Comparison · NCT03443973-05dadd7c
Placebo: DBT vs Gantenerumab: DBT: DBT Period: Number of Participants With ARIA-H Confirmed by 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 vs Gantenerumab: DBT: DBT Period: Number of Participants With ARIA-H Confirmed by MRI. Trial comparisons, record NCT03443973-05dadd7c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03443973-05dadd7c
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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 | 0.121 | 0.0948 | 0.154 | wilson | |
| Risk in group 2 | 0.22 | 0.186 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0985 | -0.145 | -0.0512 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.552 | 0.411 | 0.741 | log | |
| Odds ratio, group 1 over group 2 | 0.49 | 0.346 | 0.695 | log | |
| Number needed to treat, for one fewer participant with the outcome on Placebo: DBT than on Gantenerumab: DBT | 10.2 | 6.89 | 19.5 | from the risk difference interval |
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 | Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period. | 57 | 470 | OG000 |
| Group 2 | Gantenerumab: DBT | Participants 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 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period. | 109 | 496 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DBT Period: Number of Participants With ARIA-H Confirmed by MRI
- Description
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
- Time frame
- From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 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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