Trial Outcomes & Findings for Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) (NCT NCT01884571)
NCT ID: NCT01884571
Last Updated: 2017-11-06
Results Overview
The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month.
COMPLETED
PHASE2
31 participants
Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
2017-11-06
Participant Flow
Participants were recruited for this study from three Northeast ALS Consortium (NEALS) centers in the USA (Emory University in Atlanta, Georgia, Massachusetts General Hospital in Boston, Massachusetts, and University of Massachusetts Medical School in Worcester, Massachusetts. Recruitment occurred between October 2013 and October 2014.
Participant milestones
| Measure |
Immunosuppression Regimen
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months.
Basiliximab: 20 mg, IV (in the vein) on day 1 and 4.
Methylprednisolone: 125 mg, IV (in the vein) on day 1.
Prednisone: 60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.
Tacrolimus: 1-5 mg PO, twice a day (BID) days 2-180.
Mycophenolate mofetil: 500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180.
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Immunosuppression Regimen
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment (described below) and the treatment period lasted for six months.
Basiliximab: 20 mg, IV (in the vein) on day 1 and 4.
Methylprednisolone: 125 mg, IV (in the vein) on day 1.
Prednisone: 60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.
Tacrolimus: 1-5 mg PO, twice a day (BID) days 2-180.
Mycophenolate mofetil: 500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Death
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2
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Disease progression
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3
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Baseline Characteristics
Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Immunosuppression Regimen
n=31 Participants
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Age, Continuous
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53.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
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Region of Enrollment
United States
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31 Participants
n=5 Participants
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Timing of Symptom Onset
Less than or equal to 24 months prior to screening
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20 Participants
n=5 Participants
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Timing of Symptom Onset
More than 24 months prior to screening
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)Population: All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used).
The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month
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0 Participants
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SECONDARY outcome
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)Population: All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used)
The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment
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-0.24 units on a scale change per month
Standard Error 0.23
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SECONDARY outcome
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)Population: All study participants who received treatment are included in the analysis for this outcome measure.
Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment
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-0.18 percent predicted change per month
Standard Error 0.63
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SECONDARY outcome
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)Population: All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early.
Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment
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-0.05 z-score change per month
Standard Error 0.03
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SECONDARY outcome
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment
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1.38 pounds change per month
Standard Error 0.65
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SECONDARY outcome
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment
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-0.04 fold change per month
Standard Error 0.03
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SECONDARY outcome
Timeframe: Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)Population: Cerebrospinal fluid was collected from 29 participants and banked for future analysis.
Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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|---|---|
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Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels
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29 Participants
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SECONDARY outcome
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)Population: Blood was collected for all 31 participants and banked for future use.
Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS.
Outcome measures
| Measure |
Immunosuppression Regimen
n=31 Participants
Participants were monitored for a three month lead-in period prior to beginning treatment. The Baseline Visit 1 occurred within 21 days after the Screening visit and 3 months prior to receiving the first does of the immunosuppressant regimen. Baseline Visits 2 and 3 occurred 2 and 1 month prior to the start of treatment.
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)
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31 Participants
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Adverse Events
Immunosuppression Regimen
Serious adverse events
| Measure |
Immunosuppression Regimen
n=31 participants at risk
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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Nervous system disorders
Hospital admission for dehyration due to dysphagia from ALS
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3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Musculoskeletal and connective tissue disorders
Hospitalization due to knee injury from a fall
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3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Renal and urinary disorders
Hospitalization due to a kidney stone
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3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Respiratory, thoracic and mediastinal disorders
Hospitalization due to pulmonary embolism
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3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Respiratory, thoracic and mediastinal disorders
Hospitalization due to bilateral pneumonia
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3.2%
1/31 • Number of events 2 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Cardiac disorders
Asymptomatic T-wave inversions with troponin elevation
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3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Other adverse events
| Measure |
Immunosuppression Regimen
n=31 participants at risk
All participants received the same treatment intervention consisting of basiliximab, methylprednisolone, prednisone, tacrolimus and mycophenolate mofetil. Doses of each medication varied by the day of treatment and the treatment period lasted for six months.
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|---|---|
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General disorders
Fall
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54.8%
17/31 • Number of events 48 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Gastrointestinal disorders
Diarrhea
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41.9%
13/31 • Number of events 17 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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|
Musculoskeletal and connective tissue disorders
Muscular Weakness
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38.7%
12/31 • Number of events 27 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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General disorders
Headache
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35.5%
11/31 • Number of events 16 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Musculoskeletal and connective tissue disorders
Muscular Spasms
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35.5%
11/31 • Number of events 14 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Musculoskeletal and connective tissue disorders
Back Pain
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32.3%
10/31 • Number of events 12 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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General disorders
Nausea
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12.9%
4/31 • Number of events 5 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Infections and infestations
Cold Sore
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3.2%
1/31 • Number of events 4 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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|
Respiratory, thoracic and mediastinal disorders
Tracheal bronchitis
|
3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Renal and urinary disorders
Renal insufficiency (elevated creatinine)
|
3.2%
1/31 • Number of events 1 • Participants were monitored for adverse events (AEs) from the time they signed the consent form until completion of their participation in the study (defined as death, withdrawal of consent, loss to follow up, early termination due to other reasons, or completion of the entire study).
For the purposes of this study, an adverse event is considered any unfavorable and unintended sign (including clinically significant abnormal laboratory findings), symptom, or disease temporally associated with a study, whether or not the adverse event is considered to be related to the drug product under examination.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place