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A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)

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: NCT02451943
Recruitment Status : Active, not recruiting
First Posted : May 22, 2015
Results First Posted : December 17, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Soft Tissue Sarcoma
Interventions Drug: Olaratumab
Drug: Doxorubicin
Drug: Placebo
Enrollment 509
Recruitment Details  
Pre-assignment Details Completers include participants who died or alive and on study at conclusion, but off treatment.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle up to 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle thereafter until documented progressive disease (PD) or discontinuation for any other reason. 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle up to 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle thereafter until PD or discontinuation for any other reason.
Period Title: Overall Study
Started 258 251
Received at Least One Dose of Study Drug 257 249
Leiomyosarcoma (LMS) Population 119 115
Completed 238 227
Not Completed 20 24
Reason Not Completed
On Treatment             4             4
Withdrawal by Subject             13             16
Lost to Follow-up             3             4
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo Total
Hide Arm/Group Description 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason. 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. Total of all reporting groups
Overall Number of Baseline Participants 258 251 509
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 251 participants 509 participants
56.7  (12.4) 57.1  (11.6) 56.9  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 251 participants 509 participants
Female 144 152 296
Male 114 99 213
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 251 participants 509 participants
Hispanic or Latino 26 29 55
Not Hispanic or Latino 209 199 408
Unknown or Not Reported 23 23 46
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 251 participants 509 participants
American Indian or Alaska Native 3 3 6
Asian 50 48 98
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 12 2 14
White 186 193 379
More than one race 5 4 9
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 251 participants 509 participants
United States 69 73 142
Russia 7 8 15
Austria 3 0 3
South Korea 15 13 28
Netherlands 8 6 14
Sweden 4 3 7
Brazil 2 0 2
Poland 3 2 5
France 17 18 35
Argentina 3 4 7
Hungary 9 11 20
Japan 23 22 45
United Kingdom 10 16 26
Switzerland 4 2 6
Spain 13 21 34
Canada 12 6 18
Belgium 11 10 21
Finland 4 2 6
Taiwan 6 7 13
Denmark 10 2 12
Italy 5 4 9
Mexico 7 6 13
Israel 6 5 11
Australia 0 1 1
Germany 7 9 16
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Time Frame Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants in Doxorubicin + Olaratumab arm = 87 and Doxorubicin + Placebo arm = 91
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 258 251
Median (95% Confidence Interval)
Unit of Measure: Months
20.37
(17.84 to 22.90)
19.75
(16.49 to 23.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxorubicin + Olaratumab, Doxorubicin + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6945
Comments [Not Specified]
Method Log Rank
Comments Stratified
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.047
Confidence Interval (2-Sided) 95%
0.841 to 1.303
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS) Leiomyosarcoma (LMS)
Hide Description Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Time Frame Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 119 115
Median (95% Confidence Interval)
Unit of Measure: Months
21.55
(18.63 to 27.63)
21.88
(17.54 to 25.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxorubicin + Olaratumab, Doxorubicin + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7618
Comments [Not Specified]
Method Log Rank
Comments Stratified
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.951
Confidence Interval (2-Sided) 95%
0.690 to 1.312
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
Time Frame Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 258 251
Median (95% Confidence Interval)
Unit of Measure: Months
5.42
(4.11 to 6.70)
6.77
(5.49 to 8.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxorubicin + Olaratumab, Doxorubicin + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments [Not Specified]
Method Log Rank
Comments Stratified
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.231
Confidence Interval (2-Sided) 95%
1.009 to 1.502
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
Time Frame Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 258 251
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.0
(9.7 to 18.2)
18.3
(13.5 to 23.1)
5.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 45 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 258 251
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.4
(61.7 to 73.2)
75.7
(70.4 to 81.0)
6.Secondary Outcome
Title Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
Hide Description Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales [physical, role, cognitive, emotional, and social]), and 9 symptom subscales [fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
Time Frame Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 258 251
Median (95% Confidence Interval)
Unit of Measure: Months
Global Health Status/QoL Number Analyzed 201 participants 197 participants
1.45
(1.41 to 2.10)
1.84
(1.45 to 2.79)
Role Functional Scale Number Analyzed 202 participants 190 participants
1.41
(0.99 to 1.48)
1.41
(0.95 to 2.00)
Physical Functional Scale Number Analyzed 205 participants 209 participants
1.81
(1.45 to 2.14)
2.79
(2.07 to 3.48)
Emotional Functional Scale Number Analyzed 168 participants 171 participants
3.48
(2.50 to 4.37)
2.83
(2.14 to 4.34)
Cognitive Functional Scale Number Analyzed 170 participants 167 participants
1.64
(1.41 to 2.14)
1.45
(1.41 to 2.07)
Social Functional Scale Number Analyzed 189 participants 171 participants
1.45
(1.38 to 1.64)
1.41
(1.35 to 1.45)
Fatigue Symptom Scale Number Analyzed 210 participants 204 participants
0.92
(0.76 to 1.25)
0.89
(0.76 to 1.38)
Nausea and Vomiting Symptom Scale Number Analyzed 182 participants 173 participants
1.45
(1.41 to 1.64)
1.41
(0.95 to 1.45)
Pain Symptom Scale Number Analyzed 185 participants 183 participants
1.64
(1.41 to 2.10)
2.10
(1.45 to 2.76)
Dyspnea Symptom Scale Number Analyzed 158 participants 160 participants
2.10
(1.45 to 2.76)
2.07
(1.45 to 2.79)
Insomnia Symptom Scale Number Analyzed 151 participants 160 participants
2.10
(1.45 to 2.79)
1.58
(1.41 to 2.33)
Appetite Loss Symptom Scale Number Analyzed 182 participants 170 participants
1.48
(1.45 to 2.04)
1.64
(1.41 to 2.14)
Financial Difficulties Scale Number Analyzed 132 participants 105 participants
1.48
(1.41 to 2.14)
1.45
(1.41 to 2.10)
Constipation Symptom Scale Number Analyzed 169 participants 157 participants
1.64
(1.41 to 2.10)
1.41
(1.41 to 2.10)
Diarrhea Symptom Scale Number Analyzed 157 participants 148 participants
2.07
(1.45 to 2.79)
2.79
(2.10 to 3.52)
7.Secondary Outcome
Title Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Hide Description The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores.
Time Frame Randomization through Follow-up (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a baseline and a post-baseline measurement.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 221 219
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.163  (0.236) -0.171  (0.235)
8.Secondary Outcome
Title Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Hide Description Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes).
Time Frame Randomization through Follow-up (Up to 34.5 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 211 206
Median (95% Confidence Interval)
Unit of Measure: Months
7.66
(6.01 to 9.63)
8.08
(6.18 to 11.07)
9.Secondary Outcome
Title Duration of Overall Response (DoR)
Hide Description The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study).
Time Frame Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have evaluable DoR data.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 36 46
Median (95% Confidence Interval)
Unit of Measure: Months
8.31
(6.87 to 12.35)
4.80
(3.65 to 6.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxorubicin + Olaratumab, Doxorubicin + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0934
Comments [Not Specified]
Method Log Rank
Comments Stratified
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.616
Confidence Interval (2-Sided) 95%
0.347 to 1.093
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Duration of Disease Control (DDC)
Hide Description Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause.
Time Frame Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had evaluable DDC data.
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Overall Number of Participants Analyzed 174 190
Median (95% Confidence Interval)
Unit of Measure: Months
8.28
(6.93 to 9.72)
8.34
(8.08 to 9.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxorubicin + Olaratumab, Doxorubicin + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3347
Comments [Not Specified]
Method Log Rank
Comments Stratified
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.123
Confidence Interval (2-Sided) 95%
0.892 to 1.413
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate
Hide Description The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.
Time Frame Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title Doxorubicin + Olaratumab
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
Overall Number of Participants Analyzed 258
Mean (95% Confidence Interval)
Unit of Measure: Liter/hour (L/h)
0.0195
(0.0189 to 0.0203)
12.Secondary Outcome
Title PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate
Hide Description The PK parameter estimates from the current analysis are listed together with the population PK model estimates. The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).
Time Frame Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had received at least one dose of study drug and had evaluable PK data.
Arm/Group Title Doxorubicin + Olaratumab
Hide Arm/Group Description:
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
Overall Number of Participants Analyzed 258
Mean (95% Confidence Interval)
Unit of Measure: Liter (L)
5.72
(5.28 to 6.17)
Time Frame From Baseline to Study Completion (Up to 3 Years and 1 Month)
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Doxorubicin + Olaratumab Doxorubicin + Placebo
Hide Arm/Group Description 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason. 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
All-Cause Mortality
Doxorubicin + Olaratumab Doxorubicin + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   170/257 (66.15%)      158/249 (63.45%)    
Hide Serious Adverse Events
Doxorubicin + Olaratumab Doxorubicin + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/257 (40.08%)      89/249 (35.74%)    
Blood and lymphatic system disorders     
Anemia  1  4/257 (1.56%)  6 2/249 (0.80%)  2
Febrile bone marrow aplasia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Febrile neutropenia  1  33/257 (12.84%)  36 33/249 (13.25%)  38
Leukopenia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Neutropenia  1  8/257 (3.11%)  10 8/249 (3.21%)  8
Pancytopenia  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Thrombocytopenia  1  1/257 (0.39%)  2 2/249 (0.80%)  5
Cardiac disorders     
Arrhythmia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Atrial fibrillation  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Cardiac failure  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Cardiac failure acute  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Cardiac failure congestive  1  0/257 (0.00%)  0 2/249 (0.80%)  2
Left ventricular dysfunction  1  2/257 (0.78%)  2 1/249 (0.40%)  1
Mitral valve disease  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Myocarditis  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Pericarditis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Supraventricular tachycardia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/257 (0.39%)  1 2/249 (0.80%)  2
Acute abdomen  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Colitis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Constipation  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Diarrhea  1  3/257 (1.17%)  3 0/249 (0.00%)  0
Duodenal ulcer  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Dyspepsia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Food poisoning  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Gastric hemorrhage  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Ileus  1  0/257 (0.00%)  0 2/249 (0.80%)  2
Intestinal obstruction  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Intussusception  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Nausea  1  4/257 (1.56%)  5 0/249 (0.00%)  0
Small intestinal obstruction  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Stomatitis  1  1/257 (0.39%)  1 2/249 (0.80%)  3
Subileus  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Vomiting  1  4/257 (1.56%)  5 1/249 (0.40%)  1
General disorders     
Asthenia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Extravasation  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Fatigue  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Malaise  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Mucosal inflammation  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Non-cardiac chest pain  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Pyrexia  1  2/257 (0.78%)  2 7/249 (2.81%)  7
Hepatobiliary disorders     
Hepatic pain  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Immune system disorders     
Anaphylactic reaction  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Anaphylactic shock  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Hypersensitivity  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Infections and infestations     
Abdominal infection  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Abscess  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Bacteraemia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Cellulitis  1  0/257 (0.00%)  0 2/249 (0.80%)  2
Clostridium difficile colitis  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Cystitis  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Device related infection  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Gastroenteritis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Gingivitis  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Herpes zoster  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Infection  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Neutropenic infection  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Neutropenic sepsis  1  1/257 (0.39%)  2 1/249 (0.40%)  1
Pneumonia  1  4/257 (1.56%)  4 2/249 (0.80%)  2
Pseudomonal bacteraemia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Rectal abscess  1  1/257 (0.39%)  2 0/249 (0.00%)  0
Respiratory tract infection  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Sepsis  1  4/257 (1.56%)  4 2/249 (0.80%)  2
Septic shock  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Skin infection  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Tonsillitis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Upper respiratory tract infection  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Urinary tract infection  1  3/257 (1.17%)  3 1/249 (0.40%)  1
Wound infection  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Femur fracture  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Rib fracture  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Spinal fracture  1  0/257 (0.00%)  0 2/249 (0.80%)  2
Tibia fracture  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Investigations     
Ejection fraction decreased  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Electrocardiogram abnormal  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Neutrophil count decreased  1  5/257 (1.95%)  6 4/249 (1.61%)  7
Platelet count decreased  1  2/257 (0.78%)  4 2/249 (0.80%)  5
Troponin increased  1  1/257 (0.39%)  1 0/249 (0.00%)  0
White blood cell count decreased  1  2/257 (0.78%)  7 3/249 (1.20%)  6
Metabolism and nutrition disorders     
Decreased appetite  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Dehydration  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Hyperglycemia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Hypoglycemia  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Hypokalemia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Back pain  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Intervertebral disc protrusion  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Musculoskeletal pain  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Pathological fracture  1  2/257 (0.78%)  2 0/249 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Dysarthria  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Headache  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Ischaemic stroke  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Migraine  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Nervous system disorder  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Paraparesis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Sciatic nerve neuropathy  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Somnolence  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Syncope  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Vertebral artery dissection  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/257 (0.00%)  0 1/249 (0.40%)  2
Nephrolithiasis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Renal failure  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Reproductive system and breast disorders     
Vaginal hemorrhage  1  0/144 (0.00%)  0 1/151 (0.66%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Aspiration  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Dyspnea  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Hypoxia  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Pleural effusion  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Pneumonia aspiration  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Pneumonitis  1  1/257 (0.39%)  1 1/249 (0.40%)  1
Pneumothorax  1  1/257 (0.39%)  1 3/249 (1.20%)  5
Pulmonary embolism  1  7/257 (2.72%)  7 3/249 (1.20%)  3
Respiratory failure  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  5/257 (1.95%)  5 1/249 (0.40%)  1
Embolism  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Hypotension  1  2/257 (0.78%)  3 1/249 (0.40%)  1
Peripheral arterial occlusive disease  1  0/257 (0.00%)  0 1/249 (0.40%)  1
Thrombophlebitis superficial  1  1/257 (0.39%)  1 0/249 (0.00%)  0
Venous thrombosis  1  0/257 (0.00%)  0 1/249 (0.40%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxorubicin + Olaratumab Doxorubicin + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   249/257 (96.89%)      246/249 (98.80%)    
Blood and lymphatic system disorders     
Anemia  1  109/257 (42.41%)  294 113/249 (45.38%)  389
Febrile neutropenia  1  13/257 (5.06%)  13 9/249 (3.61%)  12
Leukopenia  1  14/257 (5.45%)  48 11/249 (4.42%)  26
Neutropenia  1  59/257 (22.96%)  165 59/249 (23.69%)  140
Thrombocytopenia  1  14/257 (5.45%)  33 19/249 (7.63%)  45
Gastrointestinal disorders     
Abdominal pain  1  30/257 (11.67%)  42 37/249 (14.86%)  47
Abdominal pain upper  1  15/257 (5.84%)  21 20/249 (8.03%)  24
Constipation  1  79/257 (30.74%)  121 86/249 (34.54%)  141
Diarrhea  1  74/257 (28.79%)  123 75/249 (30.12%)  116
Dry mouth  1  22/257 (8.56%)  23 19/249 (7.63%)  21
Dyspepsia  1  27/257 (10.51%)  32 29/249 (11.65%)  35
Gastrooesophageal reflux disease  1  16/257 (6.23%)  17 18/249 (7.23%)  21
Nausea  1  151/257 (58.75%)  303 166/249 (66.67%)  377
Stomatitis  1  79/257 (30.74%)  148 93/249 (37.35%)  189
Vomiting  1  62/257 (24.12%)  78 69/249 (27.71%)  125
General disorders     
Asthenia  1  24/257 (9.34%)  60 28/249 (11.24%)  77
Fatigue  1  125/257 (48.64%)  230 125/249 (50.20%)  291
Malaise  1  11/257 (4.28%)  13 15/249 (6.02%)  21
Edema peripheral  1  34/257 (13.23%)  43 23/249 (9.24%)  42
Pyrexia  1  48/257 (18.68%)  63 40/249 (16.06%)  61
Infections and infestations     
Nasopharyngitis  1  10/257 (3.89%)  13 16/249 (6.43%)  17
Rhinitis  1  6/257 (2.33%)  6 13/249 (5.22%)  16
Upper respiratory tract infection  1  25/257 (9.73%)  31 24/249 (9.64%)  28
Urinary tract infection  1  18/257 (7.00%)  24 21/249 (8.43%)  24
Investigations     
Alanine aminotransferase increased  1  19/257 (7.39%)  37 19/249 (7.63%)  37
Aspartate aminotransferase increased  1  10/257 (3.89%)  12 19/249 (7.63%)  29
Gamma-glutamyltransferase increased  1  18/257 (7.00%)  33 17/249 (6.83%)  28
Lymphocyte count decreased  1  17/257 (6.61%)  86 17/249 (6.83%)  51
Neutrophil count decreased  1  92/257 (35.80%)  254 89/249 (35.74%)  317
Platelet count decreased  1  46/257 (17.90%)  142 45/249 (18.07%)  200
Weight decreased  1  24/257 (9.34%)  29 22/249 (8.84%)  32
White blood cell count decreased  1  68/257 (26.46%)  245 69/249 (27.71%)  300
Metabolism and nutrition disorders     
Decreased appetite  1  71/257 (27.63%)  116 92/249 (36.95%)  144
Dehydration  1  18/257 (7.00%)  24 9/249 (3.61%)  13
Hypokalemia  1  13/257 (5.06%)  16 11/249 (4.42%)  15
Musculoskeletal and connective tissue disorders     
Arthralgia  1  29/257 (11.28%)  32 19/249 (7.63%)  25
Back pain  1  29/257 (11.28%)  45 28/249 (11.24%)  37
Muscle spasms  1  18/257 (7.00%)  25 8/249 (3.21%)  9
Pain in extremity  1  24/257 (9.34%)  32 25/249 (10.04%)  40
Nervous system disorders     
Dizziness  1  27/257 (10.51%)  45 34/249 (13.65%)  49
Dysgeusia  1  45/257 (17.51%)  55 51/249 (20.48%)  64
Headache  1  42/257 (16.34%)  59 42/249 (16.87%)  57
Paraesthesia  1  12/257 (4.67%)  16 16/249 (6.43%)  17
Psychiatric disorders     
Anxiety  1  11/257 (4.28%)  18 13/249 (5.22%)  14
Insomnia  1  23/257 (8.95%)  28 30/249 (12.05%)  36
Respiratory, thoracic and mediastinal disorders     
Cough  1  43/257 (16.73%)  52 61/249 (24.50%)  78
Dyspnea  1  45/257 (17.51%)  54 36/249 (14.46%)  49
Epistaxis  1  7/257 (2.72%)  7 13/249 (5.22%)  19
Oropharyngeal pain  1  15/257 (5.84%)  19 18/249 (7.23%)  23
Skin and subcutaneous tissue disorders     
Alopecia  1  112/257 (43.58%)  133 124/249 (49.80%)  163
Pruritus  1  14/257 (5.45%)  15 23/249 (9.24%)  26
Rash  1  12/257 (4.67%)  14 17/249 (6.83%)  19
Vascular disorders     
Hypertension  1  16/257 (6.23%)  21 20/249 (8.03%)  30
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02451943    
Other Study ID Numbers: 15677
I5B-MC-JGDJ ( Other Identifier: Eli Lilly and Company )
2015-000134-30 ( EudraCT Number )
First Submitted: May 20, 2015
First Posted: May 22, 2015
Results First Submitted: November 27, 2019
Results First Posted: December 17, 2019
Last Update Posted: September 25, 2020