N/A
Completed N=251
Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Acromegaly
Source: ClinicalTrials.gov NCT00658879 ↗
Enrolled (actual)
251
Serious AEs
15.6%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events — 89; 20 Participants
Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
89; 20 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
9 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Gender |
52; 37 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Age |
2; 75; 12 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder |
85; 4 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment |
88; 1 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) |
57; 32 | — |
| PRIMARY Clinical Effectiveness Rate |
96.4 | — |
| PRIMARY Clinical Effectiveness Rate by Gender |
96.8; 96.0 | — |
| PRIMARY Clinical Effectiveness Rate by Age |
50.0; 96.1; 100.0 | — |
| PRIMARY Clinical Effectiveness Rate in Participants With Hepatic Function Disorder |
96.7; 92.3 | — |
| PRIMARY Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) |
96.0; 97.0 | — |
Eligibility Criteria
Inclusion Criteria
Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.
Exclusion Criteria
Patients not administered Somavert (Pegvisomant).
Data sourced from ClinicalTrials.gov (NCT00658879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.