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Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987232
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Extensive-Stage Small-Cell Lung Cancer
Interventions Drug: Carfilzomib
Drug: Carboplatin
Drug: Etoposide
Enrollment 32
Recruitment Details This study was conducted at 17 centers in the United States, Russia, and Canada.
Pre-assignment Details In the phase 1b portion of the study participants were assigned sequentially to escalating doses of carfilzomib given in combination with standard dose carboplatin and etoposide to establish the maximum tolerated dose (MTD). The phase 2 portion of the study was not enrolled.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Hide Arm/Group Description Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Period Title: Overall Study
Started 5 3 3 15 6
Completed 5 3 3 14 6
Not Completed 0 0 0 1 0
Reason Not Completed
Ongoing in Study             0             0             0             1             0
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² Total
Hide Arm/Group Description Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Total of all reporting groups
Overall Number of Baseline Participants 5 3 3 15 6 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
69.2  (13.8) 62.3  (8.5) 59.0  (7.5) 56.9  (9.4) 58.8  (7.9) 59.9  (10.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
< 65 years
2
  40.0%
2
  66.7%
2
  66.7%
14
  93.3%
5
  83.3%
25
  78.1%
≥ 65 years
3
  60.0%
1
  33.3%
1
  33.3%
1
   6.7%
1
  16.7%
7
  21.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
Female
3
  60.0%
2
  66.7%
1
  33.3%
5
  33.3%
1
  16.7%
12
  37.5%
Male
2
  40.0%
1
  33.3%
2
  66.7%
10
  66.7%
5
  83.3%
20
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   3.1%
Not Hispanic or Latino
5
 100.0%
3
 100.0%
3
 100.0%
14
  93.3%
5
  83.3%
30
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   3.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
White
5
 100.0%
3
 100.0%
3
 100.0%
14
  93.3%
6
 100.0%
31
  96.9%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   3.1%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 15 participants 6 participants 32 participants
0 (Fully active)
4
  80.0%
0
   0.0%
1
  33.3%
3
  20.0%
2
  33.3%
10
  31.3%
1 (Restrictive but ambulatory)
1
  20.0%
3
 100.0%
2
  66.7%
12
  80.0%
4
  66.7%
22
  68.8%
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair; 5 = Dead.
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities
Hide Description

The maximum tolerated dose (MTD) was defined as the highest dose level at which < 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as:

  • A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT.
  • Grade 4 neutropenia: absolute neutrophil count (ANC) < 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature > 38.3°C) neutropenia (ANC < 1000 mm³).
  • Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion
  • Grade 4 fatigue lasting ≥ 7 days
  • Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days.
Time Frame First 21-day Cycle
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study treatment.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 5 3 3 15 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
2.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following:

Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated

Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)

Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL

Grade 4 - Life-threatening

Grade 5 - Fatal.

A serious AE is an AE that met one or more of the following criteria:

  • Death
  • Life-threatening
  • Required inpatient hospitalization or prolongation of an existing hospitalization
  • Resulted in persistent or significant disability/incapacity
  • A congenital anomaly/birth defect
  • Important medical events that required medical or surgical intervention to prevent one of the outcomes above.
Time Frame From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study treatment.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 5 3 3 15 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
5
 100.0%
3
 100.0%
3
 100.0%
15
 100.0%
5
  83.3%
Adverse events ≥ grade 3
3
  60.0%
3
 100.0%
2
  66.7%
13
  86.7%
4
  66.7%
Serious adverse events
1
  20.0%
1
  33.3%
1
  33.3%
7
  46.7%
2
  33.3%
AEs leading to disocontinuation of study drug
1
  20.0%
0
   0.0%
0
   0.0%
3
  20.0%
1
  16.7%
Fatal adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
3.Secondary Outcome
Title Overall Survival (OS) - Phase 2
Hide Description Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in phase 2
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Maximum Plasma Concentration - Phase 2
Hide Description Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time Frame Cycle 1 Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 participants
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time of Maximum Plasma Concentration - Phase 2
Hide Description Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time Frame Cycle 1 Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 participants
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Area Under Plasma Concentration-Time Curve - Phase 2
Hide Description Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time Frame Cycle 1 Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 participants
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Progression-free Survival
Hide Description

Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions.

Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.

Time Frame From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study treatment.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 5 3 3 15 6 32
Median (95% Confidence Interval)
Unit of Measure: months
4.0
(2.8 to 6.7)
6.4
(6.2 to 6.8)
7.0
(4.0 to 7.0)
2.9
(2.5 to 5.4)
3.8
(1.1 to 6.3)
4.4
(2.8 to 5.6)
8.Other Pre-specified Outcome
Title Overall Response Rate
Hide Description

The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria.

CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.

Time Frame From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study treatment.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target area AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 5 3 3 15 6 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(14.7 to 94.7)
100.0
(29.2 to 100.0)
66.7
(9.4 to 99.2)
33.3
(11.8 to 61.6)
33.3
(4.3 to 77.7)
46.9
(29.1 to 65.3)
9.Other Pre-specified Outcome
Title Duration of Response
Hide Description

Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.

DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis.

Time Frame From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a confirmed response of PR or CR.
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m² All Participants
Hide Arm/Group Description:
Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Overall Number of Participants Analyzed 3 3 2 5 2 15
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(2.8 to 5.4)
5.0
(4.7 to 5.6)
NA [1] 
(2.8 to NA)
4.3 [1] 
(1.6 to NA)
4.5
(4.2 to 4.8)
4.8
(2.8 to 5.4)
[1]
Could not be estimated due to the low number of events
Time Frame From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide), and within 30 days of the last day of study treatment. The median overall duration of treatment was 16 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Hide Arm/Group Description Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
All-Cause Mortality
Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/5 (20.00%)   1/3 (33.33%)   1/3 (33.33%)   7/15 (46.67%)   2/6 (33.33%) 
Blood and lymphatic system disorders           
Anaemia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Febrile neutropenia  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/15 (13.33%)  0/6 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Infections and infestations           
Clostridium difficile colitis  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Injection site abscess  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pneumonia  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/15 (6.67%)  1/6 (16.67%) 
Metabolism and nutrition disorders           
Fluid overload  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Hypoalbuminaemia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Nervous system disorders           
Cerebrovascular accident  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Nervous system disorder  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pulmonary embolism  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pulmonary haemorrhage  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Pulmonary oedema  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Vascular disorders           
Peripheral artery thrombosis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carfilzomib 20/20 mg/m² Carfilzomib 20/27 mg/m² Carfilzomib 20/36 mg/m² Carfilzomib 20/45 mg/m² Carfilzomib 20/56 mg/m²
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   15/15 (100.00%)   5/6 (83.33%) 
Blood and lymphatic system disorders           
Anaemia  1  2/5 (40.00%)  3/3 (100.00%)  2/3 (66.67%)  8/15 (53.33%)  3/6 (50.00%) 
Leukocytosis  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Leukopenia  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  3/15 (20.00%)  1/6 (16.67%) 
Neutropenia  1  1/5 (20.00%)  2/3 (66.67%)  0/3 (0.00%)  10/15 (66.67%)  3/6 (50.00%) 
Thrombocytopenia  1  0/5 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  7/15 (46.67%)  4/6 (66.67%) 
Ear and labyrinth disorders           
Ear congestion  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Ear discomfort  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Ear pain  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Hypoacusis  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Vertigo  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Abdominal distension  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Abdominal pain  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Constipation  1  3/5 (60.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Diarrhoea  1  1/5 (20.00%)  2/3 (66.67%)  1/3 (33.33%)  5/15 (33.33%)  0/6 (0.00%) 
Flatulence  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Haematochezia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Nausea  1  3/5 (60.00%)  3/3 (100.00%)  3/3 (100.00%)  5/15 (33.33%)  1/6 (16.67%) 
Oesophagitis  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Stomatitis  1  0/5 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  2/15 (13.33%)  0/6 (0.00%) 
Toothache  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Vomiting  1  0/5 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  3/15 (20.00%)  0/6 (0.00%) 
General disorders           
Asthenia  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/15 (13.33%)  1/6 (16.67%) 
Catheter site pain  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Chills  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Fatigue  1  1/5 (20.00%)  1/3 (33.33%)  1/3 (33.33%)  4/15 (26.67%)  2/6 (33.33%) 
Mucosal inflammation  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Non-cardiac chest pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Oedema peripheral  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  1/6 (16.67%) 
Pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pyrexia  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  1/6 (16.67%) 
Immune system disorders           
Hypersensitivity  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Infections and infestations           
Cellulitis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Clostridium difficile colitis  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Influenza  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Injection site infection  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Lower respiratory tract infection  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Lung infection  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Mucosal infection  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Oral candidiasis  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Oral herpes  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Pneumonia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Respiratory tract infection  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Sinusitis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Skin infection  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Upper respiratory tract infection  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Vulvovaginal candidiasis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Vulvovaginal mycotic infection  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Head injury  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Incision site erythema  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Incision site swelling  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Infusion related reaction  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Laceration  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Wound  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Aspartate aminotransferase increased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Blood alkaline phosphatase increased  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Blood creatinine increased  1  0/5 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/15 (6.67%)  2/6 (33.33%) 
Blood glucose increased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Blood phosphorus increased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Blood potassium decreased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Blood urea increased  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Blood uric acid increased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Creatinine renal clearance decreased  1  2/5 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  2/6 (33.33%) 
Ejection fraction decreased  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Haemoglobin decreased  1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Neutrophil count decreased  1  1/5 (20.00%)  2/3 (66.67%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Platelet count decreased  1  0/5 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  2/15 (13.33%)  2/6 (33.33%) 
Weight decreased  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/15 (13.33%)  0/6 (0.00%) 
Weight increased  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
White blood cell count decreased  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/15 (6.67%)  1/6 (16.67%) 
Metabolism and nutrition disorders           
Decreased appetite  1  2/5 (40.00%)  0/3 (0.00%)  2/3 (66.67%)  2/15 (13.33%)  1/6 (16.67%) 
Dehydration  1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Diabetes mellitus  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Gout  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Hyperglycaemia  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Hyperkalaemia  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Hypoalbuminaemia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypocalcaemia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypoglycaemia  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypokalaemia  1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Hypomagnesaemia  1  0/5 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Hyponatraemia  1  0/5 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Metabolic acidosis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  3/15 (20.00%)  0/6 (0.00%) 
Bone pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  1/6 (16.67%) 
Costochondritis  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Groin pain  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Muscular weakness  1  0/5 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  3/15 (20.00%)  0/6 (0.00%) 
Musculoskeletal chest pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Musculoskeletal pain  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Neck pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pain in extremity  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cancer pain  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Nervous system disorders           
Ageusia  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Cerebrovascular accident  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Decreased vibratory sense  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Dizziness  1  0/5 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  3/15 (20.00%)  1/6 (16.67%) 
Dysgeusia  1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Headache  1  0/5 (0.00%)  2/3 (66.67%)  2/3 (66.67%)  3/15 (20.00%)  0/6 (0.00%) 
Hypoaesthesia  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Hyporeflexia  1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Neuropathy peripheral  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Paraesthesia  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Peripheral sensory neuropathy  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Tremor  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Vocal cord paralysis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Psychiatric disorders           
Anxiety  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Confusional state  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Depression  1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Insomnia  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Renal and urinary disorders           
Dysuria  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Micturition disorder  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Reproductive system and breast disorders           
Breast pain  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Aspiration  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Cough  1  1/5 (20.00%)  1/3 (33.33%)  1/3 (33.33%)  1/15 (6.67%)  1/6 (16.67%) 
Dry throat  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Dyspnoea  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  2/15 (13.33%)  1/6 (16.67%) 
Haemoptysis  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Hypoxia  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Nasal congestion  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Oropharyngeal pain  1  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pleural effusion  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Pulmonary embolism  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/15 (6.67%)  0/6 (0.00%) 
Pulmonary oedema  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Rhinorrhoea  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Wheezing  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  1/5 (20.00%)  0/3 (0.00%)  2/3 (66.67%)  5/15 (33.33%)  1/6 (16.67%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Pruritus  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Rash  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Rash macular  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Skin discolouration  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Skin irritation  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Swelling face  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Vascular disorders           
Deep vein thrombosis  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Flushing  1  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypertension  1  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypotension  1  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  1/6 (16.67%) 
Jugular vein thrombosis  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Orthostatic hypotension  1  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/15 (0.00%)  0/6 (0.00%) 
Phlebitis  1  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01987232    
Other Study ID Numbers: CFZ004
2013-002597-44 ( EudraCT Number )
20130399 ( Other Identifier: Amgen Inc. )
First Submitted: November 6, 2013
First Posted: November 19, 2013
Results First Submitted: July 26, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017