Trial Outcomes & Findings for Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma (NCT NCT02441686)
NCT ID: NCT02441686
Last Updated: 2026-01-13
Results Overview
4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Participants were followed up to 12 weeks.
Results posted on
2026-01-13
Participant Flow
Participants were enrolled from December 2015 to June 2017.
Participant milestones
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Induction
STARTED
|
46
|
|
Induction
Safety
|
42
|
|
Induction
Progression-free Survival Evaluable
|
41
|
|
Induction
Evaluable for Induction Response
|
40
|
|
Induction
Received Autologous Stem Cell Transplant (ASCT)
|
15
|
|
Induction
COMPLETED
|
38
|
|
Induction
NOT COMPLETED
|
8
|
|
Maintenance
STARTED
|
38
|
|
Maintenance
Safety
|
35
|
|
Maintenance
COMPLETED
|
0
|
|
Maintenance
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Induction
Adverse Event
|
4
|
|
Induction
Complicating disease
|
1
|
|
Induction
Physician Decision
|
1
|
|
Induction
Withdrawal by Subject
|
1
|
|
Induction
Did not receive treatment
|
1
|
|
Maintenance
Remaining on Treatment
|
23
|
|
Maintenance
Physician Decision
|
1
|
|
Maintenance
Adverse Event
|
3
|
|
Maintenance
Progressive Disease
|
10
|
|
Maintenance
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=46 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Age, Continuous
|
61.5 years
n=210 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=210 Participants
|
|
ECOG Performance Score (PS)
ECOG PS 0
|
19 participants
n=210 Participants
|
|
ECOG Performance Score (PS)
ECOG PS 1
|
21 participants
n=210 Participants
|
|
ECOG Performance Score (PS)
ECOG PS 2
|
2 participants
n=210 Participants
|
|
ECOG Performance Score (PS)
Unknown
|
4 participants
n=210 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 12 weeks.Population: Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.
4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=40 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
4-Cycle Induction Overall Response Rate (ORR)
|
95 percentage of participants
Interval 85.0 to 99.0
|
PRIMARY outcome
Timeframe: Participants were followed up to 24 weeks.Population: Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.
Induction ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during induction therapy either 4 cycles or 8 cycles of combination therapy. Response on ASCT is not included.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=40 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Induction Overall Response Rate (ORR)
|
97.5 percentage of participants
Interval 89.0 to 99.0
|
PRIMARY outcome
Timeframe: Participants were followed up to 12 weeks.Population: Safety- all treated population.
Four-cycle induction PN rate was defined as the proportion of participants who experienced peripheral neuropathy includes any attribution and any grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) during the first 4 cycles of induction therapy.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=42 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Four-cycle Induction Peripheral Neuropathy (PN) Rate
|
0.71 proportion of participants
Interval 0.58 to 0.83
|
PRIMARY outcome
Timeframe: Participants were followed up to 24 weeks.Population: The analysis population is comprised of all treated participants.
Grade 3-4 induction peripheral neuropathy rate was defined as the proportion of participants who experienced grade 3 or 4 peripheral neuropathy based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms during induction therapy (4 cycles RsqVd for ASCT patients and 8 cycles for non-ASCT patients).
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=42 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Grade 3-4 Induction Peripheral Neuropathy Rate
|
0.07 proportion of participants
Interval 0.02 to 0.17
|
SECONDARY outcome
Timeframe: Disease was assessed up to 41.2 months.Median TTP based on KM method is defined as the time from first dose of treatment to the first progression event or censored at date last disease assessment. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=41 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Median Time to Progression (TTP)
|
NA Months
Interval 29.7 to
Limited number of participants progressed during the observation period.
|
SECONDARY outcome
Timeframe: Median follow up for PFS is 13.4 months with the relevant observation timepoint equal to 1 year.1-year PFS is the probability estimate at 1 year based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression or death from any cause, censored at the date last known progression-free for those who have not progressed or died. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=41 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
1-Year Progression Free Survival (PFS) Probability
|
89.2 percentage probability
Interval 79.2 to 99.3
|
SECONDARY outcome
Timeframe: Disease was assessed up to 41.2 months.Population: The analysis population is comprised of participants who achieved partial response.
DOR was defined at the time from the first assessment indicating PR or better response to the first progression (PD) event based on IMWG criteria.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=40 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
Median Duration of Response (DOR)
|
NA Months
Interval 24.2 to
The data are not mature because follow-up for events is not long enough. As such, the median was not reached and the upper bound 95% CI could not be estimated.
|
SECONDARY outcome
Timeframe: Survival was assessed up to 1 year.1-year OS rate was defined as the percentage of participants alive at 1 year.
Outcome measures
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
n=42 Participants
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|
|
1-year Overall Survival (OS) Rate
|
100 percentage of participants
Interval 93.0 to 100.0
|
Adverse Events
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase
n=42 participants at risk
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
|
Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
n=35 participants at risk
Maintenance follows induction with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|---|
|
Eye disorders
Retinal vascular disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Edema limbs
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Fatigue
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Lethargy
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Mania
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
Other adverse events
| Measure |
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase
n=42 participants at risk
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
|
Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
n=35 participants at risk
Maintenance follows induction with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Blood and lymphatic system disorders
Anemia
|
26.2%
11/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Anxiety
|
16.7%
7/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
14.3%
5/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Atrial flutter
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.0%
13/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
25.7%
9/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Bacteraemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Balance disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Bloating
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Blurred vision
|
16.7%
7/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Bradycardia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Cardiac arrthymia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Cataract
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Chills
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
14.3%
5/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Cognitive disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Cold sweat
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Concentration impairment
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Constipation
|
54.8%
23/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
17.1%
6/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
11.4%
4/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Creatinine increased
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Depression
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Diarrhea
|
26.2%
11/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
34.3%
12/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Dizziness
|
23.8%
10/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Dry eye
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Dysgeusia
|
19.0%
8/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Edema face
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Edema limbs
|
38.1%
16/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
20.0%
7/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Erythema
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
External ear pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Eye discharge
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Eye infection
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Eye irritation
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Eye oedema
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Eyelid infection
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Fall
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Fatigue
|
57.1%
24/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
25.7%
9/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Fever
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Flu like symptoms
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Gastrointestinal infection
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
GGT increased
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Gingival pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Headache
|
26.2%
11/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Herpes simplex
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Hot flashes
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Hyperchloraemia
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Hypercholesterolaemia
|
54.8%
23/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
31.4%
11/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
14/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
31.4%
11/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Hyperphosphatemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Hypertension
|
16.7%
7/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
14.3%
5/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
14/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
22.9%
8/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Hypocholesterolaemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
7/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
17.1%
6/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Hypotension
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Influenza
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Injection site erythema
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Insomnia
|
31.0%
13/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
14.3%
5/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Irritability
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Libido decreased
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Localized edema
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Lung infection
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Lymphocyte count decreased
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Malaise
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Memory impairment
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Mood swings
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Movements involuntary
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
10/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
22.9%
8/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
8/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Neutrophil count decreased
|
38.1%
16/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
51.4%
18/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Pain
|
23.8%
10/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
38.1%
16/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
22.9%
8/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Papulopustular rash
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
78.6%
33/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
31.4%
11/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Personality change
|
14.3%
6/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Platelet count decreased
|
14.3%
6/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
17.1%
6/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.5%
17/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Renal impairment
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Psychiatric disorders
Restlessness
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Retinal vascular disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Cardiac disorders
Sinus bradycardia
|
7.1%
3/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Sinusitis
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Skin infection
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
5.7%
2/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Endocrine disorders
Steroid diabetes
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Stomach pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Stomatitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Taste disorder
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Temperature regulation disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
8.6%
3/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
General disorders
Tongue blistering
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Tooth disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Transaminitis
|
31.0%
13/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
20.0%
7/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Tremor
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Upper respiratory infection
|
38.1%
16/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
40.0%
14/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Renal and urinary disorders
Urine flow decreased
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Infections and infestations
Varicella zoster virus infection
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Visual disorder
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
4/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
11.4%
4/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Nervous system disorders
Weakness in right arm
|
2.4%
1/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Weight gain
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
0.00%
0/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
Weight loss
|
4.8%
2/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Investigations
White blood cell decreased
|
11.9%
5/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
17.1%
6/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/42 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
2.9%
1/35 • AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place