Supplemental Table 2: Serious adverse event (SAE) reporting discrepancies between ClinicalTrials.gov (CT.gov) and publication. Number needed to harm (NNH) presented for trials where
intervention associated with an increased risk of an SAE. Number needed to treat (NNT) presented for trials where intervention associated with lower risk of an SAE.
NCT Number
Trial Name
Arms
n
Reporting
Source
>0 SAEs reported in CT.gov - different than number reported in publication
NCT00323492 TOTEM: Switch From Other Nucleoside
2
92
CT.gov
Reverse Transcriptase Inhibitors (NRTIs)
to Once Daily Truvada
SAEs
Reported
10
SAE Risk
Risk difference
NNT/NNH
Truvada= 7/47 (14.9%)
Control (baseline antiretroviral)= 3/45 (6.7%)
Difference= 8.2% (NNH = 13)
Favoring control
Publication
4
Summary of
Discrepancy
Truvada= 1/46 (2.2%)
Control=3/45(6.7%)
Intervention appears
more favorable in
publication which
reports a reduced risk of
SAE
Difference= -4.5% (NNT = 23 )
Favoring intervention
Publication notes 3 individuals with SAEs in control (intestinal obstruction, sciatica, pneumonia) and 1 SAE with Truvada (impaired renal function)
NCT00097591
CT.gov reports SAEs in 9 categories. CT.gov notes same 3 SAEs with control and a total of 7 individuals with Truvada (1 intestinal obstruction, 1 prostatic adenoma, 1 nephrolithiasis, 2 renal
failure, 1 renal impairment, 1 tubulointerstitial nephritis, 1 asthma). Cannot distinguish where the same individual experienced >1 SAE.
A Comparison of Prasugrel (CS-747) and
2
13608 CT.gov
3406
Prasugrel= 1731/6741 (25.7%)
Clopidogrel in Acute Coronary Syndrome
Control (clopidogrel)= 1675/6716 (24.9%)
Subjects Who Are to Undergo
Percutaneous Coronary Intervention
Difference= 0.8% (NNH = 125)
Favoring control
Intervention appears
more favorable in
publication which
Publication
3082
Prasugrel= 22.5%
reports a reduced risk of
Control (clopidogrel)= 22.8%
SAE
(counts not reported)
Difference= -0.3% (NNT = 334)
Favoring intervention
Publication only reports non-hemorrhagic SAEs and not broken down into categories
NCT00075218
CT.gov reports SAE in 856 categories.
A Study To Assess The Safety And
Efficacy Of SU11248 In Patients With
Gastrointestinal Stromal Tumor(GIST)
2
361
CT.gov
110
Sunitinib= 83/228 (36.4%)
Control (placebo)=27/114 (23.7%)
Difference= 12.7 % (treatment NNH=8)
Favoring control
Publication
45*
Sunitinib= 40/202 (19.8%)
Control (placebo)=5/102 (5.0%)
Difference= 14.8 % (treatment NNH=7)
Favoring control
Publication only reports treatment attributable SAEs. Publication does not report specific SAE types.
CT.gov reports SAEs in 222 categories
Intervention appears
less favorable in
publication with 1 fewer
patient treated to cause
one SAE
NCT Number
NCT00603798
Trial Name
Safety and Effectiveness Study of
Imiquimod Creams for the Treatment of
Actinic Keratoses (AKs)
Arms
3
n
490
Reporting
Source
CT.gov
Publication
SAEs
Reported
18
13
SAE Risk
Risk difference
NNT/NNH
‡Imiquimod 3.75%=10/162 (6.2%)
Imiquimod 2.5%=5/164 (3.1%)
Control (Placebo)= 3/164 (1.8%)
Difference= 4.4% (intervention NNH=23)
Favoring control
‡Imiquimod 3.75%=7/162 (4.3%)
Imiquimod 2.5%=4/164 (2.4%)
Control (Placebo)= 2/164 (1.2%)
Summary of
Discrepancy
Intervention appears
more favorable in
publication with 10
additional patients
needed to be treated to
cause one SAE
‡Difference= 3.1% (intervention NNH=33)
Favoring control
Publication does not report specific SAE types. Reports “one serious AE, pancytopenia in the imiquimod 3.75% group, was considered by the investigator to be probably related to study
cream.”
CT.gov reports SAEs in 17 categories. CT.gov reports 1 participant with pancytopenia.
NCT00092521
Cervical Intraepithelial Neoplasm (CIN)Warts Efficacy Trial in Women (Gardasil)
2
5455
CT.gov
95
Vaccine= 50/2674 (1.9%)
Control (Placebo)= 45/2673 (1.7%)
Difference= 0.2% (NNH = 500)
Favoring control
Publication
93
Vaccine= 48/2673 (1.8%)
Control (Placebo)= 45/2672 (1.7%)
Intervention appears
more favorable in
publication with 500
more patients needed to
be treated to cause one
SAE
Difference= 0.1% (NNH = 1000)
Favoring control
Publication reports the following SAEs by 12 organ system categories (e.g . infections and infestations)
CT.gov reports SAEs in 60 categories by specific event (e.g. appendicitis) and not number of individuals in each organ system category.
NCT00087516
Monotherapy Study in Patients With Type
2 Diabetes Mellitus
3
741
CT.gov
Publication
72
33
‡Sitagliptin 100mg= 24/238 (10.1%)
Sitagliptin 200mg =25/250 (10.0%)
Control (Placebo)= 23/253 (9.1%)
Difference= 1.0% (NNH = 100)
Favoring control
‡Sitagliptin 100mg= 12/238 (5.0%)
Sitagliptain 200mg=12/250 (4.8%)
Control (Placebo)= 9/253 (3.6%)
‡Difference= 1.4% (NNH = 72)
Favoring control
Publication does not report specific SAE types.
CT.gov reports SAEs in 61 categories.
Intervention appears
less favorable in
publication with 28
fewer patients needed to
be treated to cause one
SAE
NCT Number
NCT00462748
Trial Name
A Study to Determine the Number of
Patients Who Reach Optimal Cholesterol
Levels on Each of Three Different
Treatments.
Arms
3
n
786
Reporting
Source
CT.gov
Publication
SAEs
Reported
10
11
SAE Risk
Risk difference
NNT/NNH
Summary of
Discrepancy
Ezetimibe/simvastatin= 4/259 (1.5%)
Atorvastatin= 2/260 (0.8%)
Rosuvastatin=4/261 (1.5%)
Difference= 0.7% vs. atorvastatin (NNH = 143)
Difference= 0 vs. rosuvastatin (NNH = NA)
Favoring control
Ezetimibe/simvastatin= 4/259 (1.5%)
Atorvastatin= 2/260 (0.8%)
Rosuvastatin=5/261 (1.9%)
Intervention appears
more favorable in
publication which
reports a reduced risk of
SAE relative to
rosuvastatin
Difference= 0.7% vs. atorvastatin (NNH = 143)
Difference= -0.4% vs. rosuvastatin (NNT = 250)
Direction mixed
Publication does not report specific SAE types.
CT.gov reports SAEs in 10 categories.
NCT00460564
Study Of GSK1358820 In Patients With
Post-Stroke Upper Limb Spasticity
4
109
CT.gov
Publication
10
6
BTX combined arms= 7/72 (9.7%)
Control (combined high/low dose placebo)= 3/37 (8.1%)
Difference= 1.6% (NNH=63)
Favoring control
BTX combined arms= 5/72 (6.9%)
Control (combined high/low dose placebo)= 1/37 (2.7%)
Intervention appears
less favorable in
publication with 29
fewer patients needed to
cause one SAE
Difference= 4.2% (NNH=24)
Favoring control
Publication reports 1patient in low dose BTX group with chronic bronchitis and 4 patients in high dose BTX group with 7 total cases- pyothorax, pleurisy, humerus fracture, tibia fracture,
epilepsy, facial bones fracture and traumatic intracranial haemorrhage. 1 patient in the control group with blood pressure increase/musculoskeletal stiffness (same patient)
NCT00094458
CT.gov reports 1patient in low dose BTX group with chronic bronchitis. In the high dose BTX group, CT.gov reports 1 acute myocardial infarction, 1 pyothorax, 1 facial bone fracture, 1 tibia
fracture, 1 traumatic intracranial hemorrhage, 1 diabetes mellitus, 1 epilepsy, 1 pleurisy (impossible to discern which patient had more than 1 event)
In control CT.gov reports 1 patient with colonic polyp, 1 patient with nephrolithiasis, and 1 each with blood pressure increase and musculoskeletal stiffness (impossible to discern if same
patient).
Trial Comparing Infliximab and
3
508
CT.gov
90
Infliximab/AZA= 25/179 (14.0%)
Infliximab and Azathioprine in the
Infiximab= 26/163 (16.0%)
Treatment of Patients With Crohn's
AZA= 39/161 (24.2%)
Disease naive to Both Immunomodulators
and Biologic Therapy (Study of Biologic
Difference= -2.0% vs. infliximab (NNT=50)
Intervention appears
and Immunomodulator Naive Patients in
Difference= -10.2% vs AZA (NNT=10)
more favorable in
Chrohn's Disease: SONIC
Favoring intervention
publication with
between 1 and 38 fewer
patients needed to be
Publication
109
Infliximab/ AZA = 27/179 (15.1%)
treated to avoid one
Infliximab=39/163 (23.9%)
SAE
AZA= 43/161 (26.7%)
Difference= -8.8% vs. infliximab (NNT=12)
Difference= -11.6% vs. AZA (NNT=9)
Favoring intervention
Publication does not report specific SAE types.
CT.gov reports SAEs in 77 categories.
NCT Number
Trial Name
NCT00355615
PLUTO: Pediatric Lipid-reduction Trial of
rosuvastatin
Arms
4
n
177
Reporting
Source
CT.gov
SAEs
Reported
3
SAE Risk
Risk difference
NNT/NNH
Combined rosuvastatin doses= 2/130 (1.5%)
Control (Placebo)= 1/46 (2.2%)
Difference= -0.7% (NNT=143)
Favoring intervention
Publication
2
Summary of
Discrepancy
Combined rosuvastatin doses= 1/130 (0.8%)
Control (Placebo)= 1/46 (2.2%)
Intervention appears
more favorable in
publication with 71
fewer patients needed to
avoid one SAE
Difference= -1.4% (NNT=72)
Favoring intervention
Publication reports 1participant with blurred vision SAE in control and 1 participant with vesicular rash SAE in open label phase
CT.gov reports1participant with blurred vision SAE in control, 1 participant with vesicular rash SAE, and 1 patient with appendicitis both in open label phase
NCT00402324
A Comparison of Olanzapine in
Combination With a Mood Stabilizer vs
Mood Stabilizer Alone, in Mixed Bipolar
Patients
2
202
CT.gov
Publication
8
7
Olanzapine/divalproex= 3/101 (3.0%)
Control (divalproex)= 5/101 (5.0%)
Difference= -2.0% (NNT = 50)
Favoring intervention
Olanzapine/divalproex= 2/101 (2.0%)
Control (divalproex)=5/101 (5.0%)
Intervention appears
more favorable in
publication with 16
fewer patients need to
be treated to avoid one
SAE
Difference= -3.0% (NNT = 34)
Favoring intervention
Publication notes 2 olanzapine individuals with an SAE (1 head injury from traffic accident, 1 hepatic failure). 5 patients receiving control experienced an SAE (n=1 for each term:
spontaneous abortion, asthenia, chest pain, hypoesthesia, overdose)
NCT00271817
CT.gov reports SAEs in 11 categories. CT.gov notes 3 olanzapine individuals with an SAE (1 death, 1 hepatic failure, 1 head injury, 1 road traffic accident, 1 bipolar I disorder). 5 control
subjects experienced an SAE (1 asthenia, 1 chest pain 1 skin laceration, 1 hypoesthesia, 1 spontaneous abortion, 1 bipolar I disorder).
Cannot distinguish where the same individual experienced >1 SAE.
To Evaluate Ezetimibe/Simvastatin and
3
1220
CT.gov
37
Ezetimibe/simvastatin + niacin= 16/670 (2.4%)
Niacin (Extended Release Tablet) in
Ezetimibe/simvastatin=13/272 (4.8%)
Patients With Type IIa or Type IIb
Niacin=8/272 (2.9%)
Hyperlipidemia
Intervention appears
Difference= -2.4% vs. ezetimibe/simvastatin (NNT=42)
less favorable in
Difference= -0.5% vs. niacin (NNT=200)
publication with 158
Favoring intervention
additional patients
Publication
28
Ezetimibe/simvastatin + niacin= 14/670 (2.1%)
needed to avoid one
Ezetimibe/simvastatin=7/272 (2.6%)
SAE relative to
Niacin=7/272 (2.6%)
ezetimibe/simvastatin
Difference= -0.5% vs. ezetimibe/simvastatin (NNT=200)
Difference= -0.5% vs. niacin (NNT=200)
Favoring intervention
Publication does not report specific SAE types.
CT.gov reports 6 SAEs in 6 categories.
NCT Number
Trial Name
NCT00095238
Irbesartan in Heart Failure With Preserved
Systolic Function (I-Preserve)
Arms
2
n
4128
Reporting
Source
CT.gov
Publication
SAEs
Reported
2301
269
a
SAE Risk
Risk difference
NNT/NNH
Summary of
Discrepancy
Irbesartan= 1146/2064 (55.5%)
Control (placebo)= 1155/2062 (56.0%)
Difference= -0.5% (NNT=200)
Favoring intervention
Irbesartan= 141/2067 (6.8%)
Control (placebo)= 128/2061 (6.2%)
Intervention appears
less favorable in
publication reporting an
increased risk of SAE
Difference= 0.6% (NNH=167)
Favoring control
Publication only reports SAEs due to hypotension (irbesartan=12 vs control=9), renal failure (irbesartan=69 vs control=57), hyperkalemia (irbesartan=60 vs control=62) .
CT.gov reports SAEs in 963 categories. Of the SAEs reported in the publication, CT.gov reports more individuals with hypotension (irbesartan=25 vs control=20), renal failure (irbesartan=32
vs control=30), hyperkalemia (irbesartan=11 vs control=8) than the publication.
NCT00285012
Smoking Cessation in Subjects With Mildto-moderate Chronic Obstructive
Pulmonary Disease (COPD)
2
499
CT.gov
Publication
17
18
Varenicline= 6/248 (2.4%)
Control (placebo)= 11/251 (4.4%)
Difference= -2.0% (NNT = 50)
Favoring intervention
Varenicline= 7/248 (2.8%)
Control (placebo)= 11/251 (4.4%)
Intervention appears
less favorable in
publication with 13
additional patients
needed to be treated to
avoid one SAE
Difference= -1.60% (NNT = 63)
Favoring intervention
Publication does not report specific SAE types
CT.gov reports SAEs in 16 categories
NCT00313313
A Study of Saxagliptin in Subjects With
Type 2 Diabetes Who Have Inadequate
Blood Sugar Control With Sulfonylureas
3
768
CT.gov
53
Saxagliptin 2.5 mg/5 mg combined= 30/501 (6.0%)
Control (glyburide)= 23/267 (8.6%)
Difference= -2.6% (NNT = 39)
Favoring intervention
Publication
16
Saxagliptin 2.5 mg/5 mg combined= 10/501 (2.0%)
Control (glyburide)= 6/267 (2.2%)
Intervention appears
less favorable in
publication with 461
additional patients
needed to be treated to
avoid one SAE
Difference= -0.2% (NNT = 500)
Favoring intervention
NCT00393718
Publication mentions that “no hypoglycaemic event was judged by the study investigator to be an SAE.” No other details of SAE types are reported.
CT.gov reports 2 participants with SAE of hypoglycaemia (one in each saxaglipitin arm). CT.gov reports 44 SAE categories.
Effect of Liraglutide on Blood Glucose
2
400
CT.gov
34
Liraglutide= 20/268 (7.5%)
Control in Subjects With Type 2 Diabetes
Control (glyburide)= 14/132 (10.6%)
Difference= -3.1% (NNT=33)
Favoring intervention
Publication
21
Liraglutide= 13/268 (4.9%)
Control (glyburide)= 8/132 (6.1%)
Difference= -1.2% (NNT=84)
Favoring intervention
Publication does not report specific SAE types
CT.gov reports SAEs in 35 categories
Intervention appears
less favorable in
publication with 51
additional patients
needed to be treated to
avoid one SAE
NCT Number
NCT00727857
Trial Name
Efficacy and Safety of Pioglitazone and
Metformin Combination Therapy in
Treating Type 2 Diabetes Mellitus.
Arms
3
n
600
Reporting
Source
CT.gov
Publication
SAEs
Reported
10
8
SAE Risk
Risk difference
NNT/NNH
Summary of
Discrepancy
Pioglitazone/metformin=2/201 (1.0%)
Pioglitazone= 3/190 (1.6%)
Metformin= 5/209 (2.4%)
Difference= -0.6% vs. pioglitzone (NNT=167)
Difference=-1.4% vs. metformin (NNT=72)
Favoring intervention
Pioglitazone/metformin=2/201 (1.0%)
Pioglitazone=3/190 (1.6%)
Metformin= 3/209 (1.4%)
Intervention appears
less favorable in
publication with 178
additional patients
needed to be treated to
avoid one SAE relative
to metformin
Difference= -0.6% vs. pioglitazone (NNT=167)
Difference = -0.4% vs. metformin (NNT=250)
Favoring intervention
Publication does not report specific SAE types
CT.gov reports SAEs in 10 categories.
NCT00102440
Febuxostat Versus Allopurinol Control
Trial in Subjects With Gout
3
760
CT.gov
47
‡Febuxostat 80mg= 10/256 (3.9%)
Febuxostat 120mg =19/251 (7.6%)
Control (Allopurinol)= 18/253 (7.1%)
Difference= -3.2% (NNT=32)
Favoring intervention
Publication
51
‡Febuxostat 80mg= 11/256 (4.2%)
Feuxostat 120mg=21/25 (8.4%)
Control (Allopurinol)= 19/253 (7.5%)
Similar SAE risks
reported
‡Difference= -3.2% (NNT=32)
Favoring intervention
Publication does not report specific SAE types.
CT.gov reports SAEs 46 categories.
NCT00494013
Comparison of Two Basal Insulins for
Patients With Type 2 Diabetes (IOOY)
2
429
CT.gov
8
Lispro=7/219 (3.2%)
Control (Insulin detemir)=1/210 (0.5%)
Difference= 2.7%(NNH=38)
Favoring control
Publication
2
Not broken out by group
Text only mentions “two of seven patient-reported severe hypoglycaemia episodes as serious AE” and does not attribute to a group
CT.gov reports SAEs in 9 categories. 2 patients reporting SAE of hypoglycemia in Lispro group, 0 in control group.
Ambiguous, 2 cases of
serious hypoglycemia
described in publication
but not attributed to a
specific group. CT.gov
reports 2 patients
receiving intervention
having SAE of
hypoglycemia
NCT Number
NCT00450437
Trial Name
A Study to Evaluate Safety and Immune
Response of Novartis Meningococcal
ACWY Conjugate Vaccine In US
Adolescents and Adults
Arms
4
n
2180
Reporting
Source
CT.gov
SAEs
Reported
28
SAE Risk
Risk difference
NNT/NNH
Novartis meningococcal vaccine = 23/2649 (0.9%)
Control (Licensed meningococcal vaccine) = 5 / 875 (0.6%)
Difference = 0.3% (NNH=334)
Favoring control
Publication
18
SAEs only reported for age 11-18 subgroup
CT.gov
936
Vytorin= 471/943 (49.9%)
Control (placebo)= 465/929 (50.1%)
Summary of
Discrepancy
SAE risks cannot be
compared because of
non-comparable
subgroup reporting in
publication
Publication does not report specific SAE types.
CT.gov reports SAEs in 33 categories
NCT00092677
An Investigational Drug on Clinical
Outcomes in Patients With Aortic Stenosis
(Narrowing of the Major Blood Vessel of
the Heart)
2
1873
Publication
931
Difference= -0.2% (NNT=500)
Favoring intervention
Vytorin= 468/943 (49.6%)
Control (placebo)=463/929 (49.8%)
Similar SAE risks
reported in both sources
Difference= -0.2% (NNT=500)
Favoring intervention
Publication does not report specific SAE types
CT.gov reports SAEs in 562 categories.
>0 SAEs reported in CT.gov – Count of SAEs not reported in publication
NCT00080301 Novel Epothilone Plus Capecitabine
2
752
Versus Capecitabine Alone in Patients
With Advanced Breast Cancer
CT.gov
278
Ixabepilone/capecitabine= 151/369 (40.9%)
Control (capecitabine)= 127/368 (34.8%)
Difference= 6.4% (NNH = 16)
Favoring control
Publication
NR
CT.gov
13
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 199 categories
NCT00487240
Comparison of Two Basal Insulin
Therapies for Patients With Type 1
Diabetes
2
381
Lispro= 10/192 (5.2%)
Control (Insulin detemir)=3/189 (1.6%)
Difference= 3.6% (NNH = 28)
Favoring control
Publication
CT.gov reports SAEs in15 categories
NR
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
NCT Number
Trial Name
NCT00003869
Carboxyamidotriazole in Treating Patients
With Stage III or Stage IV Non-small Cell
Lung Cancer
Arms
2
n
186
Reporting
Source
CT.gov
SAEs
Reported
15
SAE Risk
Risk difference
NNT/NNH
Carboxyamidotriazole= 9/90 (10%)
Control (placebo)= 6//92 (6.5%)
Difference= 3.5% (NNH = 29)
Favoring control
Publication
NR
CT.gov
357
Summary of
Discrepancy
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 29 categories
NCT00308711
Safety/Efficacy Study Comparing the
Misoprostol Vaginal Insert to Cervidil for
Cervical Ripening and Induction of Labor
3
1308
Combined misoprostol=240/871 (27.6%)
Control (dinoprostone)=117/436 (26.8%)
Difference= 0.8% (NNH = 125)
Favoring control
Publication
NR
CT.gov
516
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 55 categories
NCT00046228
A Study of Abciximab and Reteplase
When Administered Prior to Catherization
After a Myocardial Infarction (Finesse)
3
2452
Comparison against primary PCI primary
hypothesis
Abciximab/reteplase PCI=175/814 (21.5%)
Abciximab PCI= 182/805 (22.6%)
Primary PCI= 159/795 (20.0%)
Difference=1.5% vs. primary PCI Favoring control (NNH =
67)
Publication
NR
CT.gov
494
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 223 categories
NCT00115765
PACCE: Panitumumab Advanced
Colorectal Cancer Evaluation Study
4
1053
subjects randomly assigned to twice, first
to an oxaliplatin or irinotecan based
chemotherapy and then to either
panitumumab/bevacizumab or
bevacizumab alone. SAEs presented
combined arms
Difference=22.2% (NNH = 5)
Favoring control
Publication
CT.gov reports SAEs in 341categories
Panitumumab/bevacizumab =306/518 (59.1%)
Control (bevacizumab) =188/510 (36.9%)
NR
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
NCT Number
Trial Name
NCT00318461
To Compare the Effect of Liraglutide
When Given Together With Metformin
With the Effect of Metformin Given Alone
and With the Effect of Glimepiride and
Metformin Given Together
Arms
5
n
1087
Reporting
Source
CT.gov
SAEs
Reported
110
SAE Risk
Risk difference
NNT/NNH
Liraglutide (0.6mg, 1.2mg, 1.8mg) combined arms= 77/724
(10.6%)
Control (metformin)= 9/121 (7.4%)
Difference=3.2% (NNH = 32)
Favoring control
Publication
NR
CT.gov
5
Summary of
Discrepancy
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 106 categories
NCT00129402
Effects of Ezetimibe With Simvastatin in
the Therapy of Adolescents With HeFH
(Study P02579)(COMPLETED)
6
248
Combined ezetimibe/simvastatin= 4/126 (3.2%)
Control (combined simvastatin)=1/122 (0.8%)
Difference=2.4% (NNH = 42)
Favoring control
Publication
NR
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 9 categories
NCT00300482
Evaluate Safety and Efficacy of ABT-335
in Combination With Rosuvastatin
Calcium in Subjects With Multiple
Abnormal Lipid Levels in the Blood
6
1439
CT.gov
35
Combined fenofibric acid arms= 23/781 (2.9%)
Control (combined rosuvastatin arms)=12/658 (1.8%)
Difference= 1.1% (NNH = 91)
Favoring control
Publication
NR
CT.gov
153
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 34 categories
NCT00225277
Efficacy Study of Pioglitazone Compared
to Glimepiride on Coronary
Atherosclerotic Disease Progression in
Subjects With Type 2 Diabetes Mellitus
2
543
Pioglitzone=76/270 (28.1%)
Control (glimepiride)= 77/273 (28.2%)
Difference= -0.1% (NNT = 1000)
Favoring intervention
Publication
NR
CT.gov
38
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 110 categories
NCT00441545
Head to Head Study Against Sevelamer
Hydrochloride
2
182
Lanthanum=18/170 (10.6%)
Control (sevelamer)= 20/163 (12.3%)
Difference= -1.7% (NNT = 59)
Favoring intervention
Publication
CT.gov reports SAEs in 28 categories
NR
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
NCT Number
Trial Name
NCT00552669
Study of Oral Rapamycin Plus Bare Metal
Stents vs Drug Eltuting Stents
Arms
2
n
200
Reporting
Source
CT.gov
SAEs
Reported
24
SAE Risk
Risk difference
NNT/NNH
Oral sirolimus/stent= 9/100 (9.0%)
Control (Drug eluting stent)= 15/100 (15.0%)
Difference= -6.0% (NNT = 17)
Favoring intervention
Publication
NR
CT.gov
8
Summary of
Discrepancy
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
CT.gov reports SAEs in 4 categories
>0 SAEs reported in CT.gov – reported as 0 in publication
NCT00363142 A Study of an Investigational Regimen
2
Combining FDA Approved HIV Drugs in
HIV-Infected Subjects
209
FPV/RTV100=7/142 (4.9%)
Control (FPV/RTV200)=1/67 (1.5%)
Difference= 3.4% (NNH = 30)
Favoring controL
Publication
0*
CT.gov
1
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
Publication reports no treatment-related SAEs
CT.gov reports SAEs in 9 categories
NCT00360490
Study in Women With Idiopathic
Menorrhagia to Determine the Reduction
in Menstrual Blood Loss (MBL) After
Treatment With the Levonorgestrelreleasing Intrauterine System (IUS)
2
165
Difference= 1.2% (NNH = 84)
Favoring control
Publication
NCT00236938
IUS= 1/82 (1.2%)
Control (medroxyprogesterone)= 0/83 (0%)
0*
Publication reports: “no deaths or drug-related serious adverse event occurred during study period”
CT.gov reports 1 patient with endometriosis
Efficacy and Safety of Venofer (Iron
2
121
CT.gov
14
Venofer= 9/75 (12.0%)
Sucrose Injection USP) in Patients
Control (no treatment)= 5/46 (10.9%)
Receiving Peritoneal Dialysis
Difference=1.1% (NNH = 91)
Favoring control
Publication
0
CT.gov
2
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
Publication reports: “There were no serious adverse drug events”
CT.gov reports SAEs in 14 categories
NCT00975507
ProQuad Versus MMR II and VARIVAX
in Healthy Children
2
480
Quadrivalent MMR=1/321 (0.3%)
Control (MMR + varicella vaccine)= 1/156 (0.6%)
Difference= -0.3% (NNT=334)
Favoring intervention
Publication
Publication reports: “no vaccine-related serious adverse events were reported”
CT.gov reports SAEs in 4 categories
0*
Intervention appears
more favorable in
publication because
SAEs not reported in
publication
NCT Number
Trial Name
Zero SAEs reported in CT.gov
NCT00029172 Treatment for Post-Stroke Depression
Arms
2
n
188
Reporting
Source
CT.gov
Publication
SAEs
Reported
0
17
SAE Risk
Risk difference
NNT/NNH
Summary of
Discrepancy
0
Not specified by group
“In total, 22 serious adverse events were reported in 17 subjects, but overall event rates were not significantly different between groups”
*=Publication only reports treatment attributable SAEs; ‡FDA approved dose; a Maximum possible SAEs implied by publication is 269;
NR=SAEs not reported; NA=not applicable; AZA= Azathioprine; BTX= botulinum toxin type A; FPV/RTV=fosamprenavir/ritonavir;
Unclear because
publication does not
report by group