Trial Outcomes & Findings for Oral Cladribine in Early Multiple Sclerosis (MS) (NCT NCT00725985)
NCT ID: NCT00725985
Last Updated: 2021-03-22
Results Overview
CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to Multiple Sclerosis \[MS\]) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.
COMPLETED
PHASE3
617 participants
ITP: Baseline up to Week 96
2021-03-22
Participant Flow
A total of 617 participants were randomized for initial treatment period (ITP) and 616 participants received study drug.
Participant milestones
| Measure |
Cladribine 5.25 mg/kg (ITP)
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg (ITP)
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Placebo (ITP)
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 5.25 mg/kg, Rebif (OLMP)
Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Placebo, Rebif (OLMP)
Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 5.25 mg/kg, Rebif (LTFU)
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif (LTFU)
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif (LTFU)
Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ITP- Treatment Disposition
STARTED
|
205
|
206
|
206
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
Treated
|
204
|
206
|
206
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
COMPLETED
|
104
|
131
|
104
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
NOT COMPLETED
|
101
|
75
|
102
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
STARTED
|
0
|
0
|
0
|
24
|
25
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
COMPLETED
|
0
|
0
|
0
|
6
|
2
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
18
|
23
|
53
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
9
|
17
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
9
|
17
|
0
|
0
|
0
|
|
LTFU (No Cladribine) (48 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
36
|
14
|
|
LTFU (No Cladribine) (48 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTFU (No Cladribine) (48 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
36
|
14
|
Reasons for withdrawal
| Measure |
Cladribine 5.25 mg/kg (ITP)
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg (ITP)
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Placebo (ITP)
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 5.25 mg/kg, Rebif (OLMP)
Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Placebo, Rebif (OLMP)
Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)
Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 5.25 mg/kg, Rebif (LTFU)
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif (LTFU)
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif (LTFU)
Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ITP- Treatment Disposition
Adverse Event
|
20
|
10
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
Randomized but not treated
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
Converted to CDMS
|
30
|
27
|
71
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
ITP- Treatment Disposition
Other
|
50
|
38
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
Adverse Event
|
0
|
0
|
0
|
2
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
Disease progression
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLMP (Up to 96 Weeks)
Other
|
0
|
0
|
0
|
15
|
20
|
44
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
LTFU (Cladribine Treatment) (48 Weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
8
|
16
|
0
|
0
|
0
|
|
LTFU (No Cladribine) (48 Weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
36
|
14
|
Baseline Characteristics
Oral Cladribine in Early Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Cladribine 5.25 mg/kg
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
|
Cladribine 3.5 mg/kg
n=206 Participants
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
|
Placebo
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
|
Age, Customized
Greater than or equal to 30 years
|
111 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Age, Customized
Less than 30 years
|
93 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
400 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Expanded disability status scale (EDSS) score
|
1.6 units on scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.6 units on scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
1.7 units on scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.6 units on scale
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Number of Time Constant 1 (T1) Gadolinium Enhanced (GD+) lesions
|
1.9 lesions
STANDARD_DEVIATION 5.8 • n=5 Participants
|
1.5 lesions
STANDARD_DEVIATION 4.5 • n=7 Participants
|
0.9 lesions
STANDARD_DEVIATION 2.5 • n=5 Participants
|
1.4 lesions
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Number of T2 Lesions
|
29.7 lesions
STANDARD_DEVIATION 29.6 • n=5 Participants
|
26.8 lesions
STANDARD_DEVIATION 28.3 • n=7 Participants
|
26.3 lesions
STANDARD_DEVIATION 27.4 • n=5 Participants
|
27.6 lesions
STANDARD_DEVIATION 28.4 • n=4 Participants
|
|
Time from First Demyelinating Event to Randomization
|
79.35 Days
STANDARD_DEVIATION 17.61 • n=5 Participants
|
78.67 Days
STANDARD_DEVIATION 15.97 • n=7 Participants
|
79.40 Days
STANDARD_DEVIATION 17.94 • n=5 Participants
|
79.14 Days
STANDARD_DEVIATION 17.17 • n=4 Participants
|
|
Monofocal/Multifocal Classification (By Adjudication Committee)
Monofocal
|
108 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
321 Participants
n=4 Participants
|
|
Monofocal/Multifocal Classification (By Adjudication Committee)
Multifocal
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Number of participants Using Steroid Treatment
|
133 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
404 Participants
n=4 Participants
|
|
Number of Participants with Time Constant 1 (T1) Gd-enhanced Lesions
|
90 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: ITP: Baseline up to Week 96Population: The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to Multiple Sclerosis \[MS\]) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS
|
37.8 Cum. % of participants with CDMS
|
14.0 Cum. % of participants with CDMS
|
15.8 Cum. % of participants with CDMS
|
SECONDARY outcome
Timeframe: ITP: Baseline up to Week 96Population: The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. percentage (%) of participants with McDonald MS over time.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS
|
87.14 Cum. % of participants with McDonald MS
|
56.05 Cum. % of participants with McDonald MS
|
51.36 Cum. % of participants with McDonald MS
|
SECONDARY outcome
Timeframe: ITP: Baseline up to Week 96Population: The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=196 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=202 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=203 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan
CUA lesions
|
2.13 Lesions
Standard Deviation 2.87
|
0.65 Lesions
Standard Deviation 1.80
|
1.20 Lesions
Standard Deviation 5.79
|
|
ITP: Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan
New or persisting T1 Gd+ lesions
|
0.97 Lesions
Standard Deviation 1.62
|
0.29 Lesions
Standard Deviation 0.97
|
0.61 Lesions
Standard Deviation 5.33
|
|
ITP: Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan
New or enlarging T2 lesions
|
1.17 Lesions
Standard Deviation 1.87
|
0.40 Lesions
Standard Deviation 1.12
|
0.62 Lesions
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: OLMP: Day 1, 90, 180, 270, 360, 450, 540, 630, 720 and 810Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif). Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in Multiple Sclerosis (MS). Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. Probability of disability progression at different time points was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 1
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 90
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
0.0000 Probability of Disability Progression
Interval 0.0 to 0.0
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 360
|
0.0527 Probability of Disability Progression
Interval -0.0054 to 0.1108
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 450
|
0.0764 Probability of Disability Progression
Interval 0.0035 to 0.1492
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 540
|
0.1094 Probability of Disability Progression
Interval 0.0147 to 0.2041
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 720
|
0.1094 Probability of Disability Progression
Interval 0.0147 to 0.2041
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 180
|
0.0527 Probability of Disability Progression
Interval -0.0054 to 0.1108
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 270
|
0.0527 Probability of Disability Progression
Interval -0.0054 to 0.1108
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
|
OLMP: Time to 3 Month Confirmed Expanded Disability Status Scale (EDSS) Progression From Randomization Represented by Kaplan-Meier Estimates of Probability of Disability Progression
Day 630
|
0.1094 Probability of Disability Progression
Interval 0.0147 to 0.2041
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
0.0417 Probability of Disability Progression
Interval -0.0383 to 0.1216
|
SECONDARY outcome
Timeframe: Time from Randomization up to 1217 daysPopulation: LTFU analysis set (No Treatment at LTFU Entry) consists of all participants who completed the 96-week ITP and entered the LTFU for safety follow-up and did not receive study treatment upon entry to the LTFU. Here "Number of Participants analyzed" signifies those participants who have been converted to CDMS.
The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI.
Outcome measures
| Measure |
Placebo (ITP)
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=1 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Time to Conversion to Multiple Sclerosis (MS) According to the 2005 McDonald Criteria
|
—
|
—
|
773 Days
|
SECONDARY outcome
Timeframe: Time from Randomization up to 1217 daysPopulation: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number of Participants Analyzed" signifies those participants who have been converted to CDMS.
CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months.
Outcome measures
| Measure |
Placebo (ITP)
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=1 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) According to Poser Criteria
|
—
|
—
|
773 Days
|
SECONDARY outcome
Timeframe: Time from Randomization up to 1217 daysPopulation: LTFU analysis set (Treated at LTFU Entry) analysis set consisted of all participants who converted to McDonald MS (2005) during the ITP, completed ITP 96-weeks and entered the LTFU. Here "Number of Participants analyzed" signifies those participants who have been converted to CDMS.
CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months.
Outcome measures
| Measure |
Placebo (ITP)
n=1 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) According to Poser Criteria
|
767 Days
|
—
|
—
|
SECONDARY outcome
Timeframe: ITP: Baseline up to week 96Population: ITT analysis set included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months. The percentage of participants who converted to CDMS are reported here.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) as Per Poser Criteria
|
56.3 Percentage of participants
|
23.1 Percentage of participants
|
28.8 Percentage of participants
|
SECONDARY outcome
Timeframe: ITP: Baseline up to week 96Population: Intent-to-Treat analysis set included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
Percentage of participants converting to mcDonald multiple sclerosis (2005) were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Percentage of Participants Converting to McDonald Multiple Sclerosis (MS) (2005)
|
91.8 Percentage of participants
|
71.6 Percentage of participants
|
70.7 Percentage of participants
|
SECONDARY outcome
Timeframe: ITP: Week 13, 24, 36, 48, 60, 72, 84 and 96Population: The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or persisting Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 13
|
1.00 Lesions
Standard Deviation 1.98
|
0.37 Lesions
Standard Deviation 1.52
|
0.86 Lesions
Standard Deviation 5.60
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 24
|
0.92 Lesions
Standard Deviation 1.69
|
0.13 Lesions
Standard Deviation 0.51
|
0.03 Lesions
Standard Deviation 0.20
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 36
|
0.74 Lesions
Standard Deviation 1.28
|
0.14 Lesions
Standard Deviation 0.44
|
0.08 Lesions
Standard Deviation 0.38
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 48
|
0.87 Lesions
Standard Deviation 1.81
|
0.27 Lesions
Standard Deviation 0.92
|
0.02 Lesions
Standard Deviation 0.13
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 60
|
0.74 Lesions
Standard Deviation 1.61
|
0.22 Lesions
Standard Deviation 0.94
|
0.10 Lesions
Standard Deviation 0.84
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 72
|
0.90 Lesions
Standard Deviation 1.88
|
0.16 Lesions
Standard Deviation 0.81
|
0.05 Lesions
Standard Deviation 0.53
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 84
|
0.60 Lesions
Standard Deviation 1.20
|
0.32 Lesions
Standard Deviation 2.62
|
0.02 Lesions
Standard Deviation 0.13
|
|
ITP: Number of New or Persisting Gd-enhanced Lesions
Week 96
|
0.64 Lesions
Standard Deviation 1.25
|
0.18 Lesions
Standard Deviation 0.84
|
0.07 Lesions
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 24, 48, 72 and 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study drug, converted to CDMS in ITP period, entered OLMP and received at least 1 dose of OLMP study drug. Here "Number of participants analyzed" = participants who were evaluable for this outcome measure and "Number analyzed" = who were evaluable at specified time point.
Number of new or persisting Gd-Enhanced lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=59 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=24 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Number of New or Persisting Gd-enhanced Lesions
Baseline
|
1.27 Lesions
Standard Deviation 2.58
|
0.88 Lesions
Standard Deviation 1.80
|
1.38 Lesions
Standard Deviation 5.52
|
|
OLMP: Number of New or Persisting Gd-enhanced Lesions
Week 24
|
0.11 Lesions
Standard Deviation 0.56
|
0.05 Lesions
Standard Deviation 0.21
|
0.17 Lesions
Standard Deviation 0.48
|
|
OLMP: Number of New or Persisting Gd-enhanced Lesions
Week 48
|
0.20 Lesions
Standard Deviation 0.50
|
0.00 Lesions
Standard Deviation 0.00
|
0.07 Lesions
Standard Deviation 0.24
|
|
OLMP: Number of New or Persisting Gd-enhanced Lesions
Week 72
|
0.33 Lesions
Standard Deviation 1.18
|
0.13 Lesions
Standard Deviation 0.35
|
1.50 Lesions
Standard Deviation 3.28
|
|
OLMP: Number of New or Persisting Gd-enhanced Lesions
Week 96
|
0.07 Lesions
Standard Deviation 0.26
|
0.00 Lesions
Standard Deviation 0.00
|
1.58 Lesions
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24 and 36Population: LTFU analysis set (Treated at LTFU Entry) analysis set consisted of all participants who converted to McDonald MS (2005) during the ITP, completed ITP 96-weeks and entered the LTFU. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or persisting Gd-Enhanced lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Baseline
|
0.71 Lesions
Standard Deviation 1.16
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 13
|
0.13 Lesions
Standard Deviation 0.34
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 24
|
0.18 Lesions
Standard Deviation 0.40
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 36
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24, 36 and 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or persisting Gd-Enhanced lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Baseline
|
0.14 Lesions
Standard Deviation 0.36
|
0.06 Lesions
Standard Deviation 0.23
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 13
|
0.09 Lesions
Standard Deviation 0.30
|
0.07 Lesions
Standard Deviation 0.23
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 24
|
0.20 Lesions
Standard Deviation 0.45
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 36
|
0.17 Lesions
Standard Deviation 0.29
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Persisting Gd-enhanced Lesions
Week 48
|
—
|
—
|
0.00 Lesions
|
SECONDARY outcome
Timeframe: ITP: Week 13, 24, 36, 48, 60, 72, 84 and 96Population: The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or enlarging T2 lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of New or Enlarging T2 Lesions
Week 96
|
0.38 Lesions
Standard Deviation 0.85
|
0.10 Lesions
Standard Deviation 0.59
|
0.04 Lesions
Standard Deviation 0.25
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 13
|
1.43 Lesions
Standard Deviation 2.56
|
1.25 Lesions
Standard Deviation 3.33
|
1.56 Lesions
Standard Deviation 3.52
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 24
|
1.01 Lesions
Standard Deviation 1.70
|
0.20 Lesions
Standard Deviation 0.66
|
0.24 Lesions
Standard Deviation 0.95
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 36
|
1.14 Lesions
Standard Deviation 1.87
|
0.12 Lesions
Standard Deviation 0.42
|
0.09 Lesions
Standard Deviation 0.40
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 48
|
1.04 Lesions
Standard Deviation 1.54
|
0.32 Lesions
Standard Deviation 2.52
|
0.07 Lesions
Standard Deviation 0.50
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 60
|
0.71 Lesions
Standard Deviation 1.57
|
0.25 Lesions
Standard Deviation 1.09
|
0.13 Lesions
Standard Deviation 0.63
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 72
|
0.83 Lesions
Standard Deviation 1.77
|
0.10 Lesions
Standard Deviation 0.34
|
0.03 Lesions
Standard Deviation 0.22
|
|
ITP: Number of New or Enlarging T2 Lesions
Week 84
|
0.61 Lesions
Standard Deviation 1.31
|
0.28 Lesions
Standard Deviation 2.03
|
0.09 Lesions
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 24, 48, 72 and 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study drug, converted to CDMS in ITP period, entered OLMP and received at least 1 dose of OLMP study drug. Here "Number of participants analyzed" = participants who were evaluable for this outcome measure and "Number analyzed" = who were evaluable at specified time point.
Number of new or enlarging T2 lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=24 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Number of New or Enlarging T2 Lesions
Baseline
|
2.13 Lesions
Standard Deviation 7.29
|
1.54 Lesions
Standard Deviation 6.72
|
0.29 Lesions
Standard Deviation 0.75
|
|
OLMP: Number of New or Enlarging T2 Lesions
Week 96
|
0.47 Lesions
Standard Deviation 1.06
|
0.67 Lesions
Standard Deviation 1.15
|
2.00 Lesions
Standard Deviation 3.52
|
|
OLMP: Number of New or Enlarging T2 Lesions
Week 24
|
0.68 Lesions
Standard Deviation 1.10
|
0.43 Lesions
Standard Deviation 1.35
|
0.26 Lesions
Standard Deviation 0.69
|
|
OLMP: Number of New or Enlarging T2 Lesions
Week 48
|
0.41 Lesions
Standard Deviation 0.71
|
0.38 Lesions
Standard Deviation 1.09
|
0.32 Lesions
Standard Deviation 0.65
|
|
OLMP: Number of New or Enlarging T2 Lesions
Week 72
|
0.97 Lesions
Standard Deviation 1.69
|
0.25 Lesions
Standard Deviation 0.46
|
0.95 Lesions
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24 and 36Population: LTFU analysis set (Treated at LTFU Entry) analysis set consisted of all participants who converted to McDonald MS (2005) during the ITP, completed ITP 96-weeks and entered the LTFU. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or enlarging T2 Lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Enlarging T2 Lesions
Baseline
|
0.71 Lesions
Standard Deviation 1.53
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 13
|
2.06 Lesions
Standard Deviation 4.25
|
0.25 Lesions
Standard Deviation 0.46
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 24
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 36
|
0.10 Lesions
Standard Deviation 0.32
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24, 36 and 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of new or enlarging T2 lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Enlarging T2 Lesions
Baseline
|
0.07 Lesions
Standard Deviation 0.27
|
0.03 Lesions
Standard Deviation 0.17
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 13
|
0.18 Lesions
Standard Deviation 0.40
|
0.04 Lesions
Standard Deviation 0.21
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 24
|
0.00 Lesions
Standard Deviation 0.00
|
0.13 Lesions
Standard Deviation 0.35
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 36
|
0.33 Lesions
Standard Deviation 0.58
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of New or Enlarging T2 Lesions
Week 48
|
—
|
—
|
0.00 Lesions
|
SECONDARY outcome
Timeframe: ITP: Week 13, 24, 36, 48, 60, 72, 84 and 96Population: ITT population included all randomized participants who received at least 1 dose of ITP study medication. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at specified time point.
Number of CUA lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=192 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=189 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=189 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 13
|
2.41 Lesions
Standard Deviation 3.89
|
1.56 Lesions
Standard Deviation 4.04
|
2.37 Lesions
Standard Deviation 6.87
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 72
|
1.66 Lesions
Standard Deviation 3.05
|
0.22 Lesions
Standard Deviation 1.03
|
0.08 Lesions
Standard Deviation 0.72
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 84
|
1.14 Lesions
Standard Deviation 1.95
|
0.55 Lesions
Standard Deviation 4.52
|
0.11 Lesions
Standard Deviation 0.51
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 96
|
0.99 Lesions
Standard Deviation 1.89
|
0.23 Lesions
Standard Deviation 1.39
|
0.11 Lesions
Standard Deviation 0.60
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 24
|
1.91 Lesions
Standard Deviation 2.93
|
0.29 Lesions
Standard Deviation 0.89
|
0.26 Lesions
Standard Deviation 1.03
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 36
|
1.84 Lesions
Standard Deviation 2.64
|
0.25 Lesions
Standard Deviation 0.70
|
0.16 Lesions
Standard Deviation 0.71
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 48
|
1.89 Lesions
Standard Deviation 2.78
|
0.56 Lesions
Standard Deviation 3.05
|
0.09 Lesions
Standard Deviation 0.59
|
|
ITP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 60
|
1.44 Lesions
Standard Deviation 2.70
|
0.42 Lesions
Standard Deviation 1.87
|
0.23 Lesions
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 24, 48, 72 and 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study drug, converted to CDMS in ITP period, entered OLMP and received at least 1 dose of OLMP study drug. Here "Number of participants analyzed" = participants who were evaluable for this outcome measure and "Number analyzed" = who were evaluable at specified time point.
Number of combined unique active (CUA) lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=24 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 48
|
0.61 Lesions
Standard Deviation 1.02
|
0.38 Lesions
Standard Deviation 1.09
|
0.39 Lesions
Standard Deviation 0.81
|
|
OLMP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 72
|
1.30 Lesions
Standard Deviation 2.71
|
0.38 Lesions
Standard Deviation 0.74
|
2.45 Lesions
Standard Deviation 5.01
|
|
OLMP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 96
|
0.53 Lesions
Standard Deviation 1.25
|
0.67 Lesions
Standard Deviation 1.15
|
3.33 Lesions
Standard Deviation 6.03
|
|
OLMP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Baseline
|
3.23 Lesions
Standard Deviation 8.07
|
2.17 Lesions
Standard Deviation 7.72
|
0.63 Lesions
Standard Deviation 1.17
|
|
OLMP: Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 24
|
0.79 Lesions
Standard Deviation 1.33
|
0.48 Lesions
Standard Deviation 1.40
|
0.42 Lesions
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24 and 36Population: LTFU analysis set (Treated at LTFU Entry) analysis set consisted of all participants who converted to McDonald MS (2005) during the ITP, completed ITP 96-weeks and entered the LTFU. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of CUA MRI lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Baseline
|
1.24 Lesions
Standard Deviation 2.49
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 24
|
0.18 Lesions
Standard Deviation 0.40
|
0.25 Lesions
Standard Deviation 0.46
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 13
|
2.19 Lesions
Standard Deviation 4.46
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 36
|
0.10 Lesions
Standard Deviation 0.32
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24, 36 and 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of CUA lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Baseline
|
0.14 Lesions
Standard Deviation 0.36
|
0.03 Lesions
Standard Deviation 0.17
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 13
|
0.18 Lesions
Standard Deviation 0.40
|
0.04 Lesions
Standard Deviation 0.21
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 36
|
0.33 Lesions
Standard Deviation 0.58
|
0.00 Lesions
Standard Deviation 0.00
|
0.00 Lesions
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 48
|
—
|
—
|
0.00 Lesions
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions
Week 24
|
0.00 Lesions
Standard Deviation 0.00
|
0.13 Lesions
Standard Deviation 0.35
|
0.00 Lesions
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: ITP: Baseline, Week 96Population: ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" = participants evaluable at specified timepoint.
Change in volume of T1 Gd-Enhanced lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=197 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=203 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=203 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Change From Baseline in Volume of T1 Gd-Enhanced Lesions
|
48.63 cubic millimeters (mm^3)
Standard Deviation 239.03
|
-126.64 cubic millimeters (mm^3)
Standard Deviation 399.39
|
-73.97 cubic millimeters (mm^3)
Standard Deviation 204.80
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 24, 48, 72 and 96Population: OLMP Analysis Set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" = participants evaluable at specified timepoint.
Volume of T1 Gd-Enhanced lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=24 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Baseline
|
136.61 mm^3
Standard Deviation 344.31
|
113.64 mm^3
Standard Deviation 248.74
|
91.06 mm^3
Standard Deviation 368.98
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 48
|
39.00 mm^3
Standard Deviation 188.80
|
0.00 mm^3
Standard Deviation 0.00
|
5.22 mm^3
Standard Deviation 19.75
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 48
|
-116.06 mm^3
Standard Deviation 429.90
|
-146.62 mm^3
Standard Deviation 298.86
|
-106.82 mm^3
Standard Deviation 415.70
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 72
|
-192.24 mm^3
Standard Deviation 439.11
|
-155.91 mm^3
Standard Deviation 341.97
|
26.00 mm^3
Standard Deviation 600.82
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 96
|
-247.76 mm^3
Standard Deviation 593.34
|
-391.93 mm^3
Standard Deviation 523.92
|
275.83 mm^3
Standard Deviation 360.07
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 24
|
9.14 mm^3
Standard Deviation 55.62
|
3.48 mm^3
Standard Deviation 16.70
|
7.71 mm^3
Standard Deviation 26.35
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 72
|
25.85 mm^3
Standard Deviation 96.18
|
56.86 mm^3
Standard Deviation 160.83
|
219.52 mm^3
Standard Deviation 377.85
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 96
|
22.51 mm^3
Standard Deviation 87.17
|
0.00 mm^3
Standard Deviation 0.00
|
330.20 mm^3
Standard Deviation 442.02
|
|
OLMP: Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 24
|
-134.67 mm^3
Standard Deviation 343.19
|
-120.04 mm^3
Standard Deviation 250.42
|
-87.30 mm^3
Standard Deviation 379.50
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24 and 36Population: LTFU analysis set (Treated at LTFU Entry) was used. Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Volume of T1 Gd-Enhanced lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Baseline
|
79.43 mm^3
Standard Deviation 143.64
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 13
|
20.56 mm^3
Standard Deviation 70.96
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 24
|
25.23 mm^3
Standard Deviation 66.24
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 36
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 13
|
-63.83 mm^3
Standard Deviation 147.43
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 24
|
-32.25 mm^3
Standard Deviation 113.96
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 36
|
-58.93 mm^3
Standard Deviation 85.19
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 13, 24, 36 and 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Volume of T1 Gd-Enhanced lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 36
|
57.22 mm^3
Standard Deviation 99.10
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 48
|
—
|
—
|
0.00 mm^3
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Baseline
|
27.79 mm^3
Standard Deviation 76.02
|
4.45 mm^3
Standard Deviation 21.25
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 13
|
17.43 mm^3
Standard Deviation 57.80
|
7.34 mm^3
Standard Deviation 27.76
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Week 24
|
57.22 mm^3
Standard Deviation 127.95
|
0.00 mm^3
Standard Deviation 0.00
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 13
|
-17.95 mm^3
Standard Deviation 41.38
|
0.38 mm^3
Standard Deviation 1.32
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 24
|
-20.60 mm^3
Standard Deviation 57.89
|
-2.48 mm^3
Standard Deviation 9.60
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 36
|
-31.48 mm^3
Standard Deviation 54.53
|
-5.31 mm^3
Standard Deviation 14.06
|
0.00 mm^3
Standard Deviation 0.00
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T1 Gd-Enhanced Lesions and Changes From Baseline in Volume of T1 Gd-Enhanced Lesions
Change at Week 48
|
—
|
—
|
0.00 mm^3
|
SECONDARY outcome
Timeframe: ITP: Baseline, Week 48 and 96Population: ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Change in volume of T2 lesions from baseline was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Changes From Baseline in Volume of T2 Lesions
Baseline
|
3436.69 mm^3
Standard Deviation 4613.43
|
3435.22 mm^3
Standard Deviation 5184.12
|
3825.73 mm^3
Standard Deviation 5093.52
|
|
ITP: Changes From Baseline in Volume of T2 Lesions
Change at Week 48
|
-29.57 mm^3
Standard Deviation 2581.44
|
-828.97 mm^3
Standard Deviation 3513.04
|
-654.20 mm^3
Standard Deviation 2061.85
|
|
ITP: Changes From Baseline in Volume of T2 Lesions
Change at Week 96
|
-886.39 mm^3
Standard Deviation 2955.44
|
-1605.63 mm^3
Standard Deviation 2889.61
|
-1237.44 mm^3
Standard Deviation 2718.76
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 48 and 96Population: OLMP Analysis Set was used. Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Volume of T2 lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Baseline
|
1019.30 mm^3
Standard Deviation 2872.03
|
630.70 mm^3
Standard Deviation 1707.24
|
398.88 mm^3
Standard Deviation 1102.27
|
|
OLMP: Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Week 48
|
508.97 mm^3
Standard Deviation 1159.97
|
458.13 mm^3
Standard Deviation 984.12
|
767.66 mm^3
Standard Deviation 1875.86
|
|
OLMP: Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Week 96
|
647.17 mm^3
Standard Deviation 1345.62
|
0.00 mm^3
Standard Deviation 0.00
|
2606.15 mm^3
Standard Deviation 5542.81
|
|
OLMP: Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Change at Week 48
|
-77.67 mm^3
Standard Deviation 1760.20
|
-20.20 mm^3
Standard Deviation 2025.21
|
523.27 mm^3
Standard Deviation 2065.54
|
|
OLMP: Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Change at Week 96
|
255.39 mm^3
Standard Deviation 1352.80
|
0.00 mm^3
Standard Deviation 0.00
|
2245.18 mm^3
Standard Deviation 5810.53
|
SECONDARY outcome
Timeframe: LTFU: Baseline (Day 1)Population: LTFU analysis set (Treated at LTFU Entry) was used.
Volume of T2 lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Mean Volume of T2 Lesions
|
702.30 mm^3
Standard Deviation 1254.66
|
587.79 mm^3
Standard Deviation 1491.20
|
1217.53 mm^3
Standard Deviation 1991.21
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" = participants evaluable at specified timepoint.
Volume of T2 lesions was measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Change at Week 48
|
—
|
—
|
-969.90 mm^3
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Baseline
|
1407.75 mm^3
Standard Deviation 1890.94
|
962.26 mm^3
Standard Deviation 1026.99
|
1402.08 mm^3
Standard Deviation 1799.96
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Mean Volume of T2 Lesions and Changes From Baseline in Volume of T2 Lesions
Week 48
|
—
|
—
|
0.00 mm^3
|
SECONDARY outcome
Timeframe: ITP: Baseline, Week 48 and 96Population: ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Number of T1 Hypointense lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of T1 Hypointense Lesions
Baseline
|
7.0 Lesions
Standard Deviation 8.6
|
7.3 Lesions
Standard Deviation 12.2
|
8.0 Lesions
Standard Deviation 11.7
|
|
ITP: Number of T1 Hypointense Lesions
Week 48
|
7.07 Lesions
Standard Deviation 8.75
|
6.95 Lesions
Standard Deviation 12.86
|
8.39 Lesions
Standard Deviation 12.60
|
|
ITP: Number of T1 Hypointense Lesions
Week 96
|
5.06 Lesions
Standard Deviation 6.82
|
3.82 Lesions
Standard Deviation 6.89
|
5.35 Lesions
Standard Deviation 8.14
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 48 and 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif). Here "Number analyzed" = participants evaluable at specified timepoint for this outcome measure.
Number of T1 Hypointense lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Number of T1 Hypointense Lesions
Baseline
|
1.45 Lesions
Standard Deviation 3.53
|
2.32 Lesions
Standard Deviation 9.52
|
0.92 Lesions
Standard Deviation 2.22
|
|
OLMP: Number of T1 Hypointense Lesions
Week 48
|
0.74 Lesions
Standard Deviation 1.83
|
1.00 Lesions
Standard Deviation 2.85
|
3.79 Lesions
Standard Deviation 8.32
|
|
OLMP: Number of T1 Hypointense Lesions
Week 96
|
1.47 Lesions
Standard Deviation 2.80
|
0.00 Lesions
Standard Deviation 0.00
|
0.50 Lesions
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: LTFU: Baseline (Day 1)Population: LTFU analysis set (Treated at LTFU Entry) analysis set consisted of all participants who converted to McDonald MS (2005) during the ITP, completed ITP 96-weeks and entered the LTFU.
Number of T1 Hypointense lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of T1 Hypointense Lesions
|
2.24 Lesions
Standard Deviation 5.01
|
1.22 Lesions
Standard Deviation 3.31
|
4.44 Lesions
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: LTFU: Baseline, Week 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used. Here "Number analyzed" signifies those participants who were evaluable at specified time point for this outcome measure.
Number of T1 Hypointense lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of T1 Hypointense Lesions
Baseline
|
2.93 Lesions
Standard Deviation 4.46
|
3.53 Lesions
Standard Deviation 5.78
|
5.74 Lesions
Standard Deviation 8.21
|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of T1 Hypointense Lesions
Week 48
|
—
|
—
|
4.50 Lesions
|
SECONDARY outcome
Timeframe: ITP: Baseline up to Week 96Population: The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
T1 Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or persisting T1 Gd-enhanced lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Percentage of Participants With no New or Persisting T1 Gd-Enhanced Lesions
|
21.6 Percentage of Participants
|
57.1 Percentage of Participants
|
67.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: OLMP: Baseline up to Week 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif).
T1 Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or persisting T1 Gd-enhanced lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Percentage of Participants With no New or Persisting T1 Gd-Enhanced Lesions
|
35.3 Percentage of participants
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: LTFU: Baseline up to Week 48Population: LTFU analysis set (Treated at LTFU Entry) was used.
T1 Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or persisting T1 Gd-enhanced lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Percentage of Participants With no New or Persisting T1 Gd-Enhanced Lesions
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used.
T1 Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or persisting T1 Gd-enhanced lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Percentage of Participants With no New or Persisting T1 Gd-Enhanced Lesions
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: ITP: Baseline up to Week 96Population: The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).
T2 lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or enlarging T2 lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Percentage of Participants With no New or Enlarging T2 Lesions
|
19.0 Percentage of Participants
|
35.1 Percentage of Participants
|
32.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: OLMP: Baseline up to 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif).
T2 Gd-enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no new or enlarging T2 Lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Percentage of Participants With no New or Enlarging T2 Lesions
|
13.5 Percentage of participants
|
16.7 Percentage of participants
|
18.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: LTFU analysis set (Treated at LTFU Entry) was used.
Enlarging T2 Lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no New or Enlarging T2 Lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Percentage of Participants With no New or Enlarging T2 Lesions
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: LTFU: Baseline up to Week 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used.
Enlarging T2 lesions were measured by using magnetic resonance imaging (MRI) scans. Percentage of participants with no New or Enlarging T2 lesions were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Percentage of Participants With no New or Enlarging T2 Lesions
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: ITP: Baseline, Week 48 and 96Population: The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo). Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" = participants evaluable at specified timepoint.
Brain volume was measured by using magnetic resonance imaging (MRI) scans. Percent change from baseline in brain volume at Week 48 and 96 was reported.
Outcome measures
| Measure |
Placebo (ITP)
n=135 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=163 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=155 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Percent Change From Baseline in Brain Volume
Week 48
|
-0.33 Percent change
Standard Deviation 0.76
|
-0.48 Percent change
Standard Deviation 0.69
|
-0.47 Percent change
Standard Deviation 0.63
|
|
ITP: Percent Change From Baseline in Brain Volume
Week 96
|
-0.75 Percent change
Standard Deviation 0.65
|
-0.72 Percent change
Standard Deviation 0.73
|
-0.59 Percent change
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: OLMP: Baseline, Week 48 and 96Population: OLMP Analysis Set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" = participants evaluable at specified timepoint.
Brain volume was measured by using magnetic resonance imaging (MRI) scans. Percent change from baseline in brain volume at Week 48 and 96 was reported.
Outcome measures
| Measure |
Placebo (ITP)
n=11 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=4 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=5 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Percent Change From Baseline in Brain Volume
Week 48
|
-0.56 Percent change
Standard Deviation 1.11
|
-1.60 Percent change
Standard Deviation 1.40
|
-0.41 Percent change
Standard Deviation 0.98
|
|
OLMP: Percent Change From Baseline in Brain Volume
Week 96
|
-1.31 Percent change
Standard Deviation 0.76
|
—
|
0.06 Percent change
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Baseline up to Week 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif).
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Number of Relapses
|
0.55 Relapses
Standard Deviation 1.00
|
0.16 Relapses
Standard Deviation 0.37
|
0.33 Relapses
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: LTFU analysis set (Treated at LTFU Entry) was used.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Outcome measures
| Measure |
Placebo (ITP)
n=17 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=9 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=9 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [Treated at LTFU Entry]): Number of Relapses
|
0.06 Relapses
Standard Deviation 0.24
|
0.00 Relapses
Standard Deviation 0.00
|
0.00 Relapses
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: LTFU analysis set (No Treatment at LTFU Entry) was used.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Outcome measures
| Measure |
Placebo (ITP)
n=14 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=36 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=34 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
LTFU (LTFU Analysis Set [No Treatment at LTFU Entry]): Number of Relapses
|
0.00 Relapses
Standard Deviation 0.00
|
0.03 Relapses
Standard Deviation 0.17
|
0.03 Relapses
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline up to Week 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif).
The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25. Where, Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Outcome measures
| Measure |
Placebo (ITP)
n=60 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=24 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Annualized Relapse Rate
|
0.42 relapses per year
Interval 0.28 to 0.56
|
0.14 relapses per year
Interval 0.0 to 0.27
|
0.24 relapses per year
Interval 0.07 to 0.4
|
SECONDARY outcome
Timeframe: Baseline up to Week 96Population: OLMP Analysis Set included all participants who received at least 1 dose of study medication, converted to CDMS in the ITP period, entered the OLMP and received at least 1 dose of OLMP study drug (Rebif). Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of relapse-free participants were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=26 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=5 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=10 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
OLMP: Percentage of Relapse-Free Participants
|
30.8 Percentage of participants
|
20.0 Percentage of participants
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: ITP: Baseline up to Week 96Population: Safety analysis set included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. Number of Participants with TEAEs and serious TEAEs were reported.
Outcome measures
| Measure |
Placebo (ITP)
n=206 Participants
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=206 Participants
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg (ITP)
n=204 Participants
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
|---|---|---|---|
|
ITP: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
162 Participants
|
168 Participants
|
165 Participants
|
|
ITP: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
22 Participants
|
23 Participants
|
12 Participants
|
Adverse Events
Cladribine 5.25 mg/kg (ITP)
Cladribine 3.5 mg/kg (ITP)
Placebo (ITP)
Cladribine 5.25 mg/kg, Rebif (OLMP)
Cladribine 3.5 mg/kg, Rebif (OLMP)
Placebo, Rebif (OLMP)
Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)
Cladribine 5.25 mg/kg, Rebif (LTFU)
Cladribine 3.5 mg/kg, Rebif (LTFU)
Placebo, Rebif (LTFU)
Serious adverse events
| Measure |
Cladribine 5.25 mg/kg (ITP)
n=204 participants at risk
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg (ITP)
n=206 participants at risk
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Placebo (ITP)
n=206 participants at risk
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 5.25 mg/kg, Rebif (OLMP)
n=24 participants at risk
Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 participants at risk
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Placebo, Rebif (OLMP)
n=60 participants at risk
Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=9 participants at risk
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=9 participants at risk
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=16 participants at risk
Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 5.25 mg/kg, Rebif (LTFU)
n=34 participants at risk
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif (LTFU)
n=36 participants at risk
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif (LTFU)
n=14 participants at risk
Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
3/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.4%
7/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.9%
4/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Injection site necrosis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Blood amylase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.97%
2/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Lipase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.97%
2/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Blood potassium increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Platelet count decreased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.5%
3/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.97%
2/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm benign
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.97%
2/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Herpes zoster
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mass
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Cardiac disorders
Myocarditis
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Vascular disorders
Hypertension
|
0.49%
1/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
2.8%
1/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.98%
2/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
Other adverse events
| Measure |
Cladribine 5.25 mg/kg (ITP)
n=204 participants at risk
Cladribine tablets administered as cumulative dose of 0.875 milligrams per kilograms (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
|
Cladribine 3.5 mg/kg (ITP)
n=206 participants at risk
Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Placebo (ITP)
n=206 participants at risk
Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
|
Cladribine 5.25 mg/kg, Rebif (OLMP)
n=24 participants at risk
Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 3.5 mg/kg, Rebif (OLMP)
n=25 participants at risk
Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Placebo, Rebif (OLMP)
n=60 participants at risk
Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
|
Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=9 participants at risk
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=9 participants at risk
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)
n=16 participants at risk
Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 5.25 mg/kg, Rebif (LTFU)
n=34 participants at risk
Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Cladribine 3.5 mg/kg, Rebif (LTFU)
n=36 participants at risk
Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
Placebo, Rebif (LTFU)
n=14 participants at risk
Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
23.0%
47/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
12.1%
25/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.3%
2/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
23/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.7%
24/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
9.2%
19/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
11/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.8%
16/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.3%
13/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
10/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.3%
15/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.9%
4/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
7/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.4%
9/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.8%
12/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
6/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.8%
14/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.9%
8/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Fatigue
|
7.4%
15/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.3%
15/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
9.2%
19/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
12.5%
3/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Nasopharyngitis
|
17.6%
36/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
17.0%
35/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
18.4%
38/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
5/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
23/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
10.2%
21/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
17/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
12.5%
2/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Influenza
|
6.9%
14/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
10.2%
21/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.3%
13/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
10.0%
6/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Pharyngitis
|
5.9%
12/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.9%
10/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.8%
12/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
36.0%
9/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
14/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
17/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.3%
13/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
10/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.3%
13/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.3%
13/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.0%
2/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.3%
2/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
10/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.3%
11/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.4%
9/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Headache
|
28.4%
58/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
31.1%
64/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
27.7%
57/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
20.8%
5/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
32.0%
8/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
16.7%
10/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
18.8%
3/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.9%
2/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Dizziness
|
5.9%
12/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.8%
16/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
9.2%
19/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Paraesthesia
|
4.4%
9/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.3%
11/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.9%
10/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Psychiatric disorders
Insomnia
|
2.5%
5/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.4%
9/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.8%
12/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.7%
4/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.8%
16/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.9%
10/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.9%
10/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
10/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.9%
8/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.3%
11/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.0%
1/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.0%
2/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.3%
2/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.0%
2/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Eye disorders
Eye pain
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
1.7%
1/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.1%
1/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Influenza like illness
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
29.2%
7/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
36.0%
9/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
35.0%
21/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Pyrexia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
20.0%
5/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
5/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Injection site reaction
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.7%
4/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Injection site pain
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.3%
2/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
General disorders
Injection site erythema
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.0%
2/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
3.3%
2/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.49%
1/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
4.2%
1/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.7%
4/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
12.5%
3/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.7%
7/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
8.0%
2/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
5.0%
3/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Vaginal candidiasis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Infections and infestations
Wound
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
11.1%
1/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
6.2%
1/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/204 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/206 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/24 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/25 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/60 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/9 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/16 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/34 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
0.00%
0/36 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
7.1%
1/14 • ITP: Baseline up to 96 weeks; OLMP: Baseline up to 96 weeks; LTFU: Baseline up to 48 weeks
ITP Safety analysis set(SAF). OLMP SAF: participants who received atleast 1dose of ITP study drug, converted to CDMS in ITP, entered OLMP and received atleast 1dose of OLMP study drug. LTFU (Treated)SAF: Participants who converted to McDonald MS(2005)during ITP, completed ITP 96-weeks and entered LTFU and treated with cladribine when entering LTFU. LTFU(Not-Treated) SAF:Participants who completed ITP 96-weeks and entered LTFU for safety follow-up and didn't receive study drug upon entry to LTFU.
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER