Comparison · NCT01821118-sae
PF-04360365 vs Placebo: serious adverse events
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. PF-04360365 vs Placebo: serious adverse events. Trial comparisons, record NCT01821118-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01821118-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 | 0.0833 | 0.0232 | 0.258 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0833 | -0.371 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.0799 | 3.13 | log | |
| Odds ratio, group 1 over group 2 | 0.455 | 0.0558 | 3.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PF-04360365 than on Placebo | 12 | 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 | PF-04360365 | Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight. | 2 | 24 | EG000 |
| Group 2 | Placebo | Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min. | 2 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
- NCT number
- NCT01821118
- Phases
- PHASE2
- Conditions
- Cerebral Amyloid Angiopathy
- Interventions
- Ponezumab, placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2016-11-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01821118?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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