Comparison · NCT03181893-92937b4b
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 vs (Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12: Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)
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. (Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 vs (Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12: Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3). Trial comparisons, record NCT03181893-92937b4b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03181893-92937b4b
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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 | 0 | 0.299 | wilson | |
| Risk in group 2 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk difference, group 1 minus group 2 | -0.111 | -0.435 | 0.202 | 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 fewer participant with the outcome on (Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 than on (Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 | 9 | from the risk difference interval | the interval includes no difference |
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 | (Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 | Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study. | 0 | 9 | OG000 |
| Group 2 | (Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 | Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study. | 1 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)
- Description
Hemoglobin(HGB),hematocrit,erythrocytes(ery.),HDL cholesterol(chl.)\<0.8\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery.(%)\<0.5\*LLN,\>1.5\*upper limit of normal (ULN);ery. mean corpuscular(EMC) volume,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN; leukocytes(leu.),glucose\<0.6\*LLN,\>1.5\*ULN;lymphocytes(lym.), lym./leu.(%),neutrophils (neu.), neu./leu.(%), protein,albumin\<0.8\*LLN,\>1.2\*ULN;basophils(bas.), bas./leu.(%), eosinophils(eos.), eos./leu., monocytes(mon.), mon./leu.(%), urate\>1.2\*ULN;bilirubin (total, direct,indirect)\>1.5\*ULN;aspartate/alanine aminotransferase,gamma glutamyl transferase,lactate dehydrogenase,alkaline phosphatase\>3.0\*ULN;urea nitrogen,creatinine,triglycerides, chl.\>1.3\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; creatine kinase \>2.0\*ULN;Urine: pH\<4.5,\>8;glucose, ketones,protein, HGB,urobilinogen,bilirubin,nitrite,leukocyte esterase\>=1;ery., leu.\>= 20;hyaline casts\>1;bacteria\>20.
- Time frame
- Up to Week 40
- Population
- The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.
Source ClinicalTrials.gov
Trial
- Title
- A Study In Adults With Moderate To Severe Dermatomyositis
- NCT number
- NCT03181893
- Phases
- PHASE2
- Conditions
- Dermatomyositis
- Interventions
- PF-06823859 low, Placebo Arm, PF-06823859 high
- Lead sponsor
- Pfizer
- Results first posted
- 2023-09-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03181893?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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