Placebo (n=365): 10.7%

2) Number of T 50mg (n=176): 78 (44.3%) T 50mg (n=177): 44.3% Analysis denominator patients reporting T 150mg (n=380): 205 (53.9%) T 150mg (n=381): 53.9% discrepancy with no impact on pain relief at 2 T300 mg (n=369): 205 (55.6%) T300 mg (n=371): 55.6% reported outcomes hours post dose Placebo (n=365): 120 (32.9%) Placebo (n=365): 32.9%

3) Number of T 50mg (n=176): 72 (40.9%) T 50mg (n=177): 40.9% Analysis denominator patients reporting T 150mg (n=380): 176 (46.3%) T 150mg (n=381): 46.3% discrepancy with no impact on Absence of T300 mg (n=369): 179 (48.5%) T300 mg (n=371): 48.5% reported outcomes photophobia at 2 Placebo (n=365): 119 (32.6%) Placebo (n=365): 32.6% hours post dose

4) Number of T 50mg (n=176): 85 (48.3%) T 50mg (n=177): 48.3% Analysis denominator patients reporting T 150mg (n=380): 192 (50.5%) T 150mg (n=381): 50.5% discrepancy with no impact on Absence of T300 mg (n=369): 206 (55.8%) T300 mg (n=371): 55.8% reported outcomes phonophobia at 2 Placebo (n=365): 152 (41.6%) Placebo (n=365): 41.6% hours post dose

5) Number of T 50mg (n=176): 113 (64.2%) T 50mg (n=177): 64.2% Analysis denominator patients reporting T 150mg (n=380): 260 (68.4%) T 150mg (n=381): 68.6% discrepancy with no impact on absence of nausea at T300 mg (n=369): 258 (69.9%) T300 mg (n=371): 69.9% reported outcomes 2 hours post dose Placebo (n=365): 196 (53.7%) Placebo (n=365): 53.7%

NCT Number Trial Name Fundinga Armsa na Primary Outcome ClinicalTrials.gov Publication Summary of discrepancy

NCT01218958 ALK21-003: Study of Industry 3 624 Percentage of heavy Naltrexone 190mg (n=206): 0.83 Naltrexone 190mg (n=210): 0.83 Analysis denominator Medisorb® drinking days Naltrexone 380mg (n=201): 0.75 Naltrexone 380mg (n=205): 0.75 discrepancy with no impact on Naltrexone through week 24 Placebo (n=204) Placebo (n=209) reported outcomes (VIVITROL®) in (reported as hazard Alcohol-Dependent ratio) Adults

NCT00308711 Safety/Efficacy Study Industry 3 1308 Two primary Comparing the outcomes Misoprostol Vaginal Insert (MVI) to 1) Time from drug MVI 100 mcg (n=426): 1596 MVI 100 mcg (n=428): 1596 Analysis denominator Cervidil for Cervical insertion to vaginal MVI 50 mcg (n=440): 2127 MVI 50 mcg (n=443): 2127 discrepancy with no impact on (DVI) Ripening and delivery in minutes DVI 10 mg (n=431): 1650 DVI 10 mg (n=436): 1650 reported outcomes Induction of Labor

2) Percentage of MVI 100 mcg (n=426): 28% MVI 100 mcg (n=428): 28% Analysis denominator participants with a MVI 50 mcg (n=440): 28% MVI 50 mcg (n=443): 28% discrepancy with no impact on cesarean section DVI 10 mg (n=431): 26% DVI 10 mg (n=436): 26% reported outcomes delivery

NCT00886600 A Study to Investigate Industry 4 122 Two primary the Magnitude and outcomes Duration of Response Analysis denominator of MK0954 Compared 1) Mean change Losartan 50 QD ( n=28): -5.2 Losartan 50 QD ( n=29): -5.2 discrepancy with no impact on to Placebo in Patients from baseline in 24 Losartan 100 QD (n=28):-6.4 Losartan 100 QD (n=28):-6.4 reported outcomes With Hypertension hour diastolic blood Losartan 50 BID (n=30): -8.5 Losartan 50 BID (n=30): -8.5 pressure at week 4 Placebo (n=26): - 0.2 Placebo (n=30): - 0.2

2)Mean change Losartan 50 QD ( n=28): -9.2 Losartan 50 QD ( n=29): -9.2 Analysis denominator from baseline in 24 Losartan 100 QD (n=28): -9.9 Losartan 100 QD (n=28): -9.9 discrepancy with no impact on hour systolic blood Losartan 50 BID (n=30): -13.2 Losartan 50 BID (n=30): -13.2 reported outcomes pressure at week 4 Placebo = (n=26): 0 Placebo = (n=30): 0

a: as reported by CT.gov