Trial Outcomes & Findings for Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma (NCT NCT00574288)
NCT ID: NCT00574288
Last Updated: 2018-04-27
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)
Results posted on
2018-04-27
Participant Flow
Participant milestones
| Measure |
Part 1 - <4 mg/kg
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 4 mg/kg
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 16 mg/kg
Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2 - 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2 - 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
3
|
3
|
3
|
3
|
30
|
42
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
20
|
3
|
3
|
2
|
2
|
26
|
28
|
Reasons for withdrawal
| Measure |
Part 1 - <4 mg/kg
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 4 mg/kg
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 16 mg/kg
Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2 - 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2 - 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
25
|
21
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Overall Study
Progressive Disease
|
17
|
2
|
3
|
2
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Part 1 - <4 mg/kg
n=20 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 4 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 8 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 16 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 24 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2 - 8 mg/kg
n=30 Participants
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2 - 16 mg/kg
n=42 Participants
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
21 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
63 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
41 Participants
n=40 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 9.24 • n=93 Participants
|
64 years
STANDARD_DEVIATION 2 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 6.11 • n=27 Participants
|
53 years
STANDARD_DEVIATION 1.73 • n=483 Participants
|
59 years
STANDARD_DEVIATION 9.54 • n=36 Participants
|
58.6 years
STANDARD_DEVIATION 10.05 • n=10 Participants
|
63.8 years
STANDARD_DEVIATION 8.27 • n=115 Participants
|
61.4 years
STANDARD_DEVIATION 9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
21 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
71 Participants
n=40 Participants
|
|
Region of Enrollment
Denmark
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
30 Participants
n=40 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
|
Region of Enrollment
Sweden
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
22 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
|
No. of Prior Lines of Therapy
<= 3 Lines
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
26 Participants
n=40 Participants
|
|
No. of Prior Lines of Therapy
> 3 Lines
|
18 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
78 Participants
n=40 Participants
|
|
Refractory to proteasome inhibitor (PI)/immunomodulatory agent (IMiD)
Both a PI and IMiD
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
54 Participants
n=40 Participants
|
|
Refractory to proteasome inhibitor (PI)/immunomodulatory agent (IMiD)
PI only
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
|
Refractory to proteasome inhibitor (PI)/immunomodulatory agent (IMiD)
IMiD only
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
|
Refractory to proteasome inhibitor (PI)/immunomodulatory agent (IMiD)
None
|
20 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=20 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
n=3 Participants
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
n=30 Participants
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
n=42 Participants
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
19 participants
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
30 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Up to Week 28 (for Part 1) and Week 27 (for Part 2)Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\<) 4 mg/kg doses were considered under the therapeutic levels.
Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein level \< 100mg/24 hours; PR: \>= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>= 90% or to \<200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=3 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
n=3 Participants
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
n=30 Participants
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
n=42 Participants
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
35.7 percentage of participants
Interval 21.6 to 52.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 28Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\<) 4 mg/kg doses were considered under the therapeutic levels.
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=3 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
n=3 Participants
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
n=3 Participants
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Time to Response
Time to first response
|
NA months
Interval 1.2 to
Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
NA months
Median and CI was not estimable due to insufficient number of participants with events.
|
8.4 months
Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.
|
1.9 months
Interval 0.5 to 1.9
|
—
|
—
|
—
|
|
Part 1: Time to Response
Time to best response
|
NA months
Interval 1.2 to
Median and upper limit of CI was not estimable due to insufficient number of participants with events.
|
NA months
Median and CI was not estimable due to insufficient number of participants with events.
|
8.4 months
Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of "time to event" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.
|
1.9 months
Interval 0.5 to 1.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 27Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 g/dL); urine M-component and/or (the absolute increase must be \>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be \>10 mg/dL); Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=30 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=42 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Time to Progression (TTP)
|
2.4 months
Interval 1.4 to 3.5
|
5.6 months
Interval 4.7 to
Upper limit of CI was not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 27Population: Subset of All-Treated Analysis Set included those who had overall response in Part 2.
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=3 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=15 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier
|
6.9 months
Interval 6.2 to 10.6
|
NA months
Interval 5.6 to
Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 27Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=30 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=42 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Progression-Free Survival
|
2.4 months
Interval 1.4 to 3.5
|
5.6 months
Interval 4.2 to 8.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 27Population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=30 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=42 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Time to Response
Time to first response
|
1.36 months
Standard Deviation 0.774
|
1.33 months
Standard Deviation 0.955
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Time to Response
Time to best response
|
1.36 months
Standard Deviation 0.774
|
2.46 months
Standard Deviation 2.800
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Time to Response
Time to VGPR or better response
|
—
|
0.49 months
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 3 yearsPopulation: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Outcome measures
| Measure |
Part 1: Daratumumab Less Than (<) 4 mg/kg
n=30 Participants
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 4 mg/kg
n=42 Participants
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 8 mg/kg
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1:Daratumumab 24 mg/kg
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2: Daratumumab 8 mg/kg
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2: Daratumumab 16 mg/kg
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Overall Survival
|
18.2 months
Interval 7.5 to 22.6
|
34.3 months
Interval 19.9 to
Upper limit of CI was not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 - <4 mg/kg
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 1 - 4 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - 8 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - 16 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - 24 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 - 8 mg/kg
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Part 2 - 16 mg/kg
Serious events: 16 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 - <4 mg/kg
n=20 participants at risk
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 4 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 8 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 16 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 24 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2 - 8 mg/kg
n=30 participants at risk
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2 - 16 mg/kg
n=42 participants at risk
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Confusional State
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Chest Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Oedema Peripheral
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Immune system disorders
Cytokine Release Syndrome
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Metapneumovirus Infection
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Varicella
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Injury, poisoning and procedural complications
Limb Traumatic Amputation
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Crossmatch Incompatible
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Free Haemoglobin Present
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Amnesia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Vith Nerve Paralysis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
Other adverse events
| Measure |
Part 1 - <4 mg/kg
n=20 participants at risk
Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 4 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 8 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 16 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 1 - 24 mg/kg
n=3 participants at risk
Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
Part 2 - 8 mg/kg
n=30 participants at risk
Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
|
Part 2 - 16 mg/kg
n=42 participants at risk
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
26.7%
8/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
26.2%
11/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Viral Infection
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Electrocardiogram QT Prolonged
|
25.0%
5/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Free Haemoglobin Present
|
20.0%
4/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Haptoglobin Decreased
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Investigations
Lymphocyte Count Decreased
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
4/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Haemolysis
|
15.0%
3/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Monocytopenia
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
3/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Eye disorders
Ocular Hyperaemia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Eye disorders
Vision Blurred
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
30.0%
9/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
14.3%
6/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Lip Oedema
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Mouth Ulceration
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
23.8%
10/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
16.7%
5/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Chest Discomfort
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Chest Pain
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Chills
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Fatigue
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
43.3%
13/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
45.2%
19/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Influenza Like Illness
|
15.0%
3/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Oedema Peripheral
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
General disorders
Pyrexia
|
35.0%
7/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
40.0%
12/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
21.4%
9/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Herpes Zoster
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
23.3%
7/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
38.1%
16/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Enzyme Abnormality
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
19.0%
8/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
14/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
20.0%
6/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
20.0%
6/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
14.3%
6/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Skin
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
16.7%
5/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
9.5%
4/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
16.7%
5/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Renal and urinary disorders
Proteinuria
|
45.0%
9/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
100.0%
3/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Renal and urinary disorders
Renal Impairment
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
20.0%
6/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
26.2%
11/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
26.7%
8/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
16.7%
7/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis Allergic
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
16.7%
7/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
11.9%
5/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
40.0%
12/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
23.8%
10/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat Tightness
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
10.0%
3/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
33.3%
1/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
13.3%
4/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
4.8%
2/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Vascular disorders
Flushing
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
3.3%
1/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Vascular disorders
Hot Flush
|
0.00%
0/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
6.7%
2/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
2.4%
1/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
66.7%
2/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
7.1%
3/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/3 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/30 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
0.00%
0/42 • Up to Week 28 (for Part 1) and approximately 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER