Trial Outcomes & Findings for Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma (NCT NCT01496118)
NCT ID: NCT01496118
Last Updated: 2022-02-02
Results Overview
Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1: Grade 4 neutropenia for \>7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia \> 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting \>72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
80 participants
Primary outcome timeframe
28 days from the start of study treatment
Results posted on
2022-02-02
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
3
|
3
|
31
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
3
|
3
|
3
|
31
|
30
|
Reasons for withdrawal
| Measure |
Dose Level 1
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16; cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg by mouth D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
2
|
3
|
1
|
2
|
2
|
14
|
10
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
6
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
6
|
10
|
|
Overall Study
Conditions requiring other treatment not permitted by protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
1
|
6
|
3
|
Baseline Characteristics
Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=4 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 4
n=31 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 6
n=30 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
54 years
STANDARD_DEVIATION 13.53 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
71.3 years
STANDARD_DEVIATION 8.08 • n=21 Participants
|
67.3 years
STANDARD_DEVIATION 13.05 • n=10 Participants
|
65.7 years
STANDARD_DEVIATION 10.14 • n=115 Participants
|
65.1 years
STANDARD_DEVIATION 11.16 • n=6 Participants
|
65 years
STANDARD_DEVIATION 10.56 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
68 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
66 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Pre-treatment ECOG
0 - Asymptomatic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
38 Participants
n=6 Participants
|
|
Pre-treatment ECOG
1 - Symptomatic but completely ambulatory
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
|
Pre-treatment ECOG
2 - symptomatic, <50% in bed during the day
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
00 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 28 days from the start of study treatmentPopulation: Includes all Phase 1 patients receiving assigned study dosing
Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1: Grade 4 neutropenia for \>7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia \> 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting \>72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
n=3 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 6 yearsPopulation: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Defined as the percentage of patients with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) according to International Myeloma Working Group Uniform Response Criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; disappearance of soft tissue plasmacytomas. VGPR=≥90% reduction from baseline serum; urine M-protein level 100mg for 24h. PR=≥50% reduction from baseline in serum M-protein; disappearance of any soft tissue plasmacytomas.
Outcome measures
| Measure |
Dose Level 1
n=31 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=32 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Phase II: Overall Response Rate
|
74 percentage of participants
|
84 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 yearsPopulation: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Measured from date of first treatment until date of first documented progression as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca \>11.5mg/dL) for patients without hypercalcemia at baseline
Outcome measures
| Measure |
Dose Level 1
n=31 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=32 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Time-to-progression (TTP)
|
11.6 months
Interval 4.9 to 22.1
|
11.7 months
Interval 5.6 to 14.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 yearsPopulation: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Measured from date of first protocol treatment until date of tumor progression or death as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca \>11.5mg/dL) for patients without hypercalcemia at baseline
Outcome measures
| Measure |
Dose Level 1
n=31 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=32 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Progression-free-survival (PFS)
|
12.1 months
Interval 5.8 to 22.4
|
10.3 months
Interval 6.1 to 13.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 yearsPopulation: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Measured from time of first study treatment until date of death or date last known alive.
Outcome measures
| Measure |
Dose Level 1
n=31 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=32 Participants
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Overall-survival (OS)
|
29.2 months
Interval 22.0 to 50.4
|
44.6 months
Interval 20.8 to
Upper confidence limit is not estimable by Kaplan Meier method due to insufficient observed events
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Expansion Dose Level 4
Serious events: 16 serious events
Other events: 31 other events
Deaths: 20 deaths
Expansion Dose Level 6
Serious events: 13 serious events
Other events: 30 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 4
n=31 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 6
n=30 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
General disorders
Chest pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Renal and urinary disorders
Calculus urinary
|
25.0%
1/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
Other adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 2
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 3
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 4
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Dose Level 5
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
|
Dose Level 6
n=3 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 4
n=31 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
Expansion Dose Level 6
n=30 participants at risk
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16
Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
panobinostat: Specified dose on specified days
carfilzomib: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
4/4 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
74.2%
23/31 • From date of first treatment up to 6 years
|
70.0%
21/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
67.7%
21/31 • From date of first treatment up to 6 years
|
63.3%
19/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
4/4 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
67.7%
21/31 • From date of first treatment up to 6 years
|
50.0%
15/30 • From date of first treatment up to 6 years
|
|
General disorders
Fatigue
|
100.0%
4/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
48.4%
15/31 • From date of first treatment up to 6 years
|
53.3%
16/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
51.6%
16/31 • From date of first treatment up to 6 years
|
43.3%
13/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
48.4%
15/31 • From date of first treatment up to 6 years
|
50.0%
15/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
4/4 • From date of first treatment up to 6 years
|
100.0%
3/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
45.2%
14/31 • From date of first treatment up to 6 years
|
26.7%
8/30 • From date of first treatment up to 6 years
|
|
General disorders
Pyrexia
|
50.0%
2/4 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
35.5%
11/31 • From date of first treatment up to 6 years
|
33.3%
10/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
19.4%
6/31 • From date of first treatment up to 6 years
|
26.7%
8/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
32.3%
10/31 • From date of first treatment up to 6 years
|
36.7%
11/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
29.0%
9/31 • From date of first treatment up to 6 years
|
40.0%
12/30 • From date of first treatment up to 6 years
|
|
General disorders
Chills
|
50.0%
2/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
22.6%
7/31 • From date of first treatment up to 6 years
|
23.3%
7/30 • From date of first treatment up to 6 years
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
25.8%
8/31 • From date of first treatment up to 6 years
|
33.3%
10/30 • From date of first treatment up to 6 years
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
35.5%
11/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
2/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
25.8%
8/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
2/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
16.1%
5/31 • From date of first treatment up to 6 years
|
23.3%
7/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
30.0%
9/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
22.6%
7/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
19.4%
6/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
16.1%
5/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
19.4%
6/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
20.0%
6/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
23.3%
7/30 • From date of first treatment up to 6 years
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
20.0%
6/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
20.0%
6/30 • From date of first treatment up to 6 years
|
|
General disorders
Asthenia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
General disorders
Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
16.1%
5/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
16.7%
5/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
12.9%
4/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Nervous system disorders
Dysgeusia
|
50.0%
2/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
13.3%
4/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
2/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
General disorders
Influenza Like Illness
|
25.0%
1/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • From date of first treatment up to 6 years
|
66.7%
2/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
10.0%
3/30 • From date of first treatment up to 6 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Immune system disorders
Seasonal Allergy
|
50.0%
2/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Investigations
Blood Alkaline Phosphatase
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
6.5%
2/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
6.7%
2/30 • From date of first treatment up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
9.7%
3/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
25.0%
1/4 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/31 • From date of first treatment up to 6 years
|
0.00%
0/30 • From date of first treatment up to 6 years
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
25.0%
1/4 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
33.3%
1/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
0.00%
0/3 • From date of first treatment up to 6 years
|
3.2%
1/31 • From date of first treatment up to 6 years
|
3.3%
1/30 • From date of first treatment up to 6 years
|
Additional Information
Dr. Jesus Berdeja
Sarah Cannon Development Innovations, LLC
Phone: 844-710-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place