Table 2

Cases without any information on death numbers in ClinicalTrials.gov record but reports of number of deaths in the corresponding publication

PopulationWas death a specified outcome* DefineReporting module or locationClinicalTrials.gov recordPublication
Deaths/RandomisedDeaths/Randomised
Arm 1Arm 2Arm 1Arm 2
Case 6
Influenza vaccine in elderlyNoFollow up: 6 moFollow up: 6 mo
Flow-/857-/848-/870-/1262-/2575-/1262
Outcome
SAE-/855-/848-/870-/126016/25737/1260
Total-/2575-/126216/25757/1262
SummaryThe CT.gov record [NCT00391053] did not report deaths counts across 4 arms. The publication [PMID19508159] described 23 deaths under SAE for 2 arms, collapsing arms 1-3 into one.
Case 7
Amyotrophic lateral sclerosisNoFollow up: 9 moFollow up: 10 mo
Flow-/75-/753/755/75
Outcome-/75-/75
SAE-/75-/753/755/75
Total-/75-/753/755/75
SummaryThe CT.gov record [NCT00243932] did not report death counts. The publication [PMID19743457] describes 8 deaths under participant flow as well as under SAE, which are presumably the same.
Case 8
Diabetes Mellitus Type 2NoFollow up: 26 wkFollow up: 26 wk
Flow-/239-/241-/239-/241
Outcome
SAE-/231-/2380/2311/238
Total-/239-/2410/2391/241
SummaryThe CT.gov record [NCT00469092] did not report death counts. The publication [PMID19821654] describes one death under SAE as a ‘treatment emergent death’. It also reported 2 deaths during the run-in period that were not included in the participant flow.
Case 9
Metastatic penile cancerNo (in record); Y (in publication) Overall survival was a reported outcome, unclear whether primary or secondaryFollow up: ‘Timeframe 9 y and 6 mo’Follow up: Duration of enrollment 4/2000 through 9/2008 (max FU up to 7 y 5 mo)
Flow-/30-/30
Outcome-/3020/30
SAE-/30
Total-/3020/30
SummaryThe CT.gov record [NCT00512096] did not include death counts even though “overall survival” was a pre-specified outcome. The publication [PMID20625118] reported 20 deaths for this outcome.
  • *In the ClinicalTrials.gov.record.

  • Data collection in ClinicalTrials.gov on Feb 14 2012.

  • CT.gov, ClinicalTrials.gov; D/C, discontinuation; FU, follow up; NCT, National Clinical Trial (number); SAE, serious adverse events; – (dash), not reported.