Comparison · NCT03443973-ab6c5f8d
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) vs Gantenerumab (DBT) to Gantenerumab: OLE: OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI). Trial comparisons, record NCT03443973-ab6c5f8d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03443973-ab6c5f8d
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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 | 0 | 0.228 | wilson | |
| Risk in group 2 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0714 | -0.315 | 0.164 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) than on Gantenerumab (DBT) to Gantenerumab: OLE | 14 | 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 | Placebo (DBT) to Gantenerumab: Open-label Extension (OLE) | Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo. | 0 | 13 | OG000 |
| Group 2 | Gantenerumab (DBT) to Gantenerumab: OLE | Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period. | 1 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
- Description
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
- Time frame
- From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
- Population
- MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03443973
- Phases
- PHASE3
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-01-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03443973?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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