Trial Outcomes & Findings for A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment (NCT NCT02927769)
NCT ID: NCT02927769
Last Updated: 2025-02-10
Results Overview
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
COMPLETED
PHASE2
72 participants
From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)
2025-02-10
Participant Flow
All participants entered the Induction phase and received treatment with nivolumab + brentuximab vedotin (N+ Bv) Participants moved into the Intensification phase if they received treatment with brentuximab + bendamustine (Bv + B). Participants moved into the Consolidation Phase if they received radiation therapy (Cohort 1) or high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (Cohort 2).
Participant milestones
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Induction Phase
STARTED
|
28
|
44
|
|
Induction Phase
COMPLETED
|
27
|
42
|
|
Induction Phase
NOT COMPLETED
|
1
|
2
|
|
Consolidation Phase
STARTED
|
22
|
32
|
|
Consolidation Phase
COMPLETED
|
22
|
32
|
|
Consolidation Phase
NOT COMPLETED
|
0
|
0
|
|
Intensification Phase
STARTED
|
6
|
11
|
|
Intensification Phase
COMPLETED
|
5
|
11
|
|
Intensification Phase
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Induction Phase
Study drug toxicity
|
1
|
1
|
|
Induction Phase
Disease progression
|
0
|
1
|
|
Intensification Phase
Study drug toxicity
|
1
|
0
|
Baseline Characteristics
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
Baseline characteristics by cohort
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.0 Years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
16.2 Years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
16.5 Years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1
|
92.9 Percent of participants
Interval 79.2 to 98.7
|
—
|
PRIMARY outcome
Timeframe: At 3 years post first dose of study therapyPopulation: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1
|
87.5 Percent of participants
Interval 70.6 to 95.0
|
—
|
PRIMARY outcome
Timeframe: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)Population: All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2
|
88.6 Percent of participants
Interval 77.6 to 95.4
|
—
|
SECONDARY outcome
Timeframe: From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).Population: All treated participants.
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)
|
96.4 Percent of participants
Interval 84.1 to 99.8
|
93.2 Percent of participants
Interval 83.3 to 98.1
|
SECONDARY outcome
Timeframe: At 3 years post first dose of study therapyPopulation: All treated participants.
Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)
|
95.2 Percent of participants
Interval 77.7 to 99.1
|
91.1 Percent of participants
Interval 78.4 to 96.5
|
SECONDARY outcome
Timeframe: From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)Population: All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).
Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response (PMR): * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=43 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
|
NA Months
Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.
|
NA Months
Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.
|
SECONDARY outcome
Timeframe: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).Population: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1
|
89.3 Percent of participants
Interval 74.6 to 97.0
|
—
|
SECONDARY outcome
Timeframe: At 3 years post first dose of study therapyPopulation: All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.
Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death . PD : Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease CMR: Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1
|
88.5 Percent of participants
Interval 72.8 to 95.4
|
—
|
SECONDARY outcome
Timeframe: From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)Population: All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.
The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2
|
86.4 Percent of participants
Interval 74.8 to 93.9
|
—
|
SECONDARY outcome
Timeframe: From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).Population: All treated participants.
Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR). Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator
|
100.0 Percent of participants
Interval 89.9 to 100.0
|
90.9 Percent of participants
Interval 80.4 to 96.8
|
SECONDARY outcome
Timeframe: At 3 years post first dosePopulation: All treated participants.
Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by investigator or death. Progressive Disease (PD): Lymph Nodes and Lesions: new growth or increase of \>= 50% in size from nadir. New or growing lesions outside the lymph nodes. Spleen: Significant increase in spleen size, either from a previously enlarged state or from normal size. New Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were be censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy forR2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Progression Free Survival (PFS) Rate at 3 Years by Investigator
|
95.8 Percent of participants
Interval 80.2 to 99.2
|
88.1 Percent of participants
Interval 74.8 to 94.6
|
SECONDARY outcome
Timeframe: From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)Population: All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).
Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, the DOR was censored on the date of last tumor assessment. Participants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete metabolic response (CMR): * Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Partial metabolic response: * Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Duration of Response (DOR) by Investigator
|
NA Months
Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.
|
NA Months
Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months).Population: All treated participants.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
The Number of Participants With Adverse Events (AEs)
|
26 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)Population: All treated participants.
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
The Number of Participants With Serious Adverse Events (SAEs)
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)Population: All treated participants with at least one on treatment TSH measurement.
The Number of Participants with Abnormal Laboratory Values for Specific Thyroid Tests.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH > ULN
|
6 Participants
|
8 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
5 Participants
|
4 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
4 Participants
|
5 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
1 Participants
|
3 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH < LLN
|
4 Participants
|
1 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH <LLN WITH TSH >= LLN AT BASELINE
|
4 Participants
|
1 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
3 Participants
|
1 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)Population: All treated participants with at least one on treatment measurement.
The Number of Participants with Abnormal Laboratory Values for Liver Tests.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT OR AST > 3XULN
|
8 Participants
|
5 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT OR AST> 5XULN
|
3 Participants
|
1 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT OR AST> 10XULN
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
TOTAL BILIRUBIN > 2XULN
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Abnormal Laboratory Values for Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).Population: All treated participants.
Temperature, blood pressure, and heart rate abnormalities reported as adverse events.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse
n=28 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse
n=44 Participants
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Pyrexia
|
7 Participants
|
23 Participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Tachycardia
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Sinus Bradycardia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Hypertension
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Hypotension
|
0 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Orthostatic hypotension
|
0 Participants
|
1 Participants
|
Adverse Events
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)
Serious adverse events
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)
n=22 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
\- Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
|
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)
n=6 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)
n=33 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
\- Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)
n=11 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Enteritis
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Chest pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Pyrexia
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
50.0%
3/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Immune system disorders
Hypersensitivity
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Otitis media
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
Other adverse events
| Measure |
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)
n=22 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
\- Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
|
Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)
n=6 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase).
* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).
* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)
n=33 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
\- Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
|
Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)
n=11 participants at risk
Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).
* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.
* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).
* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).
* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).
* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.
* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
6/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
15.2%
5/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Eye disorders
Eye pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
9/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
21.2%
7/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Coating in mouth
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.7%
5/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
39.4%
13/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Nausea
|
40.9%
9/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
50.0%
3/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
57.6%
19/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
100.0%
11/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
21.2%
7/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
50.0%
3/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
21.2%
7/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
54.5%
6/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Asthenia
|
18.2%
4/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Face oedema
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Fatigue
|
18.2%
4/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
21.2%
7/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Gait disturbance
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Influenza like illness
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Mucosal inflammation
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
30.3%
10/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
45.5%
5/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Oedema peripheral
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
51.5%
17/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
45.5%
5/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Immune system disorders
Drug hypersensitivity
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Immune system disorders
Hypersensitivity
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
6/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Device related infection
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Gastroenteritis
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Otitis media
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Rhinitis
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.2%
4/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
45.5%
5/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Injury, poisoning and procedural complications
Vascular access site pruritus
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Alanine aminotransferase increased
|
22.7%
5/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Amylase increased
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
3/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Blood bilirubin increased
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Body temperature increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Heart rate increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Lipase decreased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Lipase increased
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Lymphocyte count decreased
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Neutrophil count decreased
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Platelet count decreased
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
Weight decreased
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Investigations
White blood cell count decreased
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
24.2%
8/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
15.2%
5/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.6%
3/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Nervous system disorders
Headache
|
45.5%
10/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
33.3%
2/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
6/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Nervous system disorders
Presyncope
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
24.2%
8/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
3/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.7%
5/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.6%
3/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
15.2%
5/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
3.0%
1/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
4/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
6.1%
2/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
36.4%
4/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
2/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
6/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
16.7%
1/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
3/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
0.00%
0/6 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
12.1%
4/33 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in: 1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort. 2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER