Comparison · NCT01380990-sae
OTL-101* On-Study and CUP Subjects vs OTL-101* On-Study Subjects: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. OTL-101* On-Study and CUP Subjects vs OTL-101* On-Study Subjects: serious adverse events. Trial comparisons, record NCT01380990-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01380990-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.55 | 0.342 | 0.742 | wilson | |
| Risk in group 2 | 0.7 | 0.397 | 0.892 | wilson | |
| Risk difference, group 1 minus group 2 | -0.15 | -0.433 | 0.209 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.786 | 0.446 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 0.524 | 0.104 | 2.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on OTL-101* On-Study and CUP Subjects than on OTL-101* On-Study Subjects | 6.67 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | OTL-101* On-Study and CUP Subjects | The safety population consists of all OTL-101\*-treated subjects (on-study and CUP). | 11 | 20 | EG000 |
| Group 2 | OTL-101* On-Study Subjects | The safety population for analysis consists of the on-study OTL-101\*-treated subjects. | 7 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported from the time of participant consent, approximately 1-month pre-treatment, up until 3-years post-treatment with OTL-101*
Source ClinicalTrials.gov
Trial
- Title
- Lentiviral (LV) Gene Therapy for Adenosine Deaminase (ADA) Deficiency
- NCT number
- NCT01380990
- Phases
- PHASE1, PHASE2
- Conditions
- Adenosine Deaminase Deficiency, Severe Combined Immunodeficiencies (SCID)
- Interventions
- Infusion of autologous EFS-ADA LV CD34+ cells, Haematopoietic Stem Cell Transplantation (HSCT), Busulfan, Peg-Ada
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Results first posted
- 2021-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01380990?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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