Somatrogon Phase 3 Trial Extension: 3-Year Safety and Efficacy Data

Supplementary material from a Phase 3 clinical trial extension evaluating the long-acting growth hormone somatrogon in children with growth hormone deficiency. The dataset includes safety and efficacy outcomes for up to 3 years of treatment, involving 212 patients in the first year of the open-label extension and 177 in the second. The data, published under a CC-BY-4.0 license on figshare, reports results from the NCT02968004 trial.

Use Cases

• Analyze long-term height velocity trends based on reported mean height velocity (HV) at OLE Year 1 and Year 2
• Compare treatment safety profiles based on reported adverse event incidence rates and severity
• Evaluate dose adjustment criteria based on the protocol-defined threshold for insulin-like growth factor I SDS
• Assess treatment efficacy persistence based on reported mean height SD score (SDS) changes over time

Strengths

• Data spans up to 3 years of longitudinal follow-up from a randomized controlled trial
• Includes results for 212 patients in the first extension year and 177 in the second
• Reports specific efficacy metrics like mean height velocity (8.11 cm/y in OLE Y1) and height SDS (-1.42 in OLE Y1)

Limitations

• Column-level documentation is absent; field semantics must be inferred after download
• Row count is unknown, which may limit suitability assessment
• Data is provided as a 2.2 MB PDF, which may require extraction for quantitative analysis

Provenance

Source

Clinical trial NCT02968004, published via figshare by admin karger

Collection Method

Randomized controlled trial with an open-label extension phase

Time Range

Covers up to 3 years of treatment follow-up

Freshness

Last updated 2026-06-01 07:14:37; freshness should be verified