Table 4.
Summary of self-controlled case series results for HCQ
|
CCAE |
Clinformatics |
CPRD |
JMDC Claims Database |
MDCD |
MDCR |
VA |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | Calibrated incidence rate ratio | Calibrated 95% CI | |
| Myocardial infarction | ||||||||||||||
| Adjusted analysis* | 0·91 | 0·69–1·21 | 1·11 | 0·81–1·54 | NA | NA | NA | NA | NA | NA | 1·09 | 0·86–1·39 | 0·99 | 0·73–1·34 |
| Primary analysis | 0·92 | 0·70–1·22 | 1·02 | 0·74–1·40 | NA | NA | NA | NA | 0·89 | 0·70–1·15 | 0·99 | 0·78–1·26 | 1·00 | 0·74–1·36 |
| Acute pancreatitis events | ||||||||||||||
| Adjusted analysis* | NA | NA | 1·05 | 0·75–1·46 | NA | NA | 2·18 | 0·11–43·82 | 1·13 | 0·86–1·47 | 1·03 | 0·77–1·36 | 0·97 | 0·71–1·34 |
| Primary analysis | 0·90 | 0·68–1·20 | 1·05 | 0·75–1·46 | NA | NA | 2·11 | 0·14–31·50 | 1·12 | 0·86–1·46 | 0·99 | 0·74–1·32 | 0·98 | 0·71–1·35 |
| Acute renal failure | ||||||||||||||
| Adjusted analysis* | 0·88 | 0·67–1·16 | 0·96 | 0·58–1·59 | NA | NA | 1·33 | 0·31–5·71 | NA | NA | 1·08 | 0·85–1·37 | NA | NA |
| Primary analysis | 0·90 | 0·69–1·19 | 0·99 | 0·72–1·37 | NA | NA | 1·39 | 0·32–6·12 | 1 | 0·80–1·25 | 0·97 | 0·76–1·23 | 1·11 | 0·83–1·50 |
| Gastrointestinal bleeding | ||||||||||||||
| Adjusted analysis* | NA | NA | 1·13 | 0·82–1·55 | NA | NA | 0·25 | 0·03–2·44 | 0·95 | 0·75–1·20 | 1·02 | 0·81–1·30 | NA | NA |
| Primary analysis | 1·01 | 0·76–1·32 | 1·06 | 0·77–1·46 | NA | NA | 0·24 | 0·03–2·38 | 0·95 | 0·76–1·20 | 0·96 | 0·76–1·22 | 0·97 | 0·72–1·32 |
| Cardiac arrhythmia | ||||||||||||||
| Adjusted analysis* | 0·95 | 0·72–1·25 | 1·03 | 0·74–1·42 | 0·95 | 0·61–1·47 | 0·62 | 0·18–2·15 | 0·93 | 0·74–1·17 | 0·85 | 0·67–1·09 | 0·86 | 0·64–1·17 |
| Primary analysis | 0·95 | 0·72–1·26 | 1·03 | 0·74–1·43 | 0·95 | 0·61–1·48 | 0·58 | 0·17–1·98 | 0·93 | 0·74–1·17 | 0·86 | 0·67–1·10 | 0·85 | 0·63–1·15 |
| Bradycardia | ||||||||||||||
| Adjusted analysis* | NA | NA | 0·91 | 0·65–1·27 | 0·65 | 0·20–2·16 | 3·67 | 0·26–50·91 | NA | NA | 0·87 | 0·68–1·12 | 0·88 | 0·65–1·20 |
| Primary analysis | 0·72 | 0·54–0·96 | 0·92 | 0·67–1·28 | 0·68 | 0·21–2·18 | 3·69 | 0·26–51·54 | 0·74 | 0·55–0·99 | 0·87 | 0·68–1·12 | 0·93 | 0·68–1·26 |
| Chest pain or angina | ||||||||||||||
| Adjusted analysis* | 0·91 | 0·69–1·21 | 1·07 | 0·77–1·48 | 0·98 | 0·63–1·52 | 0·92 | 0·45–1·85 | 1·07 | 0·84–1·38 | 0·95 | 0·75–1·21 | NA | NA |
| Primary analysis | 0·91 | 0·69–1·21 | 1·06 | 0·76–1·47 | 0·98 | 0·63–1·52 | 0·91 | 0·45–1·84 | 1·07 | 0·84–1·36 | 0·94 | 0·74–1·20 | 0·98 | 0·73–1·33 |
| End-stage renal disease | ||||||||||||||
| Adjusted analysis* | 1·02 | 0·69–1·51 | NA | NA | 0·91 | 0·15–5·49 | NA | NA | NA | NA | 0·88 | 0·66–1·18 | 1·04 | 0·76–1·44 |
| Primary analysis | 1·03 | 0·76–1·39 | 1·26 | 0·90–1·76 | 0·91 | 0·15–5·31 | NA | NA | 1·24 | 0·93–1·64 | 0·88 | 0·66–1·19 | 1·02 | 0·74–1·40 |
| Heart failure | ||||||||||||||
| Adjusted analysis* | 0·99 | 0·75–1·29 | 1·15 | 0·83–1·58 | 1·20 | 0·69–2·09 | 1·02 | 0·50–2·10 | 0·95 | 0·75–1·20 | 1·12 | 0·88–1·42 | 1·03 | 0·76–1·39 |
| Primary analysis | 0·99 | 0·75–1·30 | 1·13 | 0·82–1·56 | 1·21 | 0·69–2·11 | 1·02 | 0·49–2·08 | 0·95 | 0·75–1·20 | 1·09 | 0·86–1·39 | 1·04 | 0·77–1·40 |
| Hepatic failure | ||||||||||||||
| Adjusted analysis* | 0·68 | 0·50–0·92 | NA | NA | NA | NA | 1·54 | 0·08–30·15 | 0·83 | 0·60–1·16 | 0·82 | 0·58–1·17 | NA | NA |
| Primary analysis | 0·64 | 0·47–0·88 | 0·73 | 0·52–1·02 | 0·09 | 0·01–1·35 | 1·48 | 0·07–33·23 | 0·77 | 0·55–1·07 | 0·81 | 0·57–1·15 | 0·79 | 0·56–1·11 |
| Stroke | ||||||||||||||
| Adjusted analysis* | NA | NA | 0·97 | 0·70–1·34 | NA | NA | 1·13 | 0·36–3·55 | 0·90 | 0·71–1·14 | 1·01 | 0·80–1·29 | 0·96 | 0·71–1·31 |
| Primary analysis | 0·80 | 0·61–1·06 | 0·90 | 0·65–1·24 | NA | NA | 1·14 | 0·36–3·59 | 0·85 | 0·67–1·08 | 0·93 | 0·73–1·18 | 0·98 | 0·72–1·34 |
| Cardiovascular events | ||||||||||||||
| Adjusted analysis* | NA | NA | 0·90 | 0·37–2·21 | NA | NA | 0·51 | 0·21–1·25 | 0·91 | 0·73–1·15 | 1·10 | 0·87–1·40 | NA | NA |
| Primary analysis | 0·86 | 0·66–1·14 | 0·95 | 0·69–1·31 | NA | NA | 0·50 | 0·20–1·25 | 0·86 | 0·68–1·08 | 1·02 | 0·80–1·29 | 1·08 | 0·80–1·46 |
| Transient ischaemic attack | ||||||||||||||
| Adjusted analysis* | 0·91 | 0·69–1·20 | 0·94 | 0·68–1·30 | NA | NA | NA | NA | 0·94 | 0·72–1·23 | 1 | 0·79–1·28 | NA | NA |
| Primary analysis | 0·92 | 0·70–1·21 | 0·93 | 0·68–1·29 | NA | NA | NA | NA | 0·92 | 0·71–1·20 | 0·97 | 0·76–1·24 | 1·20 | 0·88–1·65 |
| Venous thromboembolism | ||||||||||||||
| Adjusted analysis* | 0·79 | 0·54–1·15 | 0·86 | 0·62–1·18 | 0·70 | 0·45–1·09 | 1·51 | 0·62–3·67 | 0·88 | 0·71–1·10 | 0·76 | 0·60–0·96 | NA | NA |
| Primary analysis | 0·81 | 0·62–1·07 | 0·84 | 0·61–1·16 | 0·69 | 0·44–1·07 | 1·51 | 0·62–3·67 | 0·87 | 0·70–1·09 | 0·71 | 0·56–0·91 | 0·86 | 0·64–1·16 |
CCAE=IBM Commercial Claims and Encounters. CPRD=Clinical Practice Research Datalink. HCQ=hydroxychloroquine. JMDC=Japanese Medical Data Center. MDCD=IBM Multi-state Medicaid. MDCR=IBM Medicare Supplemental Database. NA=non-applicable (not reported because of failed diagnostics or on-treatment follow-up unavailable). VA=US Department of Veterans Affairs.
*
Adjusted for event-dependent observation.