Comparison · NCT01707992-078b2a77
Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
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. Active Treatment Phase: Laquinimod 0.6 mg vs Active Treatment Phase: Laquinimod 1.2 mg: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry. Trial comparisons, record NCT01707992-078b2a77. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01707992-078b2a77
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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 | 0.996 | 0.989 | 0.998 | wilson | |
| Risk in group 2 | 0.994 | 0.983 | 0.998 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00146 | -0.00656 | 0.0132 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.993 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.296 | 5.96 | log | |
| Number needed to treat, for one more participant with the outcome on Active Treatment Phase: Laquinimod 0.6 mg than on Active Treatment Phase: Laquinimod 1.2 mg | 684 | 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 | Active Treatment Phase: Laquinimod 0.6 mg | Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months. | 887 | 891 | OG000 |
| Group 2 | Active Treatment Phase: Laquinimod 1.2 mg | Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months. | 501 | 504 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
- Description
Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\>=3 \* ULN; Fibrinogen \>=6 gm/L; Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \>=28 micromols per liter (micromols/L); Creatinine \>=117 micromols/L; Albumin \<=25 gm/L.
- Time frame
- Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
- Population
Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.
Source ClinicalTrials.gov
Trial
- Title
- The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
- NCT number
- NCT01707992
- Phases
- PHASE3
- Conditions
- Multiple Sclerosis
- Interventions
- Laquinimod, Placebo
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2019-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01707992?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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