Comparison · NCT03444870-da2096df
China Extension - DBT Period: Gantenerumab vs China Extension - DBT Period: Placebo: China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
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. China Extension - DBT Period: Gantenerumab vs China Extension - DBT Period: Placebo: China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding. Trial comparisons, record NCT03444870-da2096df. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03444870-da2096df
On this page
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 | 0.0286 | 0.00506 | 0.145 | wilson | |
| Risk in group 2 | 0 | 0 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0286 | -0.0783 | 0.145 | 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 more participant with the outcome on China Extension - DBT Period: Gantenerumab than on China Extension - DBT Period: Placebo | 35 | 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 | China Extension - DBT Period: Gantenerumab | Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period. | 1 | 35 | OG001 |
| Group 2 | China Extension - DBT Period: Placebo | Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period. | 0 | 33 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
- 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 124 weeks)
- Population
- SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- NCT number
- NCT03444870
- Phases
- PHASE3
- Conditions
- Alzheimer Disease
- Interventions
- Gantenerumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03444870?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03444870-da2096df