Trial · NCT00294658
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | baseline, month 3, 4, 6 and every 3 months through 36 months | Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization. |
| Primary | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months | Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. |
| Secondary | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | baseline, month 3, 4, 6 and every 3 months through 36 months | Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. |
| Secondary | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | baseline, month 3, 4, 6 and every 3 months through 36 months | Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. |
| Secondary | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | baseline, month 3, 4, 6 and every 3 months through 36 months | Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. |
| Secondary | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | baseline, month 3, 4, 6 and every 3 months through 36 months | Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. |
| Secondary | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | baseline, month 3, 4, 6 and every 3 months through 36 months | Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. |
| Secondary | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | baseline, month 3, 4, 6 and every 3 months through 36 months | Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. |
| Secondary | Number of Serious Adverse Events | baseline to 3 years | Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) |
| Secondary | Number of Patients With at Least One Serious Adverse Events | baseline to 3 years | Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) |
| Secondary | Classification of Serious Adverse Events | baseline to 3 years | |
| Secondary | Hospitalization for Exacerbation of Myasthenia Gravis | baseline to 2 years and baseline to 3 years | |
| Secondary | Cumulative Number of Hospital Days | baseline to 3 years | Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) |
| Secondary | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | baseline to 3 years | Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) |
| Secondary | Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg) | baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months | Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period. |
| Secondary | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine) | baseline, month 3, 4, 6 and every 3 months through 36 months | For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. |
| Secondary | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine) | baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months | For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. |
| Secondary | Time-Weighted Average MG Activity of Daily Living (MG-ADL) | baseline, month 4, 6 and every 3 months through 36 months | MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life. |
| Secondary | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 12, 24, and 36 | MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life. |
| Secondary | Azathioprine Use | baseline to 3 years |
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/NCT00294658/registered