Table 2.
Cases without any information on death numbers in ClinicalTrials.gov record but reports of number of deaths in the corresponding publication
| Population | Was death a specified outcome* Define | Reporting module or location | ClinicalTrials.gov record |
Publication |
||||
|---|---|---|---|---|---|---|---|---|
| Deaths/Randomised |
Deaths/Randomised |
|||||||
| Arm 1 | Arm 2 | Arm 1 | Arm 2 | |||||
| Case 6 | ||||||||
| Influenza vaccine in elderly | No | Follow up: 6 mo | Follow up: 6 mo | |||||
| Flow | -/857 | -/848 | -/870 | -/1262 | -/2575 | -/1262 | ||
| Outcome | – | – | – | – | – | – | ||
| SAE | -/855 | -/848 | -/870 | -/1260 | 16/2573 | 7/1260 | ||
| Total | -/2575 | -/1262 | 16/2575 | 7/1262 | ||||
| Summary | The 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 sclerosis | No | Follow up: 9 mo | Follow up: 10 mo | |||||
| Flow | -/75 | -/75 | 3/75 | 5/75 | ||||
| Outcome | -/75 | -/75 | – | – | ||||
| SAE | -/75 | -/75 | 3/75 | 5/75 | ||||
| Total | -/75 | -/75 | 3/75 | 5/75 | ||||
| Summary | The 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 2 | No | Follow up: 26 wk | Follow up: 26 wk | |||||
| Flow | -/239 | -/241 | -/239 | -/241 | ||||
| Outcome | – | – | – | – | ||||
| SAE | -/231 | -/238 | 0/231 | 1/238 | ||||
| Total | -/239 | -/241 | 0/239 | 1/241 | ||||
| Summary | The 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 cancer | No (in record); Y (in publication) Overall survival was a reported outcome, unclear whether primary or secondary | Follow 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 | -/30 | 20/30 | ||||||
| SAE | -/30 | – | ||||||
| Total | -/30 | 20/30 | ||||||
| Summary | The 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.