Trial Outcomes & Findings for Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma (NCT NCT04477200)
NCT ID: NCT04477200
Last Updated: 2026-05-14
Results Overview
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)
Results posted on
2026-05-14
Participant Flow
1 subject was enrolled into Phase 1- Recurrent, but chose to not start study treatment. 2 Subjects were enrolled into Phase 1- Newly diagnosed, but did not start treatment.
Participant milestones
| Measure |
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 5
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
3
|
4
|
19
|
4
|
11
|
16
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
3
|
4
|
17
|
3
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
5
|
5
|
Reasons for withdrawal
| Measure |
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 5
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
4
|
|
Overall Study
Noncompliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
Baseline characteristics by cohort
| Measure |
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
n=3 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
n=4 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 5
n=19 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
n=4 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
n=11 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
n=16 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
13 Participants
n=825 Participants
|
2 Participants
n=2 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
42 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
3 Participants
n=488 Participants
|
6 Participants
n=825 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
23 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
5 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
21 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
14 Participants
n=825 Participants
|
4 Participants
n=2 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
44 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
1 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
3 Participants
n=97 Participants
|
4 Participants
n=488 Participants
|
18 Participants
n=825 Participants
|
4 Participants
n=2 Participants
|
11 Participants
n=3 Participants
|
16 Participants
n=3 Participants
|
64 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
3 Participants
n=97 Participants
|
4 Participants
n=488 Participants
|
15 Participants
n=825 Participants
|
4 Participants
n=2 Participants
|
10 Participants
n=3 Participants
|
16 Participants
n=3 Participants
|
60 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=825 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=1512 Participants
|
2 participants
n=504 Participants
|
2 participants
n=2016 Participants
|
2 participants
n=99 Participants
|
3 participants
n=97 Participants
|
4 participants
n=488 Participants
|
19 participants
n=825 Participants
|
4 participants
n=2 Participants
|
11 participants
n=3 Participants
|
16 participants
n=3 Participants
|
65 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: At 1 weekPopulation: only phase 0 subjects were analyzed
The concentration of MPA (the active metabolite of mycophenolate mofetil \[MMF\]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration. This measure includes all phase 0 participants.
Outcome measures
| Measure |
Phase 1 - Recurrent GBM / GS - Level 5
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
n=2 Participants
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
Enhancing Tumor
|
—
|
1.8 nmol/g
Interval 1.5 to 2.11
|
—
|
—
|
1.87 nmol/g
Interval 1.55 to 2.19
|
2.65 nmol/g
Interval 2.15 to 3.15
|
2.65 nmol/g
Interval 1.74 to 3.56
|
—
|
—
|
—
|
|
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
Non- Enhancing Tumor
|
—
|
1.25 nmol/g
Interval 0.72 to 1.79
|
—
|
—
|
1.11 nmol/g
Interval 0.76 to 1.45
|
0.81 nmol/g
Interval 0.81 to 0.81
|
1.53 nmol/g
Interval 1.01 to 2.05
|
—
|
—
|
—
|
|
Concentration of Mycophenolic Acid (MPA) in Tumor Tissue in Phase 0 Participants
Normal Brain
|
—
|
0.64 nmol/g
Interval 0.4 to 0.88
|
—
|
—
|
—
|
2.55 nmol/g
Interval 2.55 to 2.55
|
2.59 nmol/g
Interval 1.66 to 3.51
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days following completion of MMF + RT (up to ~9 weeks)Population: Only phase 1 recurrent subjects reported
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only phase 1 participants with recurrent GBM/GS.
Outcome measures
| Measure |
Phase 1 - Recurrent GBM / GS - Level 5
n=19 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
n=3 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
n=4 Participants
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Recurrent Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level
|
0 number of patients reporting a DLT
|
—
|
0 number of patients reporting a DLT
|
0 number of patients reporting a DLT
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks)Population: Only Phase 1 newly diagnosed subjects analyzed
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
Outcome measures
| Measure |
Phase 1 - Recurrent GBM / GS - Level 5
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
n=4 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
n=10 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
n=16 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT1 Period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 number of patients reporting a DLT
|
0 number of patients reporting a DLT
|
5 number of patients reporting a DLT
|
PRIMARY outcome
Timeframe: During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)Population: Only phase 1 newly diagnosed subjects analyzed
DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This measure includes only newly diagnosed phase 1 participants.
Outcome measures
| Measure |
Phase 1 - Recurrent GBM / GS - Level 5
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Mycophenolate mofetil
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Recurrent GBM / GS - Level 3
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
Mycophenolate mofetil; radiation therapy
Radiation Therapy: 40.5 Gy in 15 fractions
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Mycophenolate mofetil
Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Mycophenolate mofetil
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Mycophenolate mofetil
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection
Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
n=4 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
n=6 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
n=16 Participants
Mycophenolate mofetil; radiation therapy; temozolomide
Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Newly Diagnosed Phase 1 Participants Who Experience Dose-limiting Toxicities (DLTs) at Each Dose Level -- DLT2 Period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 number of patients reporting a DLT
|
1 number of patients reporting a DLT
|
0 number of patients reporting a DLT
|
SECONDARY outcome
Timeframe: After one week of MMF administrationThe concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale. This measure includes all phase 0 participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 days following completion of MMF + RT (up to ~9 weeks)Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes all phase 1 participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 days following completion of MMF with adjuvant temozolomide (up to ~15 months)Toxicities at each dose level will be tabulated, categorized by grade and attribution. This measure includes only newly diagnosed phase 1 participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study stops or death; up to approximately 3 years.Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall. This measure includes only phase 1 participants with recurrent GBM/GS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study stops or death; up to approximately 3 years.PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study stops or death; up to approximately 3 years.FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria. This measure includes only phase 1 participants with recurrent GBM/GS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study stops or death; up to approximately 3 years.OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method. This measure includes only phase 1 participants with recurrent GBM/GS.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 - Recurrent GBM / GS - Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1 - Recurrent GBM / GS - Level 4
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1 - Recurrent GBM / GS - Level 5
Serious events: 2 serious events
Other events: 16 other events
Deaths: 12 deaths
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1 - Newly Diagnosed GBM / GS - Level 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1 - Newly Diagnosed GBM / GS- Level 4
Serious events: 4 serious events
Other events: 10 other events
Deaths: 8 deaths
Phase 1 - Newly Diagnosed GBM / GS- Level 5
Serious events: 9 serious events
Other events: 16 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Phase 1 - Recurrent GBM / GS - Level 3
n=3 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
n=4 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 5
n=19 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
n=4 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
n=11 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
n=16 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dysphasia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Encephalopathy
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Blood and lymphatic system disorders
Intracranial hemorrhage
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Blood and lymphatic system disorders
Aortic injury
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Cerebrospinal fluid leakage
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Fall
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Hypokalemia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Nervous system disorders
Left sided hemiparesis
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Seizure
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
27.3%
3/11 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
Other adverse events
| Measure |
Phase 1 - Recurrent GBM / GS - Level 3
n=3 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 4
n=4 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 1 - Recurrent GBM / GS - Level 5
n=19 participants at risk
Mycophenolate mofetil; radiation therapy Radiation Therapy: 40.5 Gy in 15 fractions Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT.
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 2
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 500mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 3
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 4
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 0 - Recurrent Glioblastoma (GBM) / Gliosarcoma (GS) - Level 5
n=2 participants at risk
Mycophenolate mofetil Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to re-resection Re-resection (as part of standard of care): Re-resection or biopsy of tumor as part of standard of care
|
Phase 1 - Newly Diagnosed GBM / GS - Level 3
n=4 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 4
n=11 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 1500mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
Phase 1 - Newly Diagnosed GBM / GS- Level 5
n=16 participants at risk
Mycophenolate mofetil; radiation therapy; temozolomide Temozolomide: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
Mycophenolate Mofetil: 2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
Radiation Therapy: 60 Gy in 30 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cushingoid
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
75.0%
3/4 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
36.8%
7/19 • Number of events 7 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
100.0%
2/2 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
100.0%
4/4 • Number of events 5 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
72.7%
8/11 • Number of events 9 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
81.2%
13/16 • Number of events 19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
36.8%
7/19 • Number of events 7 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
2/4 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
27.3%
3/11 • Number of events 4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
37.5%
6/16 • Number of events 6 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Memory impairment
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Seizure
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
1/2 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
10.5%
2/19 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
43.8%
7/16 • Number of events 7 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
31.6%
6/19 • Number of events 6 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
8/16 • Number of events 8 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dizziness
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dysphasia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
10.5%
2/19 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Blood and lymphatic system disorders
Intracranial hemorrhage
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
21.1%
4/19 • Number of events 5 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
2/4 • Number of events 4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
63.6%
7/11 • Number of events 12 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
93.8%
15/16 • Number of events 25 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
31.6%
6/19 • Number of events 7 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
2/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
81.8%
9/11 • Number of events 10 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
87.5%
14/16 • Number of events 14 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
15.8%
3/19 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Anorexia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Arthralgia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
31.2%
5/16 • Number of events 6 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Confusion
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
100.0%
4/4 • Number of events 5 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
63.6%
7/11 • Number of events 7 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
75.0%
12/16 • Number of events 14 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dyspepsia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Dysphasia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Pain in extremity
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
37.5%
6/16 • Number of events 10 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Scalp pain
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Tremor
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
50.0%
2/4 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Weight loss
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
12.5%
2/16 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dry Mouth
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Fall
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dysesthesia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Facial muscle weakness
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Shingles
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Agitation
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Bullous dermatitis
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Concentration impairment
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Eye disorders
Eye infection
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Hiccups
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Sinusitis
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Thrush
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
25.0%
1/4 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Anemia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Dysphagia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Gallbladder pain
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Hyperglycemia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Investigations
Hypoglycemia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
9.1%
1/11 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Mucositis oral
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
18.2%
2/11 • Number of events 2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/16 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Arthritis
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Ataxia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Bronchospasm
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
General disorders
Hydrocephalus
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/19 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/2 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/4 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
0.00%
0/11 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
6.2%
1/16 • Number of events 1 • Adverse Events are collected from the time of initial study enrollment through 30 days after the last dose of MMF, approximately 6 months. Data is currently being collected. All Data collected through the primary completion date has been reported. Data broken down by dose is not yet available as data is still ongoing.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place