JV15823.
| Methods | Randomised, placebo‐controlled, multicentre study of oseltamivir (Ro 64‐0796) in the treatment of influenza in Japanese participants | |
| Participants | Over 16 years of age; present within 36 hours of onset of symptoms of fever > 38.0 °C, plus 2 influenza symptoms | |
| Interventions | 75 mg capsules, Ro 64‐0796/V14 batch no. GMZ 0129/03 Matching placebo capsules: Ro 64‐0796/V16 batch no. GMZ 0136 |
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| Outcomes |
Primary outcome The time to alleviation of all symptoms Secondary outcomes Total symptom score AUC Change in virus titre Time to return to the afebrile state Adverse events |
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| Notes | The available study report is a 29‐page document in Japanese. The design and methods are similar to those of WV 15670 and 15671 (the "pivotal" treatment trials in adults) and the trial was intended as a "bridge" with the Western trial programme. The report does not contain any supporting data (i.e. statistical analysis plan, protocol, amendments, certificates of analysis and audit, randomisation lists, lists of investigators, IRB clearance and individual listings) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Not specified as protocol and methods section were not available |
| Allocation concealment (selection bias) | High risk | Not specified as protocol and methods section were not available |
| Incomplete outcome data (attrition bias) Symptoms | High risk | 92 participants excluded in efficacy analysis because infection with influenza virus could not be verified in the efficacy analysis |
| Incomplete outcome data (attrition bias) Complications of influenza | High risk | 92 participants excluded in efficacy analysis because infection with influenza virus could not be verified in the efficacy analysis |
| Incomplete outcome data (attrition bias) Safety data | High risk | No drop‐outs because of harms were reported but no breakdown by on‐ and off‐treatment status reported |
| Selective reporting (reporting bias) | High risk | Not specified as protocol and methods section were not available |
| Other bias | High risk | Not specified as protocol and methods section were not available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not specified as protocol and methods section were not available |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not specified as protocol and methods section were not available |