Trial · NCT01773993
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Drug Reaction | From Week 1 to 52 weeks at maximum | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Drug Reaction | From Week 1 to52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Vision-related Events | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Score at Week 52 | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of pain score was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Sleep Score at Week 52 | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of quality of sleep score was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Patient's Impression (PGIC) at Week 52 | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available among the baseline analysis population. | Participants | NUMBER |
| SECONDARY | Physician's Impression (CGIC) at Week 52 | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available among the baseline analysis population. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52 | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PHQ-9 was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of EQ-5D was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of FAS-31 was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of JFIQR was available among the baseline analysis population. | Units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01773993/outcomes