DARZALEX: A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03023423
Collaborator
Genentech, Inc. (Industry)
100
47
2
33.1
2.1
0.1
Study Details
Study Description
Brief Summary
The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
This randomized (study medication assigned to participants by chance), multicenter study will provide study treatment (atezolizumab alone or atezolizumab+daratumumab) to participants with previously treated advanced or metastatic NSCLC to assess the anti-tumor activity and safety. Participants who receive atezolizumab treatment with confirmed disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be eligible to crossover to treatment (atezolizumab + daratumumab) if they meet crossover eligibility criteria. It is expected that 100 participants will enroll in the study including 6 participants in the safety run in phase. Data Monitoring Committee (DMC) will review ongoing data, and may formulate recommendations on study conduct, including expansion of enrollment of some PD-L1 subgroups, resulting in greater than 96 participants. The participants in the safety run in phase will be administered the combination of daratumumab and atezolizumab to determine the safety and tolerability that will be evaluated by the Safety Evaluation Team (SET) for dose limiting toxicity before the random assignment of participants in a 1:1 ratio in 2 treatment arms. The study consists of 3 phases: Screening Phase (up to 28 days), Treatment Phase and Post-Treatment Follow-up Phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study [the study end is approximately 6 to 12 months after that last participant is enrolled]. Participants will undergo tumor assessments (RECIST 1.1), immunogenicity, pharmacokinetics, biomarkers and safety evaluations (adverse events, laboratory tests, electrocardiogram [ECGs], vital sign measurements, physical examinations, Eastern Cooperative Oncology Group [ECOG] performance status score) over the time.
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date
:
Dec 23, 2016
Actual Primary Completion Date
:
May 17, 2018
Actual Study Completion Date
:
Sep 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm A: Atezolizumab Participants in Treatment Arm A will receive Atezolizumab 1,200 milligram (mg) intravenously (IV) on Day 1 of every 21-day cycle. Participants with confirmed disease progression based on RECIST 1.1 may cross over to Arm B and receive daratumumab and atezolizumab, provided crossover eligibility criteria are met. |
Drug: Atezolizumab
Participants will receive atezolizumab 1200 mg intravenously.
|
| Experimental: Treatment Arm B: Atezolizumab and Daratumumab Participants will receive daratumumab 16 milligram per kilogram [mg/kg] (Safety Run-in and Treatment Arm B) Intravenously (IV) weekly for 3 cycles (Day 1, 8 and 15), and Day 1 of every 21-day cycle thereafter. Atezolizumab will be administered at 1200 mg IV on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. |
Drug: Atezolizumab
Participants will receive atezolizumab 1200 mg intravenously.
Drug: Daratumumab
Participants will receive daratumumab 16 mg/kg intravenously.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Overall Response Rate (ORR) [Up to 1.5 years]
ORR was defined as the percentage of participants with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Criteria for CR: Disappearance of all target lesions; all lymph nodes must be of non-pathological in size (less than [<]10 millimeter [mm] short axis; normalization of tumor marker level. Criteria for PR: greater than or equal to (>=)30 percent (%) decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Overall Response (OR) = CR + PR. The outcome measure (OM) was planned to be reported for participants based on their initial assignment to Randomized Phase: Atezolizumab'.
Secondary Outcome Measures
- Number of Participants With Adverse Events [Up to 1.5 years]
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Crossover participants were counted twice (in 'Randomized Phase: Atezo arm' and in 'Randomized Phase: Atezo Crossed Over to Dara + Atezo') for safety analysis. For cross-over participants, AEs after initiation of cross-over treatment were summarized separately in the crossover arm, however, AEs occurred before crossover treatment were included in 'Randomized Phase: Atezolizumab arm'.
- Duration of Response (DoR) [Up to 1.5 years]
Duration of response was defined as duration from date of initial documentation of disease response to date of first objectively documented evidence of recurrence or progressive disease (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Clinical Benefit Rate [Up to 1.5 years]
Clinical benefit rate was defined as percentage of participants who achieved disease control (CR, PR, or SD). RECIST 1.1 Criteria for CR: Disappearance of all target lesions; all lymph nodes of non-pathological in size (<10 mm short axis); normalization of tumor marker level. Criteria for PR: >=30 % decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Criteria for SD: <30% decrease in sum of diameters of all target lesions compared with baseline and <20% increase compared with nadir, in absence of new lesions or unequivocal progression of nontarget lesions. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Progression-Free Survival (PFS) [Up to 1.5 years]
PFS was defined as the duration from the date of randomization until the first documented disease progression (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Overall Survival (OS) [Up to 1.5 years]
Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Daratumumab Serum Concentration [Cycle 1 Day 1 (C1D1):predose and postdose; C2D1 and C3D1:predose; C3D15: predose and postdose; C4D1: predose and postdose; C8D1: predose and postdose; C12D1: predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years)]
Daratumumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Atezolizumab Serum Concentration [C1D1:predose and postdose; C1D2:predose and postdose; C2D1, C3D1:predose; C3D15:predose and postdose; C4D1:predose and postdose; C8D1:predose and postdose; C12D1:predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years)]
Atezolizumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Number of Participants With Anti-Daratumumab Antibodies [Up to 1.5 years]
Number of participants with antibodies to daratumumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
- Number of Participants With Anti-Atezolizumab Antibodies [Up to 1.5 years]
Number of participants with antibodies to atezolizumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIb or greater)
-
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
-
Tumor cell programmed death-ligand 1 (PD-L1) score of tumor cells (TC)1-3 and immune cell PD-L1 score of tumor-infiltrating immune cells (IC)0-3 as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained after the last line of therapy
-
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration
Inclusion Criteria for Crossover:
-
Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1
-
Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over. If not clinically feasible, discussion with Sponsor is required
-
The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
Exclusion Criteria:
- Received any of the following prescribed medications or therapies in the past:
-
Anti-cluster of differentiation(CD)38 therapy, including daratumumab
-
CD137 agonists, immune checkpoint inhibitors including but not limited to CTLA-4, anti-PD-1, and anti-PD-L1 therapies
-
Known to be seropositive for human immunodeficiency virus (HIV)
-
Prior allogeneic bone marrow transplantation or solid organ transplant
-
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
-
Active hepatitis B, defined by a positive test for hepatitis B surface antigen [HBsAg] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc], regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection
Exclusion Criteria for Crossover:
-
Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
-
Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing over
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda | California | United States | ||
| 2 | Whittier | California | United States | ||
| 3 | Newark | Delaware | United States | ||
| 4 | Deerfield Beach | Florida | United States | ||
| 5 | Fort Lauderdale | Florida | United States | ||
| 6 | Orlando | Florida | United States | ||
| 7 | Tampa | Florida | United States | ||
| 8 | Athens | Georgia | United States | ||
| 9 | Atlanta | Georgia | United States | ||
| 10 | New Orleans | Louisiana | United States | ||
| 11 | Bethesda | Maryland | United States | ||
| 12 | Oklahoma City | Oklahoma | United States | ||
| 13 | Chattanooga | Tennessee | United States | ||
| 14 | Knoxville | Tennessee | United States | ||
| 15 | Nashville | Tennessee | United States | ||
| 16 | Spokane | Washington | United States | ||
| 17 | Bordeaux | France | |||
| 18 | Boulogne Billancourt | France | |||
| 19 | Caen Cedex | France | |||
| 20 | Creteil | France | |||
| 21 | Haut-Rhin | France | |||
| 22 | Montpellier | France | |||
| 23 | Nancy | France | |||
| 24 | Paris | France | |||
| 25 | Rennes cedex 9 | France | |||
| 26 | Rouen | France | |||
| 27 | Suresnes | France | |||
| 28 | Vandoeuvre les Nancy | France | |||
| 29 | Budapest | Hungary | |||
| 30 | Szekesfehervar | Hungary | |||
| 31 | Tatabanya | Hungary | |||
| 32 | Lodz | Poland | |||
| 33 | Otwock | Poland | |||
| 34 | Wieliszew | Poland | |||
| 35 | Barcelona | Spain | |||
| 36 | Elche | Spain | |||
| 37 | Jaén | Spain | |||
| 38 | Leganés | Spain | |||
| 39 | Madrid | Spain | |||
| 40 | Murcia | Spain | |||
| 41 | Málaga | Spain | |||
| 42 | Palma de Mallorca | Spain | |||
| 43 | Pozuelo de Alarcón | Spain | |||
| 44 | San Sebastián | Spain | |||
| 45 | Sótano | Spain | |||
| 46 | Valencia | Spain | |||
| 47 | Zaragoza | Spain |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Genentech, Inc.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT03023423
Other Study ID Numbers:
- CR108256
- 2016-002579-83
- 54767414LUC2001
First Posted:
Jan 18, 2017
Last Update Posted:
Nov 20, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 100 participants were enrolled in the study (7 in phase 1b [safety run-in phase], and 93 in Phase 2 [randomized phase]). Among them, 99 participants (7 in phase 1b [safety run-in phase], and 92 in phase 2 [randomized phase]) were randomized as 1 participant was randomized after the clinical cutoff date (17-May-2018). |
| Arm/Group Title | Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|---|
| Arm/Group Description | Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Period Title: Overall Study | |||
| STARTED | 7 | 46 | 46 |
| Treated | 7 | 44 | 44 |
| Crossover From Atezo to Dara + Atezo | 0 | 8 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 7 | 46 | 46 |
Baseline Characteristics
| Arm/Group Title | Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Total of all reporting groups |
| Overall Participants | 7 | 46 | 46 | 99 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
61
(9.73)
|
61.7
(10.05)
|
63.2
(10.76)
|
62.3
(10.29)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
42.9%
|
18
39.1%
|
8
17.4%
|
29
29.3%
|
| Male |
4
57.1%
|
28
60.9%
|
38
82.6%
|
70
70.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
1
2.2%
|
0
0%
|
1
1%
|
| Not Hispanic or Latino |
7
100%
|
36
78.3%
|
40
87%
|
83
83.8%
|
| Unknown or Not Reported |
0
0%
|
9
19.6%
|
6
13%
|
15
15.2%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
7
100%
|
35
76.1%
|
41
89.1%
|
83
83.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
11
23.9%
|
5
10.9%
|
16
16.2%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Other |
0
0%
|
11
23.9%
|
6
13%
|
17
17.2%
|
| White Non-Hispanic |
7
100%
|
35
76.1%
|
40
87%
|
82
82.8%
|
| Region of Enrollment (Count of Participants) | ||||
| FRANCE |
0
0%
|
10
21.7%
|
6
13%
|
16
16.2%
|
| HUNGARY |
0
0%
|
8
17.4%
|
7
15.2%
|
15
15.2%
|
| SPAIN |
3
42.9%
|
19
41.3%
|
27
58.7%
|
49
49.5%
|
| UNITED STATES |
4
57.1%
|
9
19.6%
|
6
13%
|
19
19.2%
|
| Time from initial diagnosis (months) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [months] |
10.3
(9.29)
|
18.8
(20.89)
|
17.6
(14.17)
|
17.6
(17.37)
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | ||||
| ECOG Score 0 |
3
42.9%
|
19
41.3%
|
12
26.1%
|
34
34.3%
|
| ECOG Score 1 |
4
57.1%
|
27
58.7%
|
33
71.7%
|
64
64.6%
|
| ECOG Score 2 |
0
0%
|
0
0%
|
1
2.2%
|
1
1%
|
Outcome Measures
| Title | Percentage of Participants With Overall Response Rate (ORR) |
|---|---|
| Description | ORR was defined as the percentage of participants with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Criteria for CR: Disappearance of all target lesions; all lymph nodes must be of non-pathological in size (less than [<]10 millimeter [mm] short axis; normalization of tumor marker level. Criteria for PR: greater than or equal to (>=)30 percent (%) decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Overall Response (OR) = CR + PR. The outcome measure (OM) was planned to be reported for participants based on their initial assignment to Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) analysis set included all participants who had entered the Randomized phase of the study. |
| Arm/Group Title | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 46 | 46 |
| Number (95% Confidence Interval) [Percentage of participants] |
13.0
185.7%
|
4.3
9.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Randomized Phase: Atezolizumab, Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 1.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Crossover participants were counted twice (in 'Randomized Phase: Atezo arm' and in 'Randomized Phase: Atezo Crossed Over to Dara + Atezo') for safety analysis. For cross-over participants, AEs after initiation of cross-over treatment were summarized separately in the crossover arm, however, AEs occurred before crossover treatment were included in 'Randomized Phase: Atezolizumab arm'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all participants who had received at least 1 administration of any study medication. |
| Arm/Group Title | Safety Run-in: Atezolizumab + Daratumumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezo Crossed Over to Dara + Atezo |
|---|---|---|---|---|
| Arm/Group Description | Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants who crossed over from Atezolizumab arm (Randomized Phase) to Daratumumab + Atezolizumab arm (Randomized Phase) received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol defined treatment discontinuation criteria. |
| Measure Participants | 7 | 44 | 44 | 8 |
| Number [Participants] |
7
100%
|
42
91.3%
|
44
95.7%
|
8
8.1%
|
| Title | Duration of Response (DoR) |
|---|---|
| Description | Duration of response was defined as duration from date of initial documentation of disease response to date of first objectively documented evidence of recurrence or progressive disease (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who had entered the Randomized phase of the study. Here, N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. |
| Arm/Group Title | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 6 | 2 |
| Median (95% Confidence Interval) [Months] |
5.8
|
2.9
|
| Title | Clinical Benefit Rate |
|---|---|
| Description | Clinical benefit rate was defined as percentage of participants who achieved disease control (CR, PR, or SD). RECIST 1.1 Criteria for CR: Disappearance of all target lesions; all lymph nodes of non-pathological in size (<10 mm short axis); normalization of tumor marker level. Criteria for PR: >=30 % decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Criteria for SD: <30% decrease in sum of diameters of all target lesions compared with baseline and <20% increase compared with nadir, in absence of new lesions or unequivocal progression of nontarget lesions. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who had entered the Randomized phase of the study. |
| Arm/Group Title | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 46 | 46 |
| Number (95% Confidence Interval) [Percentage of Participants] |
43.5
621.4%
|
52.2
113.5%
|
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | PFS was defined as the duration from the date of randomization until the first documented disease progression (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who had entered the Randomized phase of the study. |
| Arm/Group Title | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 46 | 46 |
| Median (95% Confidence Interval) [Months] |
1.48
|
1.68
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who had entered the Randomized phase of the study. |
| Arm/Group Title | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 46 | 46 |
| Median (95% Confidence Interval) [Months] |
NA
|
7.13
|
| Title | Daratumumab Serum Concentration |
|---|---|
| Description | Daratumumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Cycle 1 Day 1 (C1D1):predose and postdose; C2D1 and C3D1:predose; C3D15: predose and postdose; C4D1: predose and postdose; C8D1: predose and postdose; C12D1: predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK)-evaluable analysis set included all participants who had received at least 1 dose of daratumumab or atezolizumab and had at least 1 postinfusion sample collected. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point. |
| Arm/Group Title | Safety Run-in: Atezolizumab + Daratumumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 7 | 43 |
| Cycle 1 Day 1 Predose |
0.00
(0.000)
|
0.00
(0.000)
|
| Cycle 1 Day 1 Postdose |
417.13
(141.626)
|
296.12
(85.660)
|
| Cycle 2 Day 1 Predose |
393.95
(139.480)
|
278.42
(89.340)
|
| Cycle 3 Day 1 Predose |
740.17
(99.515)
|
487.65
(124.935)
|
| Cycle 3 Day 15 Predose |
843.22
(156.792)
|
552.79
(180.549)
|
| Cycle 3 Day 15 Postdose |
1088.73
(282.349)
|
827.72
(266.085)
|
| Cycle 4 Day 1 Predose |
899.90
(123.305)
|
574.81
(181.193)
|
| Cycle 4 Day 1 Postdose |
1416.40
(353.415)
|
856.30
(244.698)
|
| Cycle 8 Day 1 Predose |
254.87
(NA)
|
288.84
(177.187)
|
| Cycle 8 Day 1 Postdose |
824.64
(NA)
|
617.21
(239.962)
|
| Cycle 12 Day 1 Predose |
260.21
(17.163)
|
|
| End of Treatment |
405.14
(242.189)
|
187.75
(110.531)
|
| Post Last Dose |
41.84
(23.082)
|
112.63
(115.727)
|
| Title | Atezolizumab Serum Concentration |
|---|---|
| Description | Atezolizumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | C1D1:predose and postdose; C1D2:predose and postdose; C2D1, C3D1:predose; C3D15:predose and postdose; C4D1:predose and postdose; C8D1:predose and postdose; C12D1:predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK-evaluable analysis set: all participants who received at least 1 dose of daratumumab/atezolizumab and had at least 1 postinfusion sample collected. Here N (number of participants analyzed): participants evaluable for this outcome measure, and n (number of participants analyzed): participants evaluable for this outcome measure at given timepoint. |
| Arm/Group Title | Safety Run-in: Atezolizumab + Daratumumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|---|
| Arm/Group Description | Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 7 | 39 | 39 |
| Cycle 1 Day 1 Predose |
0.00
(0.000)
|
0.00
(0.000)
|
|
| Cycle 1 Day 1 Postdose |
396.51
(103.196)
|
440.00
(93.145)
|
|
| Cycle 1 Day 2 Predose |
0.00
(0.000)
|
0.00
(0.000)
|
|
| Cycle 1 Day 2 Postdose |
362.14
(43.434)
|
343.82
(135.476)
|
|
| Cycle 2 Day 1 Predose |
91.16
(15.305)
|
78.85
(30.575)
|
81.90
(20.021)
|
| Cycle 3 Day 1 Predose |
176.50
(33.234)
|
117.61
(33.227)
|
123.51
(31.882)
|
| Cycle 4 Day 1 Predose |
166.50
(37.477)
|
145.64
(37.323)
|
157.79
(37.819)
|
| Cycle 4 Day 1 Postdose |
612.25
(81.578)
|
539.24
(116.291)
|
482.33
(139.879)
|
| Cycle 8 Day 1 Predose |
158.23
(77.778)
|
||
| Cycle 8 Day 1 Postdose |
527.50
(213.492)
|
515.25
(214.177)
|
|
| Cycle 12 Day 1 Predose |
183.00
(NA)
|
248.00
(NA)
|
|
| End of Treatment |
136.43
(73.002)
|
129.55
(79.720)
|
141.62
(71.756)
|
| Post Last Dose |
33.10
(NA)
|
13.17
(8.386)
|
115.10
(146.937)
|
| Title | Number of Participants With Anti-Daratumumab Antibodies |
|---|---|
| Description | Number of participants with antibodies to daratumumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The immunogenicity-evaluable analysis set included all participants who received at least 1 dose of atezolizumab or daratumumab and had appropriate samples for detection of antibodies to atezolizumab or daratumumab. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Safety Run-in: Atezolizumab + Daratumumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|
| Arm/Group Description | Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 7 | 37 |
| Number [Participants] |
0
0%
|
0
0%
|
| Title | Number of Participants With Anti-Atezolizumab Antibodies |
|---|---|
| Description | Number of participants with antibodies to atezolizumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'. |
| Time Frame | Up to 1.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The immunogenicity-evaluable analysis set included all participants who received at least 1 dose of atezolizumab or daratumumab and had appropriate samples for detection of antibodies to atezolizumab or daratumumab. |
| Arm/Group Title | Safety Run-in: Atezolizumab + Daratumumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab |
|---|---|---|---|
| Arm/Group Description | Participants received daratumumab 16 milligram per kilogram (mg/kg) Intravenously (IV) weekly for first 3 cycles and every 3 weeks for all cycles thereafter along with atezolizumab IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. |
| Measure Participants | 7 | 39 | 38 |
| Number [Participants] |
0
0%
|
6
13%
|
5
10.9%
|
Adverse Events
| Time Frame | Up to 1.5 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety analysis set included participants who received at least 1 administration of any study medication. Crossover participants were counted twice (in 'Randomized Phase: Atezo arm' and 'Randomized Phase: Atezo Crossed Over to Dara + Atezo') for safety analysis. For cross-over participants, adverse events (AEs) after initiation of cross-over treatment summarized separately in crossover arm, however, AEs occurred before crossover treatment were included in 'Randomized Phase: Atezolizumab arm'. | |||||||
| Arm/Group Title | Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezo Crossed Over to Dara + Atezo | ||||
| Arm/Group Description | Participants received daratumumab (Dara) 16 milligram per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab (Atezo) IV at a dose of 1200 milligram (mg) on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received atezolizumab IV at a dose of 1200 milligram (mg) on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | Participants who crossed over from Atezolizumab arm (Randomized Phase) to Daratumumab + Atezolizumab arm (Randomized Phase) received daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 for first 3 cycles and then on Day 1 of each 21-day cycle thereafter along with atezolizumab IV at a dose of 1200 mg on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter until disease progression, unacceptable toxicity or other protocol-defined treatment discontinuation criteria. | ||||
All Cause Mortality |
||||||||
| Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezo Crossed Over to Dara + Atezo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/7 (71.4%) | 9/44 (20.5%) | 20/44 (45.5%) | 3/8 (37.5%) | ||||
Serious Adverse Events |
||||||||
| Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezo Crossed Over to Dara + Atezo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/7 (57.1%) | 15/44 (34.1%) | 21/44 (47.7%) | 3/8 (37.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Cardiac disorders | ||||||||
| Atrial Fibrillation | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Cardiac Failure | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Cardio-Respiratory Arrest | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Myocardial Infarction | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pericardial Effusion | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal Pain | 0/7 (0%) | 2/44 (4.5%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Colitis | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Nausea | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Rectal Haemorrhage | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| General disorders | ||||||||
| General Physical Health Deterioration | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Non-Cardiac Chest Pain | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Sudden Death | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Fatigue | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Pyrexia | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Oral Infection | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pneumonia | 0/7 (0%) | 3/44 (6.8%) | 3/44 (6.8%) | 1/8 (12.5%) | ||||
| Respiratory Tract Infection | 0/7 (0%) | 1/44 (2.3%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Superinfection | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Urinary Tract Infection | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Femur Fracture | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Back Pain | 1/7 (14.3%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pain in Extremity | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Nervous system disorders | ||||||||
| Cerebrovascular Accident | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Transient Ischaemic Attack | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Vocal Cord Paralysis | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Acute Kidney Injury | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Bronchial Fistula | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Bronchial Obstruction | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Dyspnoea | 1/7 (14.3%) | 0/44 (0%) | 6/44 (13.6%) | 2/8 (25%) | ||||
| Haemoptysis | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Painful Respiration | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pleural Effusion | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pneumonitis | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Pneumothorax | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pulmonary Embolism | 0/7 (0%) | 2/44 (4.5%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Respiratory Failure | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Safety Run-in Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezolizumab | Randomized Phase: Daratumumab + Atezolizumab | Randomized Phase: Atezo Crossed Over to Dara + Atezo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/7 (100%) | 41/44 (93.2%) | 41/44 (93.2%) | 8/8 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/7 (14.3%) | 6/44 (13.6%) | 7/44 (15.9%) | 1/8 (12.5%) | ||||
| Deficiency Anaemia | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Leukopenia | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Lymphopenia | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Thrombocytopenia | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Cardiac disorders | ||||||||
| Sinus Tachycardia | 2/7 (28.6%) | 0/44 (0%) | 2/44 (4.5%) | 1/8 (12.5%) | ||||
| Tachycardia | 1/7 (14.3%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Ventricular Extrasystoles | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pericardial Effusion | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Sinus Bradycardia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Endocrine disorders | ||||||||
| Hyperthyroidism | 0/7 (0%) | 3/44 (6.8%) | 0/44 (0%) | 0/8 (0%) | ||||
| Hypothyroidism | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 1/8 (12.5%) | ||||
| Eye disorders | ||||||||
| Dry Eye | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Diplopia | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Eye Irritation | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Vision Blurred | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Visual Acuity Reduced | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal Pain | 2/7 (28.6%) | 0/44 (0%) | 6/44 (13.6%) | 0/8 (0%) | ||||
| Constipation | 2/7 (28.6%) | 5/44 (11.4%) | 4/44 (9.1%) | 1/8 (12.5%) | ||||
| Diarrhoea | 1/7 (14.3%) | 4/44 (9.1%) | 4/44 (9.1%) | 0/8 (0%) | ||||
| Dysphagia | 0/7 (0%) | 1/44 (2.3%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Nausea | 3/7 (42.9%) | 8/44 (18.2%) | 7/44 (15.9%) | 2/8 (25%) | ||||
| Stomatitis | 1/7 (14.3%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Vomiting | 1/7 (14.3%) | 3/44 (6.8%) | 6/44 (13.6%) | 1/8 (12.5%) | ||||
| Abdominal Discomfort | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Abdominal Pain Upper | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Colitis | 0/7 (0%) | 2/44 (4.5%) | 0/44 (0%) | 0/8 (0%) | ||||
| Dry Mouth | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Flatulence | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Gastrooesophageal Reflux Disease | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Odynophagia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Toothache | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| General disorders | ||||||||
| Asthenia | 3/7 (42.9%) | 15/44 (34.1%) | 14/44 (31.8%) | 2/8 (25%) | ||||
| Chest Discomfort | 2/7 (28.6%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Chest Pain | 0/7 (0%) | 3/44 (6.8%) | 3/44 (6.8%) | 2/8 (25%) | ||||
| Chills | 1/7 (14.3%) | 0/44 (0%) | 3/44 (6.8%) | 1/8 (12.5%) | ||||
| Fatigue | 3/7 (42.9%) | 7/44 (15.9%) | 9/44 (20.5%) | 2/8 (25%) | ||||
| Malaise | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pyrexia | 2/7 (28.6%) | 5/44 (11.4%) | 4/44 (9.1%) | 2/8 (25%) | ||||
| General Physical Health Deterioration | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Hypothermia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Localised Oedema | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Mucosal Inflammation | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Non-Cardiac Chest Pain | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 1/8 (12.5%) | ||||
| Oedema Peripheral | 0/7 (0%) | 2/44 (4.5%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Pain | 0/7 (0%) | 2/44 (4.5%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Secretion Discharge | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Temperature Intolerance | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Immune system disorders | ||||||||
| Hypersensitivity | 0/7 (0%) | 0/44 (0%) | 4/44 (9.1%) | 0/8 (0%) | ||||
| Drug Hypersensitivity | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Infections and infestations | ||||||||
| Respiratory Tract Infection | 0/7 (0%) | 0/44 (0%) | 5/44 (11.4%) | 1/8 (12.5%) | ||||
| Bronchitis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Furuncle | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Influenza | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Nasopharyngitis | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Oral Herpes | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Rhinitis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Sinusitis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Tooth Infection | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Upper Respiratory Tract Infection | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Urinary Tract Infection | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Fall | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Buttock Injury | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Investigations | ||||||||
| Weight Decreased | 0/7 (0%) | 1/44 (2.3%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Alanine Aminotransferase Increased | 0/7 (0%) | 2/44 (4.5%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Aspartate Aminotransferase Increased | 0/7 (0%) | 2/44 (4.5%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Blood Alkaline Phosphatase Increased | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Blood Lactate Dehydrogenase Increased | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Eastern Cooperative Oncology Group Performance Status Worsened | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Gamma-Glutamyltransferase Increased | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Lipase Increased | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Oxygen Saturation Decreased | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Weight Increased | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased Appetite | 2/7 (28.6%) | 7/44 (15.9%) | 11/44 (25%) | 1/8 (12.5%) | ||||
| Dehydration | 2/7 (28.6%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Hyperglycaemia | 0/7 (0%) | 0/44 (0%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Hypokalaemia | 1/7 (14.3%) | 1/44 (2.3%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Hypoalbuminaemia | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Hypocalcaemia | 0/7 (0%) | 1/44 (2.3%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Hyponatraemia | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/7 (14.3%) | 8/44 (18.2%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Back Pain | 0/7 (0%) | 3/44 (6.8%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Musculoskeletal Chest Pain | 1/7 (14.3%) | 2/44 (4.5%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Myalgia | 1/7 (14.3%) | 5/44 (11.4%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pain in Extremity | 1/7 (14.3%) | 4/44 (9.1%) | 4/44 (9.1%) | 0/8 (0%) | ||||
| Arthritis | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Groin Pain | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Muscle Contracture | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Muscle Spasms | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Muscular Weakness | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Musculoskeletal Discomfort | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Musculoskeletal Pain | 0/7 (0%) | 2/44 (4.5%) | 0/44 (0%) | 0/8 (0%) | ||||
| Neck Pain | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Spinal Pain | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Tumour Pain | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 2/7 (28.6%) | 1/44 (2.3%) | 2/44 (4.5%) | 1/8 (12.5%) | ||||
| Headache | 3/7 (42.9%) | 2/44 (4.5%) | 0/44 (0%) | 2/8 (25%) | ||||
| Paraesthesia | 0/7 (0%) | 3/44 (6.8%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Aphonia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Dysgeusia | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Hypokinesia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Peripheral Sensory Neuropathy | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Sciatica | 0/7 (0%) | 2/44 (4.5%) | 0/44 (0%) | 0/8 (0%) | ||||
| Seizure | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Somnolence | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Tremor | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Psychiatric disorders | ||||||||
| Depression | 1/7 (14.3%) | 0/44 (0%) | 1/44 (2.3%) | 1/8 (12.5%) | ||||
| Insomnia | 1/7 (14.3%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Anxiety | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Nervousness | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Sleep Disorder | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Acute Kidney Injury | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Bladder Spasm | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Haematuria | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Pollakiuria | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Renal Colic | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Renal Failure | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Renal Vein Thrombosis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Urinary Retention | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Gynaecomastia | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Bronchospasm | 0/7 (0%) | 0/44 (0%) | 3/44 (6.8%) | 0/8 (0%) | ||||
| Cough | 1/7 (14.3%) | 10/44 (22.7%) | 16/44 (36.4%) | 3/8 (37.5%) | ||||
| Dry Throat | 1/7 (14.3%) | 0/44 (0%) | 0/44 (0%) | 0/8 (0%) | ||||
| Dyspnoea | 5/7 (71.4%) | 9/44 (20.5%) | 13/44 (29.5%) | 0/8 (0%) | ||||
| Haemoptysis | 0/7 (0%) | 5/44 (11.4%) | 5/44 (11.4%) | 0/8 (0%) | ||||
| Throat Irritation | 0/7 (0%) | 0/44 (0%) | 4/44 (9.1%) | 0/8 (0%) | ||||
| Aspiration | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Dysphonia | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Dyspnoea Exertional | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Laryngeal Oedema | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Nasal Congestion | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 1/8 (12.5%) | ||||
| Oropharyngeal Pain | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Pleural Effusion | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pleurisy | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Pleuritic Pain | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Pneumonitis | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Pneumothorax | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Productive Cough | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Rhinorrhoea | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Sneezing | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Throat Tightness | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Upper-Airway Cough Syndrome | 0/7 (0%) | 0/44 (0%) | 0/44 (0%) | 1/8 (12.5%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 0/7 (0%) | 4/44 (9.1%) | 0/44 (0%) | 2/8 (25%) | ||||
| Rash | 2/7 (28.6%) | 2/44 (4.5%) | 3/44 (6.8%) | 1/8 (12.5%) | ||||
| Dermatitis Acneiform | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Dry Skin | 0/7 (0%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Eczema | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Erythema | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Hair Disorder | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Hyperhidrosis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Night Sweats | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Rash Maculo-Papular | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Rash Papular | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Rash Pruritic | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Skin Lesion | 0/7 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/8 (0%) | ||||
| Urticaria | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Vascular disorders | ||||||||
| Flushing | 1/7 (14.3%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Hypertension | 4/7 (57.1%) | 0/44 (0%) | 4/44 (9.1%) | 0/8 (0%) | ||||
| Hypotension | 0/7 (0%) | 0/44 (0%) | 2/44 (4.5%) | 0/8 (0%) | ||||
| Thrombosis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
| Venous Thrombosis | 0/7 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/8 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring 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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
| Name/Title | Executive Medical Director |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT03023423
Other Study ID Numbers:
- CR108256
- 2016-002579-83
- 54767414LUC2001
First Posted:
Jan 18, 2017
Last Update Posted:
Nov 20, 2019
Last Verified:
Nov 1, 2019