Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01615029
Collaborator
(none)
45
8
1
162.2
5.6
0
Study Details
Study Description
Brief Summary
The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
Actual Study Start Date
:
Jun 26, 2012
Actual Primary Completion Date
:
Oct 2, 2015
Anticipated Study Completion Date
:
Dec 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daratumumab Participants will receive daratumumab along with Lenalidomide and dexamethasone. |
Drug: Part 1 (Dose Escalation): Daratumumab
Participants will receive intravenous (injection of a substance into a vein) infusion of daratumumab in an increased fashion from 2 milligram per kilogram (mg/kg) up to maximum dose of 16 mg/kg. Considering the safety and efficacy of dose in Part 1, recommended phase 2 dose (RP2D) for Part 2 of the study will be decided. A predose infusion of 10 percent (%) of the full dose of daratumumab will be administered a day before the first full infusion of the first cycle. Participants will receive 4 weekly infusions in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression.
Drug: Part 2 (Dose Expansion): Daratumumab
Participants will receive RP2D as determined in Part 1 of the study. Participants will receive 4 weekly infusions of RP2D in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression.
Drug: Lenalidomide
All participants (Part 1 and Part 2) will receive 25 mg lenalidomide orally (by mouth) from days 1 to 21 of each 28-day cycle until disease progression.
Drug: Dexamethasone
All participants (Part 1 and Part 2) will receive 40 mg (20 mg intravenously [injection of a substance into a vein]) dexamethasone once weekly. Participants older than 75 years or underweight (body mass index [BMI] less than [<] 18.5), the dexamethasone dose will be administered at a dose of 20 mg once weekly until disease progression.
|
Outcome Measures
Primary Outcome Measures
- Phase 1: Percentage of Participants With Overall Response Rate (ORR) [Up to 3 years]
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
- Phase 2: Percentage of Participants With Overall Response Rate (ORR) [Up to 3 years]
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
Secondary Outcome Measures
- Phase 2: Time to Progression (TTP) [Up to 3 years]
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. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; 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.
- Phase 2: Duration of Response [Up to 3 years]
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.
- Phase 2: Progression-Free Survival (PFS) [Up to 3 years]
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.
- Phase 1: Time to Response [Up to 3 years]
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.
- Phase 2: Time to Response [Up to 3 years]
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.
- Phase 2: Overall Survival (OS) [Up to 3 years]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
(Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
-
(Part 2) Have received at least 1 prior line of therapy for multiple myeloma
-
Be older than or be 18 years of age
-
Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
-
Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed
Exclusion Criteria:
-
Have previously received an allogenic stem cell transplant
-
Have received autologous stem cell transplant within 12 weeks before the first infusion
-
Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
-
Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston | Massachusetts | United States | ||
| 2 | Copenhagen Ø | Denmark | |||
| 3 | Vejle | Denmark | |||
| 4 | Lille Cedex | France | |||
| 5 | Nantes N/a | France | |||
| 6 | Vandoeuvre les Nancy | France | |||
| 7 | Utrecht | Netherlands | |||
| 8 | London | United Kingdom |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
- Principal Investigator: Torben Plesner, MD, Vejle Hospital
- Principal Investigator: Paul Richardson, MD, Dana Farber
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01615029
Other Study ID Numbers:
- CR101391
- GEN503
- DARA-GEN503
- 2011-005709-62
First Posted:
Jun 8, 2012
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Janssen Research & Development, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Period Title: Overall Study | |||||
| STARTED | 3 | 3 | 4 | 3 | 32 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 3 | 4 | 3 | 32 |
Baseline Characteristics
| Arm/Group Title | Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 4 | 3 | 32 | 45 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
62.7
(12.74)
|
62.7
(2.08)
|
57.5
(9.68)
|
67.3
(10.26)
|
59.7
(8.38)
|
60.4
(8.57)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
0
0%
|
1
33.3%
|
0
0%
|
2
66.7%
|
10
31.3%
|
13
28.9%
|
| Male |
3
100%
|
2
66.7%
|
4
100%
|
1
33.3%
|
22
68.8%
|
32
71.1%
|
| Region of Enrollment (participants) [Number] | ||||||
| Denmark |
2
66.7%
|
2
66.7%
|
1
25%
|
1
33.3%
|
5
15.6%
|
11
24.4%
|
| France |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
6
18.8%
|
7
15.6%
|
| Italy |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
8
25%
|
8
17.8%
|
| Netherlands |
0
0%
|
0
0%
|
3
75%
|
0
0%
|
6
18.8%
|
9
20%
|
| United Kingdom |
1
33.3%
|
1
33.3%
|
0
0%
|
1
33.3%
|
4
12.5%
|
7
15.6%
|
| United States |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
9.4%
|
3
6.7%
|
| Stage of Disease [International Staging System (ISS) (participants) [Number] | ||||||
| I |
0
0%
|
1
33.3%
|
4
100%
|
1
33.3%
|
15
46.9%
|
21
46.7%
|
| II |
2
66.7%
|
1
33.3%
|
0
0%
|
1
33.3%
|
14
43.8%
|
18
40%
|
| III |
1
33.3%
|
1
33.3%
|
0
0%
|
1
33.3%
|
3
9.4%
|
6
13.3%
|
| No. of Prior Lines of Therapy (participants) [Number] | ||||||
| 1 Line |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
15
46.9%
|
15
33.3%
|
| 2-3 Lines |
2
66.7%
|
3
100%
|
3
75%
|
2
66.7%
|
17
53.1%
|
27
60%
|
| >3 Lines |
1
33.3%
|
0
0%
|
1
25%
|
1
33.3%
|
0
0%
|
3
6.7%
|
| Refractory to Proteasome Inhibitor (PI)/Immunomodulatory drug (IMiD) (participants) [Number] | ||||||
| Both a PI and IMiD |
0
0%
|
0
0%
|
3
75%
|
1
33.3%
|
0
0%
|
4
8.9%
|
| PI only |
0
0%
|
2
66.7%
|
0
0%
|
0
0%
|
5
15.6%
|
7
15.6%
|
| IMiD only |
0
0%
|
1
33.3%
|
0
0%
|
1
33.3%
|
1
3.1%
|
3
6.7%
|
| None |
3
100%
|
0
0%
|
1
25%
|
1
33.3%
|
26
81.3%
|
31
68.9%
|
Outcome Measures
| Title | Phase 1: Percentage of Participants With Overall Response Rate (ORR) |
|---|---|
| Description | ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. |
| Arm/Group Title | Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|---|---|---|
| Arm/Group Description | Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 3 | 3 | 4 | 3 |
| Number (95% Confidence Interval) [Percentage of participants] |
100.0
3333.3%
|
100.0
3333.3%
|
75.0
1875%
|
66.7
2223.3%
|
| Title | Phase 2: Percentage of Participants With Overall Response Rate (ORR) |
|---|---|
| Description | ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 32 |
| Number (95% Confidence Interval) [Percentage of participants] |
81.3
2710%
|
| Title | Phase 2: Time to Progression (TTP) |
|---|---|
| Description | 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. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; 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. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 32 |
| Median (95% Confidence Interval) [Months] |
NA
|
| Title | Phase 2: Duration of Response |
|---|---|
| Description | 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. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Responders in Intent-to-Treat (ITT) population analysis set included. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 26 |
| Median (95% Confidence Interval) [Months] |
NA
|
| Title | Phase 2: Progression-Free Survival (PFS) |
|---|---|
| Description | 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. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 32 |
| Median (95% Confidence Interval) [Months] |
NA
|
| Title | Phase 1: Time to Response |
|---|---|
| Description | 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 Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Responders in all treated population analysis set included. |
| Arm/Group Title | Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|---|---|---|
| Arm/Group Description | Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 3 | 3 | 3 | 2 |
| Time to first response |
0.83
(0.266)
|
1.14
(0.682)
|
1.27
(0.494)
|
2.25
(0.488)
|
| Time to best response |
3.12
(2.938)
|
12.54
(8.494)
|
9.75
(9.532)
|
5.47
(1.464)
|
| Title | Phase 2: Time to Response |
|---|---|
| Description | 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 Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 32 |
| Time to first response |
1.55
(1.363)
|
| Time to best response |
5.60
(3.817)
|
| Title | Phase 2: Overall Survival (OS) |
|---|---|
| Description | 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. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. |
| Arm/Group Title | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone |
|---|---|
| Arm/Group Description | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. |
| Measure Participants | 32 |
| Median (95% Confidence Interval) [Months] |
NA
|
Adverse Events
| Time Frame | Screening to End of the study (Up to 3 years) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | |||||
| Arm/Group Description | Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days. | |||||
All Cause Mortality |
||||||||||
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | 2/3 (66.7%) | 2/4 (50%) | 2/3 (66.7%) | 16/32 (50%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Neutropenia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Cardiac disorders | ||||||||||
| Atrial Fibrillation | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Endocrine disorders | ||||||||||
| Steroid Withdrawal Syndrome | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Eye disorders | ||||||||||
| Retinal Artery Thrombosis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Vitreous Detachment | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Pain | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Diarrhoea | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| General disorders | ||||||||||
| Pyrexia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Infections and infestations | ||||||||||
| Bronchitis | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Gastroenteritis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Lower Respiratory Tract Infection | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Nasopharyngitis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Pneumonia | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Pneumonia Viral | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Upper Respiratory Tract Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Urinary Tract Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Viral Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Pelvic Fracture | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Spinal Fracture | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Investigations | ||||||||||
| Influenza A Virus Test Positive | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back Pain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Osteonecrosis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Adenocarcinoma Gastric | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Nervous system disorders | ||||||||||
| Cerebral Infarction | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Cerebrovascular Accident | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Syncope | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Laryngeal Oedema | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Pulmonary Embolism | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 3/3 (100%) | 31/32 (96.9%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/3 (0%) | 2/3 (66.7%) | 0/4 (0%) | 1/3 (33.3%) | 8/32 (25%) | |||||
| Leukocytosis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Leukopenia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 7/32 (21.9%) | |||||
| Lymphopenia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 4/32 (12.5%) | |||||
| Neutropenia | 3/3 (100%) | 1/3 (33.3%) | 4/4 (100%) | 2/3 (66.7%) | 27/32 (84.4%) | |||||
| Thrombocytopenia | 1/3 (33.3%) | 2/3 (66.7%) | 2/4 (50%) | 0/3 (0%) | 10/32 (31.3%) | |||||
| Cardiac disorders | ||||||||||
| Atrial Fibrillation | 2/3 (66.7%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Bradycardia | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Palpitations | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Supraventricular Tachycardia | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Tinnitus | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Vertigo | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Endocrine disorders | ||||||||||
| Pituitary-Dependent Cushing's Syndrome | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Steroid Withdrawal Syndrome | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Eye disorders | ||||||||||
| Cataract | 0/3 (0%) | 3/3 (100%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Glaucoma | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Lacrimation Increased | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Retinal Artery Thrombosis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Vision Blurred | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Discomfort | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Abdominal Pain | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Abdominal Pain Upper | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Constipation | 3/3 (100%) | 3/3 (100%) | 1/4 (25%) | 1/3 (33.3%) | 6/32 (18.8%) | |||||
| Diarrhoea | 2/3 (66.7%) | 3/3 (100%) | 3/4 (75%) | 1/3 (33.3%) | 14/32 (43.8%) | |||||
| Dyspepsia | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Faeces Discoloured | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Gastrooesophageal Reflux Disease | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Haemorrhoids | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Hypoaesthesia Oral | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Mouth Ulceration | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Nausea | 1/3 (33.3%) | 2/3 (66.7%) | 2/4 (50%) | 0/3 (0%) | 9/32 (28.1%) | |||||
| Tongue Blistering | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Toothache | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Vomiting | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 4/32 (12.5%) | |||||
| General disorders | ||||||||||
| Application Site Erythema | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Asthenia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 4/32 (12.5%) | |||||
| Chest Pain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Facial Pain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Fatigue | 3/3 (100%) | 0/3 (0%) | 4/4 (100%) | 1/3 (33.3%) | 11/32 (34.4%) | |||||
| Inflammation | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Influenza Like Illness | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Oedema | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 1/3 (33.3%) | 2/32 (6.3%) | |||||
| Oedema Peripheral | 2/3 (66.7%) | 0/3 (0%) | 1/4 (25%) | 3/3 (100%) | 8/32 (25%) | |||||
| Pain | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Peripheral Swelling | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Pyrexia | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 8/32 (25%) | |||||
| Immune system disorders | ||||||||||
| Hypogammaglobulinaemia | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Immune System Disorder | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Infections and infestations | ||||||||||
| Bronchitis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 2/3 (66.7%) | 6/32 (18.8%) | |||||
| Cellulitis | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Conjunctivitis | 0/3 (0%) | 2/3 (66.7%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Cystitis | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Diarrhoea Infectious | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Fungal Skin Infection | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Gastroenteritis | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Herpes Zoster | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Influenza | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Lower Respiratory Tract Infection | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Lower Respiratory Tract Infection Viral | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Lung Infection | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Nasopharyngitis | 1/3 (33.3%) | 2/3 (66.7%) | 3/4 (75%) | 2/3 (66.7%) | 6/32 (18.8%) | |||||
| Oral Candidiasis | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Oral Herpes | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Oral Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Pharyngitis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 4/32 (12.5%) | |||||
| Pneumonia | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 0/3 (0%) | 0/32 (0%) | |||||
| Postoperative Wound Infection | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Respiratory Tract Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Rhinitis | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 5/32 (15.6%) | |||||
| Sinusitis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Tooth Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Upper Respiratory Tract Infection | 1/3 (33.3%) | 2/3 (66.7%) | 2/4 (50%) | 0/3 (0%) | 7/32 (21.9%) | |||||
| Urinary Tract Infection | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Viral Infection | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Viral Upper Respiratory Tract Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Vulvovaginal Mycotic Infection | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Clavicle Fracture | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Contusion | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Limb Injury | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Pelvic Fracture | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Investigations | ||||||||||
| Alanine Aminotransferase Increased | 2/3 (66.7%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Aspartate Aminotransferase Increased | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Blood Alkaline Phosphatase Increased | 0/3 (0%) | 2/3 (66.7%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Blood Creatine Phosphokinase Increased | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Blood Lactate Dehydrogenase Increased | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Blood Phosphorus Decreased | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Blood Pressure Increased | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| C-Reactive Protein Increased | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Creatinine Renal Clearance Decreased | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Electrocardiogram QT Prolonged | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Weight Decreased | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased Appetite | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Hyperglycaemia | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Hyperuricaemia | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Hypocalcaemia | 1/3 (33.3%) | 2/3 (66.7%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Hypokalaemia | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 2/32 (6.3%) | |||||
| Hypomagnesaemia | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Hypophosphataemia | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Arthritis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Back Pain | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 6/32 (18.8%) | |||||
| Bone Pain | 1/3 (33.3%) | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 6/32 (18.8%) | |||||
| Gouty Arthritis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Joint Contracture | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Muscle Spasms | 1/3 (33.3%) | 3/3 (100%) | 3/4 (75%) | 3/3 (100%) | 14/32 (43.8%) | |||||
| Muscular Weakness | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Musculoskeletal Chest Pain | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Musculoskeletal Pain | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Myalgia | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Myopathy | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Osteonecrosis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Osteonecrosis of Jaw | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Pain in Extremity | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 4/32 (12.5%) | |||||
| Pain in Jaw | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Tendonitis | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Nervous system disorders | ||||||||||
| Dizziness | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Dizziness Postural | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Dysgeusia | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Headache | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 1/3 (33.3%) | 5/32 (15.6%) | |||||
| Paraesthesia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 2/32 (6.3%) | |||||
| Peripheral Sensory Neuropathy | 1/3 (33.3%) | 1/3 (33.3%) | 2/4 (50%) | 1/3 (33.3%) | 7/32 (21.9%) | |||||
| Post Herpetic Neuralgia | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Sciatica | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Tremor | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Visual Field Defect | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Agitation | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Depressed Mood | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Depression | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Disinhibition | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Insomnia | 1/3 (33.3%) | 2/3 (66.7%) | 3/4 (75%) | 0/3 (0%) | 5/32 (15.6%) | |||||
| Mood Altered | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Renal and urinary disorders | ||||||||||
| Dysuria | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Nocturia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Pollakiuria | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Polyuria | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Renal Impairment | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Urinary Retention | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Allergic Bronchitis | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Bronchospasm | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/32 (3.1%) | |||||
| Cough | 0/3 (0%) | 1/3 (33.3%) | 2/4 (50%) | 1/3 (33.3%) | 16/32 (50%) | |||||
| Dry Throat | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Dysphonia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Dyspnoea | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 1/3 (33.3%) | 3/32 (9.4%) | |||||
| Dyspnoea Exertional | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Epistaxis | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Nasal Congestion | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Oropharyngeal Pain | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Productive Cough | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Rhinitis Allergic | 0/3 (0%) | 2/3 (66.7%) | 0/4 (0%) | 1/3 (33.3%) | 4/32 (12.5%) | |||||
| Wheezing | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermal Cyst | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Ecchymosis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Eczema | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Hyperhidrosis | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 3/32 (9.4%) | |||||
| Pruritus | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Purpura | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/32 (0%) | |||||
| Rash | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
| Rash Generalised | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Skin Disorder | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/32 (0%) | |||||
| Skin Fragility | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Skin Lesion | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/32 (3.1%) | |||||
| Skin Ulcer | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/32 (0%) | |||||
| Vascular disorders | ||||||||||
| Flushing | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/32 (6.3%) | |||||
| Hypertension | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 9/32 (28.1%) | |||||
| Hypotension | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/32 (9.4%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Senior Director, Clinical Research |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01615029
Other Study ID Numbers:
- CR101391
- GEN503
- DARA-GEN503
- 2011-005709-62
First Posted:
Jun 8, 2012
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022