Table 6.
Misreported deaths codes in PLATO.
| Country/PLATO ID# | Arm | Death cause (site) | Death cause (NDA) | Audited cause of death |
| Canada | ||||
| 16xxxxxx | Clopidogrel | 12-09 | 11-10 | Failure to thrive (not eating, drinking) in nursing home |
| 16xxxxxx | Clopidogrel | 12-03 | 11-05 | Lung cancer, never on drug |
| 16xxxxxx | Ticagrelor | 11-01 | 12-01 | Cardio-respiratory arrest, sudden death |
| Norway | ||||
| 34xxxxxxx | Ticagrelor | 11-01 | 11-02 | Sudden death |
| 34xxxxxxx | Clopidogrel | 11-10 | 11-11 | Heart failure, but no drug discontinuation as reported |
| Mexico | ||||
| 32xxxxxxx | Clopidogrel | 12-01 | 11-02 | Respiratory failure, intubation, ventilator, definite pulmonary death |
| 32xxxxxxx | Ticagrelor | 11-01 | 11-10 | Sudden death, no heart failure |
| Hungary | ||||
| 26xxxxxxx | Clopidogrel | 12-01 | 11-07 | Respiratory failure, cancer death |
| 26xxxxxxx | Ticagrelor | 11-05 | 97 | Stroke |
| 26xxxxxxx | Clopidogrel | 12-07 | 11-10 | Renal failure |
| 26xxxxxx | Ticagrelor | 11-01 | 11-10 | Sudden death, tamponade, autopsy confirmed |
| 26xxxxxx | Clopidogrel | 11-02 | 11-01 | Myocardial infarction (MI) after possible stent thrombosis |
| 26xxxxxx | Clopidogrel | 12-01 | 12-99 | Hypotension, neurological damage due to hypoxia |
| 26xxxxx | Clopidogrel | 12-01 | 11-01 | Respiratory failure |
| 26xxxxx | Ticagrelor | 11-01 | 11-02 | Sudden death |
| 26xxxxx | Clopidogrel | 12-09 | 11-10 | Multiorgan failure (MOF) |
| 26xxxxx | Clopidogrel | 11-02 | 11-01 | MI |
| Poland | ||||
| 36xxxxx | Ticagrelor | 11-03 | 11-99 | Unstable angina, not unclear or “other” |
| South Korea | ||||
| 40xxxxxx | Clopidogrel | 11-02 | 11-01 | Documented MI, no sudden death |
For the cause of death main codes: “11” – vascular; “12” – non vascular; “97” – unknown; Vascular subcodes: “1” = sudden death; “2” = myocardial infarction; “3” = unstable angina; “4” = other coronary artery disease; “5” = stroke; “6” = arterial embolism; “7” = pulmonary embolism; “8” = ruptured aortic aneurysm; “9” = aortic dissection; “10” = heart failure; “11” = cardiac arrhythmia; “12” = death from bleeding (not trauma); “13” = endocarditis; “14” = valvular disease; “99” = other. Non-vascular codes: “1” = respiratory failure; “2” = pneumonia; “3” = cancer; “4” = trauma; “5” = suicide; “6” = liver failure; “7” = renal failure; “8” = sepsis; “9” = multiorgan failure; “99” = other.