Comparison · NCT02334306-8dc5b028
Any MEDI5872 210 mg vs Placebo: Number of Participants With Adverse Events of Special Interest (AESIs)
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. Any MEDI5872 210 mg vs Placebo: Number of Participants With Adverse Events of Special Interest (AESIs). Trial comparisons, record NCT02334306-8dc5b028. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02334306-8dc5b028
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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 | 0.194 | 0.0919 | 0.363 | wilson | |
| Risk in group 2 | 0.0625 | 0.0111 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | -0.112 | 0.308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.1 | 0.407 | 23.6 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.394 | 32.9 | log | |
| Number needed to treat, for one more participant with the outcome on Any MEDI5872 210 mg than on Placebo | 7.63 | 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 | Any MEDI5872 210 mg | Participants received at least one dose of MEDI5872 treatment either during double-blind and/or open-label period of the study.~In double-bind period, participants received a fixed SC dose of 210 mg MEDI5872 QW for 3 weeks (Days 1, 8, and 15) and then every Q2W for 9 weeks (Days 29 to 85).~In open-label period, participants who received MEDI5872 210mg in double-blinded period received MEDI5872 210mg on Days 99 and Day 113; and participants who received placebo in double-blinded period received MEDI5872 210mg QW from Days 99 to 113, later all participants received MEDI5872 210mg Q2W from Days 127 to 183 and were followed up till Day 296. | 6 | 31 | OG001 |
| Group 2 | Placebo | Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. | 1 | 16 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events of Special Interest (AESIs)
- Description
An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, new or reactivated tuberculosis infection, malignancy, and hypersensitivity and anaphylactic reactions. Treatment-emergent AESIs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm.
- Time frame
Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period
- Population
Placebo: As-treated population (participants grouped per actual treatment received).~Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from 'Placebo' discontinued treatment before Day 99 and didn't receive MEDI5872 dose in open-label period.
Source ClinicalTrials.gov
Trial
- Title
- A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
- NCT number
- NCT02334306
- Phases
- PHASE2
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- AMG 557/MEDI5872, Placebo
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2019-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02334306?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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