Myasthenia Gravis
Conditions
Keywords
myasthenia gravis, thymectomy, prednisone, corticosteroid, extended transsternal thymectomy, ETTX, MG, thymus, thymoma
Brief summary
The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
Detailed description
Myasthenia gravis (MG) is an autoimmune disease involving the thymus in which 85 percent of patients have antibodies to muscle acetylcholine receptors (AchR-Ab) that interfere with neuromuscular transmission. MG frequently causes severe disability that can be life-threatening. Thymectomy-a surgical procedure that removes thymus gland tissue from the chest cavity-has been an established therapy for non-thymomatous MG, or MG without thymoma, for more than 60 years (based on retrospective, non-randomized studies). Corticosteroids are now being used increasingly either as the sole treatment or in combination with thymectomy. Both therapies have associated adverse effects and indications for their use based on randomized trial data are lacking. The purpose of this 5-year trial is to determine if the surgical procedure, extended transsternal thymectomy (ETTX), combined with prednisone therapy is more beneficial in treating individuals with non-thymomatous MG than prednisone therapy alone. More specifically, this study will determine 1) if ETTX combined with prednisone results in a greater improvement in myasthenic weakness, compared to prednisone alone; 2) if ETTX combined with prednisone results in a lower total dose of prednisone, thus decreasing the likelihood of concurrent and long-term toxic effects, compared to prednisone alone; and 3) if ETTX combined with prednisone enhances quality of life by reducing adverse events and symptoms associated with the therapies, compared to prednisone alone. Learning that thymectomy results in a meaningful reduction of prednisone dosage or even full withdrawal or reduces side effects related to prednisone would support using the two treatments-thymectomy and prednisone-together. However, if no meaningful reduction of prednisone dosage or side effects is shown, the results would mean that using the two treatments together offers no advantages over prednisone treatment alone. After an initial screening, study participants will be randomized either to undergo the surgical procedure ETTX and receive prednisone treatment, or to receive prednisone treatment alone without surgery. Participants will be followed for at least 3 years.
Interventions
PROCEDUREthymectomy plus prednisone
The thymectomy will be performed as soon as possible after randomization.
DRUGprednisone alone
Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female MG patients age greater than 18 and less than 65 years * Onset of generalized MG within the last 5 years * Positive serum anti-acetylcholine receptor binding antibodies (muscle acetylcholine receptors, AchRAb =/\> 1.00 nmol/L. AchRAb levels of 0.50-0.99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium testing.) * MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone
Exclusion criteria
* Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids * Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month * Immunosuppressive therapy other than corticosteroids in the preceding year * Medically unfit for thymectomy * Chest CT evidence of thymoma. * Pregnancy or lactation; contraindications to the use of corticosteroids, unless postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded. * A serious concurrent medical, neurological or psychiatric condition that would interfere with thymectomy or subsequent clinical assessments * Current alternate day dose of prednisone \> than 1.5 mg/kg or 100 mg or the equivalent daily doses (\> 0.75 mg/kg or 50 mg). * Participation in another experimental clinical trial * History of alcohol or drug abuse within the 2 years prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
| 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) |
| Classification of Serious Adverse Events | baseline to 3 years | — |
| Hospitalization for Exacerbation of Myasthenia Gravis | baseline to 2 years and baseline to 3 years | — |
| 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) |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Azathioprine Use | baseline to 3 years | — |
| Plasma Exchange Use | baseline to 3 years | — |
| Intravenous Immunoglobulin Use | baseline to 3 years | — |
| Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 12, 24 and 36 | Number of participants who were in minimal manifestation status at month 12, 24 and 36. |
| Cumulative Days in Hospital for Myasthenia Gravis Exacerbation | baseline to 2 years | Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60) |
| Short Form-36 Standardized Physical Component | Month 0, Month 12, Month 24 and Month 36 | Range from 0 to 100, the higher the physical component value, the better the mental health. |
| Short Form-36 Standardized Mental Component | Month 0, Month 12, Month 24 and Month 36 | Range from 0 to 100, the higher the mental component value, the better the mental health. |
| Treatment Associated Complications (TAC) | Month 0, 1, 2, 3, 4 then every 3 months through Month 36 | Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit. |
| Treatment Associated Symptoms (TAS) | Month 0, 1, 2, 3, 4 then every 3 months through Month 36 | Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit. |
| 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. |
| 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. |
Countries
Argentina, Australia, Brazil, Canada, Chile, Germany, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Participant flow
Recruitment details
The first enrollment of two patients started with July 26, 2006 and the last patient was recruited on November 28, 2012. Of the 126 randomized patients, 96 were from centers outside the US and 30 were from US centers.
Pre-assignment details
After informed consent signed, 66 patients were randomized to extended transsternal thymectomy with prednisone treatment and 60 patients were assigned to take prednisone without surgery. Within the 126 subject that started, 15 dropped out before 3 year follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Thymectomy Plus Prednisone Procedure: Extended Transsternal Thymectomy plus prednisone treatment
thymectomy: The thymectomy will be performed as soon as possible after randomization. | 66 |
| Prednisone Alone Drug: prednisone alone protocol
prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose. | 60 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Found to have invasive thymoma | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Patient and family were not satisfied | 0 | 1 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Prednisone Alone | Total | Thymectomy Plus Prednisone |
|---|---|---|---|
| Age, Continuous | 33 years | 32 years | 32 years |
| Duration of disease | 1.14 years | 1.11 years | 1.08 years |
| MGFA class IIa | 25 participants | 50 participants | 25 participants |
| MGFA class IIb | 14 participants | 32 participants | 18 participants |
| MGFA class III | 20 participants | 41 participants | 21 participants |
| MGFA class IV | 1 participants | 3 participants | 2 participants |
| Prednisone Dosage at baseline (mg) | 42.49 mg STANDARD_DEVIATION 23.52 | 42.97 mg STANDARD_DEVIATION 26.28 | 43.43 mg STANDARD_DEVIATION 28.92 |
| Prednisone use at baseline Missing | 3 participants | 4 participants | 1 participants |
| Prednisone use at baseline No | 10 participants | 26 participants | 16 participants |
| Prednisone use at baseline Yes | 47 participants | 96 participants | 49 participants |
| Previous therapy - Intravenous immue globulin Missing | 3 participants | 4 participants | 1 participants |
| Previous therapy - Intravenous immue globulin No | 44 participants | 97 participants | 53 participants |
| Previous therapy - Intravenous immue globulin Yes | 13 participants | 25 participants | 12 participants |
| Previous therapy - Plasma exchange Missing | 3 participants | 4 participants | 1 participants |
| Previous therapy - Plasma exchange No | 50 participants | 106 participants | 56 participants |
| Previous therapy - Plasma exchange Yes | 7 participants | 16 participants | 9 participants |
| QMG score | 12.35 units on a scale STANDARD_DEVIATION 4.9 | 11.84 units on a scale STANDARD_DEVIATION 5.02 | 11.40 units on a scale STANDARD_DEVIATION 5.12 |
| Race/Ethnicity, Customized Asian | 4 participants | 10 participants | 6 participants |
| Race/Ethnicity, Customized Black | 6 participants | 13 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic | 17 participants | 34 participants | 17 participants |
| Race/Ethnicity, Customized Non-Hispanic | 30 participants | 61 participants | 31 participants |
| Race/Ethnicity, Customized Other | 3 participants | 8 participants | 5 participants |
| Region of Enrollment Argentina | 11 participants | 21 participants | 10 participants |
| Region of Enrollment Australia | 2 participants | 4 participants | 2 participants |
| Region of Enrollment Brazil | 2 participants | 5 participants | 3 participants |
| Region of Enrollment Canada | 9 participants | 18 participants | 9 participants |
| Region of Enrollment Chile | 5 participants | 10 participants | 5 participants |
| Region of Enrollment Germany | 3 participants | 5 participants | 2 participants |
| Region of Enrollment Italy | 4 participants | 10 participants | 6 participants |
| Region of Enrollment Japan | 1 participants | 2 participants | 1 participants |
| Region of Enrollment Mexico | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Netherlands | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Poland | 1 participants | 2 participants | 1 participants |
| Region of Enrollment South Africa | 4 participants | 8 participants | 4 participants |
| Region of Enrollment Thailand | 2 participants | 5 participants | 3 participants |
| Region of Enrollment United Kingdom | 2 participants | 4 participants | 2 participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 39 Participants | 89 Participants | 50 Participants |
| Sex: Female, Male Male | 21 Participants | 37 Participants | 16 Participants |
| Therapy at enrollment - Glucocorticoid Missing | 3 participants | 4 participants | 1 participants |
| Therapy at enrollment - Glucocorticoid No | 10 participants | 26 participants | 16 participants |
| Therapy at enrollment - Glucocorticoid Yes | 47 participants | 96 participants | 49 participants |
| Therapy at enrollment - Pyridostigimine Missing | 3 participants | 4 participants | 1 participants |
| Therapy at enrollment - Pyridostigimine No | 1 participants | 6 participants | 5 participants |
| Therapy at enrollment - Pyridostigimine Yes | 56 participants | 116 participants | 60 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 66 | 48 / 60 |
| serious Total, serious adverse events | 25 / 66 | 33 / 60 |
Outcome results
Primary
Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
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.
Time frame: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | 32 mg | Standard Deviation 23 |
| Prednisone Alone | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years | 54 mg | Standard Deviation 29 |
Primary
Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years
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.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | 6.15 units on a scale | Standard Deviation 4.09 |
| Prednisone Alone | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years | 8.99 units on a scale | Standard Deviation 4.93 |
Secondary
Azathioprine Use
Time frame: baseline to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymectomy Plus Prednisone | Azathioprine Use | 11 participants |
| Prednisone Alone | Azathioprine Use | 28 participants |
Secondary
Classification of Serious Adverse Events
Time frame: baseline to 3 years
Population: One participant might had experienced more than one serious adverse event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Life-threatening | 1 participants |
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Disability or incapacity | 8 participants |
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Medical or surgical intervention | 9 participants |
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Death | 0 participants |
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Complication due to thytmectomy | 1 participants |
| Thymectomy Plus Prednisone | Classification of Serious Adverse Events | Hospitalization | 15 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Complication due to thytmectomy | 0 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Life-threatening | 7 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Death | 1 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Disability or incapacity | 2 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Hospitalization | 31 participants |
| Prednisone Alone | Classification of Serious Adverse Events | Medical or surgical intervention | 5 participants |
Secondary
Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)
Time frame: baseline to 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation | 8.7 days | Standard Deviation 7.7 |
| Prednisone Alone | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation | 22.5 days | Standard Deviation 27.1 |
Secondary
Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)
Time frame: baseline to 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation | 5.5 days | Standard Deviation 2.9 |
| Prednisone Alone | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation | 26.4 days | Standard Deviation 28.9 |
Secondary
Cumulative Number of Hospital Days
Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)
Time frame: baseline to 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Cumulative Number of Hospital Days | 8.4 days | Standard Deviation 8.6 |
| Prednisone Alone | Cumulative Number of Hospital Days | 19.2 days | Standard Deviation 24.5 |
Secondary
Hospitalization for Exacerbation of Myasthenia Gravis
Time frame: baseline to 2 years and baseline to 3 years
Population: Number of participants who had hospitalized over 2 and 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Hospitalization for Exacerbation of Myasthenia Gravis | Months 0-24 | 6 participants |
| Thymectomy Plus Prednisone | Hospitalization for Exacerbation of Myasthenia Gravis | Months 0-36 | 6 participants |
| Prednisone Alone | Hospitalization for Exacerbation of Myasthenia Gravis | Months 0-24 | 17 participants |
| Prednisone Alone | Hospitalization for Exacerbation of Myasthenia Gravis | Months 0-36 | 22 participants |
Secondary
Intravenous Immunoglobulin Use
Time frame: baseline to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymectomy Plus Prednisone | Intravenous Immunoglobulin Use | 11 participants |
| Prednisone Alone | Intravenous Immunoglobulin Use | 23 participants |
Secondary
Minimal Manifestation (MM) Status at Month 12, 24 and 36
Number of participants who were in minimal manifestation status at month 12, 24 and 36.
Time frame: Month 12, 24 and 36
Population: Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 12 | 41 participants |
| Thymectomy Plus Prednisone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 24 | 39 participants |
| Thymectomy Plus Prednisone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 36 | 39 participants |
| Prednisone Alone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 12 | 20 participants |
| Prednisone Alone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 24 | 20 participants |
| Prednisone Alone | Minimal Manifestation (MM) Status at Month 12, 24 and 36 | Month 36 | 24 participants |
Secondary
Number of Patients With at Least One Serious Adverse Events
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)
Time frame: baseline to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymectomy Plus Prednisone | Number of Patients With at Least One Serious Adverse Events | 25 participants |
| Prednisone Alone | Number of Patients With at Least One Serious Adverse Events | 33 participants |
Secondary
Number of Serious Adverse Events
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)
Time frame: baseline to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymectomy Plus Prednisone | Number of Serious Adverse Events | 48 events |
| Prednisone Alone | Number of Serious Adverse Events | 93 events |
Secondary
Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)
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.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine) | 34.4 mg | Standard Deviation 28.2 |
| Prednisone Alone | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine) | 64.4 mg | Standard Deviation 40.8 |
Secondary
Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)
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.
Time frame: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine) | 33.3 mg | Standard Deviation 27.2 |
| Prednisone Alone | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine) | 57.9 mg | Standard Deviation 36.9 |
Secondary
Plasma Exchange Use
Time frame: baseline to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymectomy Plus Prednisone | Plasma Exchange Use | 10 participants |
| Prednisone Alone | Plasma Exchange Use | 9 participants |
Secondary
Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term
Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)
Time frame: baseline to 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Metabolism or nutrition disorder | 1 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Nervous system disorder | 8 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Infection or infestation | 4 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Respiratory, thoracic, or mediastinal disorder | 1 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Hepatobiliary disorder | 0 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Surgical or medical procedure | 0 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Injury, poisoning, or procedure complication | 2 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Vascular disorder | 0 events |
| Thymectomy Plus Prednisone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Gastrointestinal disorder | 2 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Vascular disorder | 1 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Gastrointestinal disorder | 2 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Hepatobiliary disorder | 1 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Infection or infestation | 7 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Injury, poisoning, or procedure complication | 0 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Nervous system disorder | 22 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Respiratory, thoracic, or mediastinal disorder | 2 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Surgical or medical procedure | 7 events |
| Prednisone Alone | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term | Metabolism or nutrition disorder | 0 events |
Secondary
Short Form-36 Standardized Mental Component
Range from 0 to 100, the higher the mental component value, the better the mental health.
Time frame: Month 0, Month 12, Month 24 and Month 36
Population: Participants were in and out by visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Short Form-36 Standardized Mental Component | Month 0 | 49.1 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Mental Component | Month 12 | 39.1 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Mental Component | Month 24 | 49.9 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Mental Component | Month 36 | 51.7 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Mental Component | Month 36 | 48.2 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Mental Component | Month 0 | 46.2 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Mental Component | Month 24 | 46.7 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Mental Component | Month 12 | 41.7 units on a scale |
Secondary
Short Form-36 Standardized Physical Component
Range from 0 to 100, the higher the physical component value, the better the mental health.
Time frame: Month 0, Month 12, Month 24 and Month 36
Population: Participants were in and out by visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Short Form-36 Standardized Physical Component | Month 36 | 48.2 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Physical Component | Month 0 | 41.4 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Physical Component | Month 12 | 48.4 units on a scale |
| Thymectomy Plus Prednisone | Short Form-36 Standardized Physical Component | Month 24 | 50.3 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Physical Component | Month 24 | 43.0 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Physical Component | Month 36 | 44.2 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Physical Component | Month 12 | 44.4 units on a scale |
| Prednisone Alone | Short Form-36 Standardized Physical Component | Month 0 | 37.9 units on a scale |
Secondary
Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment
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.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | Not prednisone naïve | 35 mg | Standard Deviation 25 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | Prednisone naïve | 25 mg | Standard Deviation 17 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | Not prednisone naïve | 56 mg | Standard Deviation 31 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment | Prednisone naïve | 45 mg | Standard Deviation 22 |
Secondary
Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex
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.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | Female | 33 mg | Standard Deviation 25 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | Male | 31 mg | Standard Deviation 18 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | Female | 54 mg | Standard Deviation 27 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex | Male | 55 mg | Standard Deviation 34 |
Secondary
Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset
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.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | Age (Years) at Disease Onset ≥ 40 | 27 mg | Standard Deviation 18 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | Age (Years) at Disease Onset < 40 | 35 mg | Standard Deviation 25 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | Age (Years) at Disease Onset < 40 | 55 mg | Standard Deviation 30 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset | Age (Years) at Disease Onset ≥ 40 | 49 mg | Standard Deviation 29 |
Secondary
Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | Age (years) at Disease Onset < 40 | 6.50 units on a scale | Standard Deviation 4.41 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | Age (years) at Disease Onset ≥ 40 | 5.33 units on a scale | Standard Deviation 2.79 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | Age (years) at Disease Onset < 40 | 9.60 units on a scale | Standard Deviation 5.32 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset | Age (years) at Disease Onset ≥ 40 | 7.85 units on a scale | Standard Deviation 3.5 |
Secondary
Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Not prednisone naïve | 6.30 units on a scale | Standard Deviation 3.89 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Prednisone naïve | 5.66 units on a scale | Standard Deviation 4.79 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Not prednisone naïve | 9.10 units on a scale | Standard Deviation 5.06 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment | Prednisone naïve | 8.84 units on a scale | Standard Deviation 4.6 |
Secondary
Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.
Time frame: baseline, month 3, 4, 6 and every 3 months through 36 months
Population: Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Female | 6.47 units on a scale | Standard Deviation 4.13 |
| Thymectomy Plus Prednisone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Male | 5.23 units on a scale | Standard Deviation 3.95 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Male | 7.45 units on a scale | Standard Deviation 4.11 |
| Prednisone Alone | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex | Female | 9.73 units on a scale | Standard Deviation 5.16 |
Secondary
Time-Weighted Average MG Activity of Daily Living (MG-ADL)
MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.
Time frame: baseline, month 4, 6 and every 3 months through 36 months
Population: Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) | 2.24 units on a scale | Standard Deviation 2.09 |
| Prednisone Alone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) | 3.41 units on a scale | Standard Deviation 2.58 |
Secondary
Time-Weighted Average MG Activity of Daily Living (MG-ADL) at 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.
Time frame: Month 12, 24, and 36
Population: Participants were in and out at month 12, 24 and 36 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thymectomy Plus Prednisone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 36 | 2.14 units on a scale | Standard Deviation 2.92 |
| Thymectomy Plus Prednisone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 12 | 1.92 units on a scale | Standard Deviation 2.73 |
| Thymectomy Plus Prednisone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 24 | 2.02 units on a scale | Standard Deviation 2.78 |
| Prednisone Alone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 24 | 3.11 units on a scale | Standard Deviation 2.93 |
| Prednisone Alone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 36 | 2.69 units on a scale | Standard Deviation 2.8 |
| Prednisone Alone | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 | Month 12 | 3.33 units on a scale | Standard Deviation 3.4 |
Secondary
Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)
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.
Time frame: baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months
Population: Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thymectomy Plus Prednisone | Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg) | 34.3 mg | Standard Deviation 22.7 |
| Prednisone Alone | Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg) | 55.6 mg | Standard Deviation 29.4 |
Secondary
Treatment Associated Complications (TAC)
Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.
Time frame: Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Population: Participants were in and out by each visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 36 | 23 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 15 | 29 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 0 | 22 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 1 | 15 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 2 | 22 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 3 | 21 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 4 | 23 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 6 | 21 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 9 | 37 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 12 | 35 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 18 | 28 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 21 | 22 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Mpnth 24 | 28 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Mpnth 27 | 25 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 30 | 23 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Complications (TAC) | Month 33 | 24 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 36 | 23 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 0 | 17 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 12 | 28 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 15 | 24 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Mpnth 27 | 17 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 1 | 15 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 18 | 24 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 2 | 20 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 33 | 23 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 3 | 16 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 21 | 20 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 4 | 23 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 30 | 19 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 6 | 22 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Mpnth 24 | 23 Participants |
| Prednisone Alone | Treatment Associated Complications (TAC) | Month 9 | 26 Participants |
Secondary
Treatment Associated Symptoms (TAS)
Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.
Time frame: Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Population: Patients were in and out by visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 0 | 63 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Mpnth 27 | 50 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 1 | 55 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 2 | 61 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 3 | 60 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 4 | 59 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 6 | 60 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 9 | 59 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 12 | 56 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 15 | 56 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 18 | 52 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 21 | 52 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Mpnth 24 | 52 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 30 | 49 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 33 | 51 Participants |
| Thymectomy Plus Prednisone | Treatment Associated Symptoms (TAS) | Month 36 | 49 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 36 | 47 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 0 | 53 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 12 | 52 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Mpnth 27 | 50 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Mpnth 24 | 51 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 1 | 52 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 15 | 51 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 2 | 53 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 33 | 48 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 3 | 54 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 18 | 51 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 4 | 54 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 30 | 50 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 6 | 53 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 21 | 50 Participants |
| Prednisone Alone | Treatment Associated Symptoms (TAS) | Month 9 | 50 Participants |