Supplementary file 1_Efficacy and safety of Songjiao Dihuang Tang decoction for the dynami

A study protocol and statistical analysis plan for a prospective, multicentre, randomized controlled trial. The document details a trial involving 200 patients with mild immune checkpoint inhibitor-associated myocarditis, registered retrospectively on 16 July 2025. It describes the 'stop&go' adaptive design, treatment regimens, and outcome measures for evaluating the efficacy and safety of Songjiao Dihuang Tang decoction.

Use Cases

• Designing adaptive clinical trials based on the described 'stop&go' methodology.
• Analyzing cardiac biomarker (cTn) recovery patterns in immunotherapy-associated myocarditis.
• Studying corticosteroid tapering protocols in conjunction with Traditional Chinese Medicine.
• Evaluating composite clinical endpoints (MACE, symptoms, quality of life) in oncology cardiology.

Strengths

• Protocol details a specific, pre-defined statistical analysis plan for 200 patients.
• Describes a multicentre, double-blind, randomized controlled trial design with a 'stop&go' adaptive component.
• Explicitly lists primary (cTn recovery time, treatment efficacy rate) and secondary outcomes.

Limitations

• The dataset is a PDF protocol document; the underlying clinical trial data is not included.
• Column-level documentation for the trial data is absent; field semantics must be inferred from the protocol.
• Row count for the actual trial data is unknown, which may limit suitability assessment.

Provenance

Source

figshare

Collection Method

Clinical trial study protocol and statistical analysis plan.

Freshness

Last updated 2026-05-12 05:26:48; freshness should be verified.