Comparison · NCT02334306-sae
Any MEDI5872 210 mg 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. Any MEDI5872 210 mg vs Placebo: serious adverse events. Trial comparisons, record NCT02334306-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02334306-sae
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 | 0.0323 | 0.00572 | 0.162 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0323 | -0.163 | 0.162 | 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 harm, for one more participant with a serious adverse event on Any MEDI5872 210 mg than on Placebo | 31 | 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. | 1 | 31 | EG001 |
| 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. | 0 | 16 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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 1 participant from 'Placebo' arm discontinued treatment before Day 99, didn't receive MEDI5872 dose and entered in safety follow-up 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02334306-sae