Comparison · NCT01753076-007a41d5
Ozanezumab 15 mg/kg vs Placebo: Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48
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. Ozanezumab 15 mg/kg vs Placebo: Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48. Trial comparisons, record NCT01753076-007a41d5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01753076-007a41d5
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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 | 0.186 | 0.121 | 0.274 | wilson | |
| Risk in group 2 | 0.228 | 0.157 | 0.319 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0422 | -0.154 | 0.0715 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.815 | 0.47 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 0.773 | 0.387 | 1.54 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ozanezumab 15 mg/kg than on Placebo | 23.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ozanezumab 15 mg/kg | Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48. | 18 | 97 | OG001 |
| Group 2 | Placebo | Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48. | 23 | 101 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48
- Description
The CGI-I scale is a single observer-rated item measuring global improvement relative to Baseline. The CGI-I score is rated on a 7-point scale, from 1 (very much improved) to 7 (very much worse). Participant status at Baseline was assessed using the Clinical Global Impression Severity scale (CGI-S), which is a 7-point scale (1: normal, not at all ill; 7: most extremely ill) used to rate the severity of the participant's illness. Participants achieving a score of 1-4 in the CGI-I at Week 48 were considered to be responders. A a logistic regression adjusted for CGI-S at Baseline, riluzole use, and world region was used for the analysis.
- Time frame
- Week 48
- Population
- ITT Population. Only participants with data available at the specified time points were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis
- NCT number
- NCT01753076
- Phases
- PHASE2
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Ozanezumab, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01753076?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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