N/A
Completed N=1,161
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
Source: ClinicalTrials.gov NCT01013350 ↗Enrolled (actual)
1,161
Serious AEs
6.4%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Serious Adverse Drug Reactions (SADRs) — 1; 14 Participants
Summary
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Drug Reactions (SADRs) |
1; 14 | — |
| PRIMARY Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia |
30.22 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC |
18; 92; 4; 25 | — |
| SECONDARY Number of Participants With Pregnancy Outcomes |
23; 39; 3; 3; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended
- Written informed consent was given
Exclusion Criteria
- Participants who cannot be reached by telephone
- Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
- Participants who - either during the lag interval or subsequently enter an interventional study
Data sourced from ClinicalTrials.gov (NCT01013350). 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.