Trial Outcomes & Findings for Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis (NCT NCT03963375)
NCT ID: NCT03963375
Last Updated: 2026-07-28
Results Overview
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
Baseline to Week 5 (5 weeks after first cladribine dose)
Results posted on
2026-07-28
Participant Flow
Potential study participants were identified by the PI and/or collaborators in their clinics or through medical records. A study team member discussed the study and reviewed the consent with prospective participants over the telephone or during a routine office visit. Recruitment began in October of 2019 and ended in June of 2023. Sites were unable to recruit during the height of the COVID pandemic (April \& May, 2020).
All 47 eligible participants were randomized to a study arm.
Participant milestones
| Measure |
Group 1: LP at Baseline and Week 5
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
|
Group 2: LP at Baseline and Week 10
Group 2: LP at Baseline and end of Week 10. Week 10 is the hypothesized "nadir" time for lymphocyte and monocyte levels in CSF
|
Group 3: LP at Baseline and End of Year 1
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
|
Group 4: LP at Baseline and End of Year 2
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
16
|
7
|
|
Overall Study
COMPLETED
|
8
|
15
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: LP at Baseline and Week 5
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
|
Group 2: LP at Baseline and Week 10
Group 2: LP at Baseline and end of Week 10. Week 10 is the hypothesized "nadir" time for lymphocyte and monocyte levels in CSF
|
Group 3: LP at Baseline and End of Year 1
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
|
Group 4: LP at Baseline and End of Year 2
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Defined Withdrawal for low Lymphocyte Count
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Group 1: LP at Baseline and Week 5
n=9 Participants
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
|
Group 2: LP at Baseline and Week 10
n=15 Participants
Group 2: LP at Baseline and end of Week 10. Week 10 is the hypothesized "nadir" time for lymphocyte and monocyte levels in CSF
|
Group 3: LP at Baseline and End of Year 1
n=16 Participants
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
|
Group 4: LP at Baseline and End of Year 2
n=7 Participants
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 15.6 • n=20 Participants
|
44.7 years
STANDARD_DEVIATION 11.6 • n=20 Participants
|
39.3 years
STANDARD_DEVIATION 10.7 • n=40 Participants
|
44.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 12.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
28 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
39 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
45 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Multiple Sclerosis (MS) Type
Relapsing-remitting multiple sclerosis (RRMS)
|
9 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
44 Participants
n=9 Participants
|
|
Multiple Sclerosis (MS) Type
Secondary progressive multiple sclerosis (SPMS)
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Disease (MS) duration
|
8.0 Years
n=20 Participants
|
7.0 Years
n=20 Participants
|
4.0 Years
n=40 Participants
|
8.0 Years
n=5 Participants
|
6.0 Years
n=9 Participants
|
|
Expanded Disability Status Scale (EDSS)
|
2.0 Scores on a scale
n=20 Participants
|
2.5 Scores on a scale
n=20 Participants
|
2.0 Scores on a scale
n=40 Participants
|
4.0 Scores on a scale
n=5 Participants
|
2.0 Scores on a scale
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 5 (5 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 5. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. One (1) participant does not have data at Week 5 - 1 LP not completed (participant withdrew).
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Outcome measures
| Measure |
Week 5
n=8 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells % From Baseline to Week 5
|
0.7 Percentage of CD3+ T cells
Interval -5.8 to 10.5
|
PRIMARY outcome
Timeframe: Baseline to Week 10 (10 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 10. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Week 10 - 1 LP not completed (COVID restrictions), 1 CSF draw insufficient, and 2 data uploads failed.
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Week 10, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 10 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells % From Baseline to Week 10
|
-2.3 Percentage of CD3+ T cells
Interval -8.6 to -0.4
|
PRIMARY outcome
Timeframe: Baseline to Year 1 (45 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 1. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Year 1 - 3 LPs not completed (2 PI withdrew for Leukopenia, 1 refused) and 1 CSF draw was insufficient.
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Year 1, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 1 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Outcome measures
| Measure |
Week 5
n=12 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells % From Baseline to Year 1
|
-7.6 Percentage of CD3+ T cells
Interval -13.4 to -0.5
|
PRIMARY outcome
Timeframe: Baseline to Year 2 (45 weeks after last cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 2. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Three (3) participants do not have data at Year 2 - 2 LPs not completed (1 participant withdrew and 1 refused) and 1 data upload failed.
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Year 2, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 2 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Outcome measures
| Measure |
Week 5
n=4 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells % From Baseline to Year 2
|
0.7 Percentage of CD3+ T cells
Interval -6.2 to 31.1
|
PRIMARY outcome
Timeframe: Baseline to Week 5Population: All participants with an analyzable CSF sample collected at Baseline and Week 5. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. One (1) participant does not have data at Week 5 - 1 LP not completed (participant withdrew).
Change in CSF level of CD3+ T cells absolute numbers from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cells absolute numbers and a negative number indicates decrease in CD3+ T cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=8 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells Absolute Numbers (Cells/mL) From Baseline to Week 5
|
-146.6 Cells/mL
Interval -348.6 to -28.3
|
PRIMARY outcome
Timeframe: Baseline to Week 10 (10 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 10. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Week 10 - 1 LP not completed (COVID restrictions), 1 CSF draw insufficient, and 2 data uploads failed.
Change in CSF level of CD3+ T cells absolute numbers from Baseline to second LP at Week 10, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 10 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cells absolute numbers and a negative number indicates decrease in CD3+ T cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells Absolute Numbers (Cells/mL) From Baseline to Week 10
|
-201.9 Cells/mL
Interval -1775.1 to -106.8
|
PRIMARY outcome
Timeframe: Baseline to Year 1 (45 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 1. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Year 1 - 3 LPs not completed (2 PI withdrew for Leukopenia, 1 refused) and 1 CSF draw was insufficient.
Change in CSF level of CD3+ T cells absolute numbers from Baseline to second LP at Year 1, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 1 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cells absolute numbers and a negative number indicates decrease in CD3+ T cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=12 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells Absolute Numbers (Cells/mL) From Baseline to Year 1
|
-121.9 Cells/mL
Interval -445.5 to -46.9
|
PRIMARY outcome
Timeframe: Baseline to Year 2 (45 weeks after last cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 2. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Three (3) participants do not have data at Year 2 - 2 LPs not completed (1 participant withdrew and 1 refused) and 1 data upload failed.
Change in CSF level of CD3+ T cells absolute numbers from Baseline to second LP at Year 2, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 2 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cells absolute numbers and a negative number indicates decrease in CD3+ T cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=4 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD3+ T Cells Absolute Numbers (Cells/mL) From Baseline to Year 2
|
-0.3 Cells/mL
Interval -1116.2 to 401.4
|
PRIMARY outcome
Timeframe: Baseline to Week 5 (5 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 5. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. One (1) participant does not have data at Week 5 - 1 LP not completed (participant withdrew).
Change in CSF level of CD19+ B lymphocytes from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cell percentage and a negative number indicates decrease in CD19+ B cell percentage.
Outcome measures
| Measure |
Week 5
n=8 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells % From Baseline to Week 5
|
0.0 Percentage of CD19+ B cells
Interval -0.5 to 0.6
|
PRIMARY outcome
Timeframe: Baseline to Week 10 (10 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 10. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Week 10 - 1 LP not completed (COVID restrictions), 1 CSF draw insufficient, and 2 data uploads failed.
Change in CSF level of CD19+ B lymphocytes from Baseline to second LP at Week 10, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 10 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cell percentage and a negative number indicates decrease in CD19+ B cell percentage.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells % From Baseline to Week 10
|
-1.8 Percentage of CD19+ B cells
Interval -2.1 to -0.6
|
PRIMARY outcome
Timeframe: Baseline to Year 1 (45 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 1. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Year 1 - 3 LPs not completed (2 PI withdrew for Leukopenia, 1 refused) and 1 CSF draw was insufficient.
Change in CSF level of CD19+ B lymphocytes from Baseline to second LP at Year 1, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 1 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cell percentage and a negative number indicates decrease in CD19+ B cell percentage.
Outcome measures
| Measure |
Week 5
n=12 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells % From Baseline to Year 1
|
-0.5 Percentage of CD19+ B cells
Interval -1.3 to 0.0
|
PRIMARY outcome
Timeframe: Baseline to Year 2 (45 weeks after last cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 2. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Three (3) participants do not have data at Year 2 - 2 LPs not completed (1 participant withdrew and 1 refused) and 1 data upload failed.
Change in CSF level of CD19+ B lymphocytes from Baseline to second LP at Year 2, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 2 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cell percentage and a negative number indicates decrease in CD19+ B cell percentage.
Outcome measures
| Measure |
Week 5
n=4 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells % From Baseline to Year 2
|
0.4 Percentage of CD19+ B cells
Interval -0.7 to 1.5
|
PRIMARY outcome
Timeframe: Baseline to Week 5 (5 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 5. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. One (1) participant does not have data at Week 5 - 1 LP not completed (participant withdrew).
Change in CSF level of CD19+ B cells absolute numbers from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cells absolute numbers and a negative number indicates decrease in CD19+ B cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=8 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells Absolute Numbers (Cells/mL) From Baseline to Week 5
|
-0.6 Cells/mL
Interval -1.5 to 0.8
|
PRIMARY outcome
Timeframe: Baseline to Week 10 (10 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Week 10. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Week 10 - 1 LP not completed (COVID restrictions), 1 CSF draw insufficient, and 2 data uploads failed.
Change in CSF level of CD19+ B cells absolute numbers from Baseline to second LP at Week 10, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Week 10 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cells absolute numbers and a negative number indicates decrease in CD19+ B cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells Absolute Numbers (Cells/mL) From Baseline to Week 10
|
-11.8 Cells/mL
Interval -62.6 to -5.1
|
PRIMARY outcome
Timeframe: Baseline to Year 1 (45 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 1. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Year 1 - 3 LPs not completed (2 PI withdrew for Leukopenia, 1 refused) and 1 CSF draw was insufficient.
Change in CSF level of CD19+ B cells absolute numbers from Baseline to second LP at Year 1, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 1 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cells absolute numbers and a negative number indicates decrease in CD19+ B cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=12 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells Absolute Numbers (Cells/mL) From Baseline to Year 1
|
-4.3 Cells/mL
Interval -14.2 to 0.4
|
PRIMARY outcome
Timeframe: Baseline to Year 2 (45 weeks after last cladribine dose)Population: All participants with an analyzable CSF sample collected at Baseline and Year 2. To evaluate change of lymphocytes, an LP, CSF draw, flow cytometry, and data upload had to be completed at both baseline and the randomized timepoint. Three (3) participants do not have data at Year 2 - 2 LPs not completed (1 participant withdrew and 1 refused) and 1 data upload failed.
Change in CSF level of CD19+ B cells absolute numbers from Baseline to second LP at Year 2, using quality-controlled flow cytometry and assays. Within-group differences from Baseline to Year 2 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD19+ B cells absolute numbers and a negative number indicates decrease in CD19+ B cells absolute numbers.
Outcome measures
| Measure |
Week 5
n=4 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in CD19+ B Cells Absolute Numbers (Cells/mL) From Baseline to Year 2
|
-0.9 Cells/mL
Interval -30.6 to 8.5
|
PRIMARY outcome
Timeframe: Baseline to Week 5 (5 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at baseline and week 5. To evaluate change in NfL, an LP, CSF draw, sample shipment, and NfL analysis must be completed at both baseline and the randomized timepoint. Two (2) participants do not have data at Week 5 - 1 LP not completed (participant withdrew) and 1 had no additional sample for NfL analysis.
Change in CSF level NfL (measured in pg/mL) from baseline to week 5 using the highly sensitive Neurology 4-Plex D Advantage Plus (N4PD+) single molecule array (SIMOA) technology. A single batch of samples with duplicates were run at the conclusion of the study. Within-group differences from baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in NfL value and a negative number indicates decrease in NfL value.
Outcome measures
| Measure |
Week 5
n=7 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in the Neurofilament Light Chain (NfL) Level From Baseline to Week 5
|
7.0 pg/mL
Interval -310.0 to 260.0
|
PRIMARY outcome
Timeframe: Baseline to Week 10 (10 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at baseline and Week 10. To evaluate change in NfL, an LP, CSF draw, sample shipment, and NfL analysis must be completed at both baseline and the randomized timepoint. Four (4) participants do not have data at Week 10 - 1 LP not completed (COVID restrictions), 1 CSF draw was insufficient, and 2 had no additional samples for NfL analysis.
Change in CSF level NfL (measured in pg/mL) from baseline to Week 10 using the highly sensitive Neurology 4-Plex D Advantage Plus (N4PD+) single molecule array (SIMOA) technology. A single batch of samples with duplicates were run at the conclusion of the study. Within-group differences from baseline to Week 10 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in NfL value and a negative number indicates decrease in NfL value.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in the Neurofilament Light Chain (NfL) Level From Baseline to Week 10
|
-91.0 pg/mL
Interval -512.0 to 9.0
|
PRIMARY outcome
Timeframe: Baseline to Year 1 (45 weeks after first cladribine dose)Population: All participants with an analyzable CSF sample collected at baseline and Year 1. To evaluate change in NfL, an LP, CSF draw, sample shipment, and NfL analysis must be completed at both baseline and the randomized timepoint. Five (5) participants do not have data at Year 1 - 3 LPs were not completed (2 PI withdrew for Leukopenia, 1 refused), 1 CSF draw was insufficient, and 1 had no additional sample for NfL analysis.
Change in CSF level NfL (measured in pg/mL) from baseline to Year 1 using the highly sensitive Neurology 4-Plex D Advantage Plus (N4PD+) single molecule array (SIMOA) technology. A single batch of samples with duplicates were run at the conclusion of the study. Within-group differences from baseline to Year 1 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in NfL value and a negative number indicates decrease in NfL value.
Outcome measures
| Measure |
Week 5
n=11 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in the Neurofilament Light Chain (NfL) Level From Baseline to Year 1
|
-294.0 pg/mL
Interval -991.0 to -129.0
|
PRIMARY outcome
Timeframe: Baseline to Year 2 (45 weeks after last cladribine dose)Population: All participants with an analyzable CSF sample collected at baseline and year 2. To evaluate change in NfL, an LP, CSF draw, sample shipment, and NfL analysis must be completed at both baseline and the randomized timepoint. Two (2) participants do not have data at Year 2 - 2 LPs were not completed (1 participant withdrew and 1 refused).
Change in CSF level NfL (measured in pg/mL) from baseline to year 2 using the highly sensitive Neurology 4-Plex D Advantage Plus (N4PD+) single molecule array (SIMOA) technology. A single batch of samples with duplicates were run at the conclusion of the study. Within-group differences from baseline to year 2 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in NfL value and a negative number indicates decrease in NfL value.
Outcome measures
| Measure |
Week 5
n=5 Participants
Group 1: Participants randomized to LP at Week 5.
|
|---|---|
|
Change in the Neurofilament Light Chain (NfL) Level From Baseline to Year 2
|
-299.0 pg/mL
Interval -609.0 to -4.0
|
Adverse Events
Group 1: LP at Baseline and Week 5
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: LP at Baseline and Week 10
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 3: LP at Baseline and End of Year 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 4: LP at Baseline and End of Year 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: LP at Baseline and Week 5
n=9 participants at risk
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
|
Group 2: LP at Baseline and Week 10
n=15 participants at risk
Group 2: LP at Baseline and end of Week 10. Week 10 is the hypothesized "nadir" time for lymphocyte and monocyte levels in CSF
|
Group 3: LP at Baseline and End of Year 1
n=16 participants at risk
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
|
Group 4: LP at Baseline and End of Year 2
n=7 participants at risk
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
|
|---|---|---|---|---|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Meniscus tear
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
Other adverse events
| Measure |
Group 1: LP at Baseline and Week 5
n=9 participants at risk
Group 1: LP at Baseline and end of Week 5. Week 5 is the optimal time point for assessing cladribine concentrations in CSF
|
Group 2: LP at Baseline and Week 10
n=15 participants at risk
Group 2: LP at Baseline and end of Week 10. Week 10 is the hypothesized "nadir" time for lymphocyte and monocyte levels in CSF
|
Group 3: LP at Baseline and End of Year 1
n=16 participants at risk
Group 3: LP at Baseline and end of Year 1. To assess if cladribine effects on CSF markers are maintained at the end of the first treatment cycle
|
Group 4: LP at Baseline and End of Year 2
n=7 participants at risk
Group 4: LP at Baseline and end of Year 2. To assess if cladribine effects on CSF markers are maintained at the end of the last treatment cycle
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
11.1%
1/9 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Eye disorders
Flashing lights
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
20.0%
3/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
37.5%
6/16 • Number of events 7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Other: Transient lingual papillitis
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
18.8%
3/16 • Number of events 6 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Chills
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Edema limbs
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
20.0%
3/15 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Flu like symptoms
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Rhinovirus
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
18.8%
3/16 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Facial pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Fever
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Sinusitis
|
22.2%
2/9 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Upper respiratory infection
|
88.9%
8/9 • Number of events 13 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
33.3%
5/15 • Number of events 5 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
43.8%
7/16 • Number of events 10 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
20.0%
3/15 • Number of events 5 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Shingles
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 6 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Other: Abrasion
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Injury, poisoning and procedural complications
Other: Laceration
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
18.8%
3/16 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Weight gain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Investigations
Weight loss
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
3/9 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
26.7%
4/15 • Number of events 8 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
25.0%
4/16 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Number of events 4 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
28.6%
2/7 • Number of events 6 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Musculoskeletal and connective tissue disorders
Other: Degenerative disc disease
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other: Basal cell carcinoma
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other: Lipoma
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other: Neoplasm benign
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 10 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
33.3%
5/15 • Number of events 11 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
43.8%
7/16 • Number of events 15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
18.8%
3/16 • Number of events 5 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
12.5%
2/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
18.8%
3/16 • Number of events 3 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Other: Rash
|
11.1%
1/9 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
25.0%
4/16 • Number of events 5 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.2%
1/16 • Number of events 2 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Vascular disorders
Hematoma
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/15 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
|
Vascular disorders
Other: Cold intolerance
|
0.00%
0/9 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/16 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
0.00%
0/7 • Adverse events (AEs) were tracked from enrollment through the end of the Year 2 timepoint.
AEs defined by ClinicalTrials.gov definitions. AEs were assessed at every study visit by patient interview, physical, and blood work. AEs were recorded between visits if participant reported an event. Because group assignments do not have any bearing on when AEs occurred, notes are provided to indicate if the event was deemed related (at least potentially related) to cladribine or LP.
|
Additional Information
Gregory Wu, MD, PhD, FAAN and Study PI
Washington University in St. Louis
Phone: (314) 362-3293
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place