Trial Outcomes & Findings for A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer (NCT NCT00642018)
NCT ID: NCT00642018
Last Updated: 2019-04-03
Results Overview
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Baseline to measured progressive disease or death due to any cause up to 44.68 months
Results posted on
2019-04-03
Participant Flow
Participant milestones
| Measure |
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
102
|
|
Overall Study
Received at Least One Dose of Study Drug
|
51
|
98
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
28
|
79
|
Reasons for withdrawal
| Measure |
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
36
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Progressive Disease
|
13
|
18
|
|
Overall Study
Physician Decision
|
0
|
10
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Entry Criteria Not Met
|
0
|
1
|
Baseline Characteristics
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.09 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
68.25 years
STANDARD_DEVIATION 8.70 • n=7 Participants
|
68.20 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
49 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured progressive disease or death due to any cause up to 44.68 monthsPopulation: All randomized participants who received at least one dose of the study drug. The numbers of participants censored were 10 (Docetaxel group) and 22 (LY2181308 + Docetaxel group).
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
|
9.00 months
Interval 7.0 to 10.09
|
8.64 months
Interval 7.39 to 10.45
|
PRIMARY outcome
Timeframe: First treatment dose up to 19 monthsPopulation: All randomized participants who received at least one dose of study drug.
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety)
Serious Adverse Events
|
11 Participants
|
47 Participants
|
|
Number of Participants With Adverse Events (Safety)
Other Nonserious Adverse Events
|
50 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: First treatment dose up to 19 monthsPopulation: All randomized participants who received at least one dose of study drug.
Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Adverse Event Profile
TEAEs
|
45 Participants
|
91 Participants
|
|
Adverse Event Profile
SAEs
|
5 Participants
|
27 Participants
|
|
Adverse Event Profile
Discontinuations due to AEs
|
6 Participants
|
22 Participants
|
|
Adverse Event Profile
Discontinuations due to SAEs
|
1 Participants
|
3 Participants
|
|
Adverse Event Profile
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose up to 8 hours postdose in Cycle 1Population: All randomized participants who received at least one dose of the study drug and had pharmacokinetics data.
Outcome measures
| Measure |
Docetaxel
n=24 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=48 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
|
825 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 56.6
|
799 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 59.7
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: All randomized participants who received at least one dose of study drug.
PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100\*n/N where n=the number of participants with responses and N=the total number of participants treated.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
|
56.9 percentage of participants
|
56.1 percentage of participants
|
SECONDARY outcome
Timeframe: First treatment to death due to any cause up to 45.54 monthsPopulation: All randomized participants who received at least one dose of study drug. The numbers of participants censored were 25 (Docetaxel group) and 49 (LY2181308 + Docetaxel group).
Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Estimate Overall Survival
|
29.04 months
Interval 20.11 to 39.26
|
27.04 months
Interval 19.94 to 33.41
|
SECONDARY outcome
Timeframe: Time of response to time of measured progressive disease up to 41.00 monthsPopulation: All randomized participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR). The numbers of participants censored were 3 (Docetaxel group) and 1 (LY2181308 + Docetaxel group).
The duration of response \[complete response (CR) or partial response (PR)\] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact.
Outcome measures
| Measure |
Docetaxel
n=11 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=10 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Estimate Duration of Overall Response
|
10.81 months
Interval 7.49 to 14.29
|
9.66 months
Interval 6.93 to 11.07
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease up to 41.00 monthsPopulation: All randomized participants who received at least one dose of study drug.
Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)
|
21.6 percentage of participants
Interval 13.0 to 33.0
|
10.2 percentage of participants
Interval 6.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: All randomized participants who received at least one dose of study drug and had G-CSF measurement at baseline and 21 days.
G-CSF \[international units per milliliter (IU/mL)\] was used to estimate biomarker responses and is presented as the percentage change from baseline.
Outcome measures
| Measure |
Docetaxel
n=49 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)
|
-32.5 percentage change
|
233.3 percentage change
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized participants who received at least one dose of study drug and had FACT-P assessment at 3 months.
The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms.
Outcome measures
| Measure |
Docetaxel
n=42 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=74 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)
|
117 units on a scale
Interval 108.0 to 128.0
|
115 units on a scale
Interval 93.0 to 129.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized participants who received at least one dose of study drug and had FACT-G assessment at 3 months.
The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms.
Outcome measures
| Measure |
Docetaxel
n=42 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=75 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)
|
84 units on a scale
Interval 75.0 to 92.0
|
80 units on a scale
Interval 66.0 to 94.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study treatment discontinuation up to 30 days post study treatment discontinuationPopulation: All randomized participants who received at least one dose of the study drug.
Outcome measures
| Measure |
Docetaxel
n=51 Participants
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 Participants
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
|
1 Participants
|
0 Participants
|
Adverse Events
Docetaxel
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
LY2181308 + Docetaxel
Serious events: 47 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=51 participants at risk
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 participants at risk
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
4.1%
4/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Intussusception
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Asthenia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Fatigue
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
General physical health deterioration
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Multi-organ failure
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Abscess limb
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Soft tissue infection
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Cranial nerve disorder
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Renal and urinary disorders
Urethral obstruction
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
4.1%
4/98 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
4.1%
4/98 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
Other adverse events
| Measure |
Docetaxel
n=51 participants at risk
Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
LY2181308 + Docetaxel
n=98 participants at risk
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.6%
10/51 • Number of events 21
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
39.8%
39/98 • Number of events 59
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
29.4%
15/51 • Number of events 51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
34.7%
34/98 • Number of events 87
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.8%
30/51 • Number of events 106
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
59.2%
58/98 • Number of events 172
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
48.0%
47/98 • Number of events 87
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Endocrine disorders
Cushingoid
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
0.00%
0/98
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Eye disorders
Lacrimation increased
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
13.3%
13/98 • Number of events 17
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
5/51 • Number of events 8
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
6/51 • Number of events 9
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
23.5%
23/98 • Number of events 30
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
39.2%
20/51 • Number of events 36
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
42.9%
42/98 • Number of events 84
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
14.3%
14/98 • Number of events 16
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
5/51 • Number of events 8
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
7.1%
7/98 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
13/51 • Number of events 20
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
41.8%
41/98 • Number of events 87
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
4/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
8.2%
8/98 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
24.5%
24/98 • Number of events 38
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Asthenia
|
25.5%
13/51 • Number of events 26
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
21.4%
21/98 • Number of events 35
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Chest pain
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Chills
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
12.2%
12/98 • Number of events 13
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Fatigue
|
43.1%
22/51 • Number of events 44
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
38.8%
38/98 • Number of events 72
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Influenza like illness
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
9.2%
9/98 • Number of events 13
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Mucosal inflammation
|
15.7%
8/51 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
9.2%
9/98 • Number of events 15
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Oedema peripheral
|
21.6%
11/51 • Number of events 15
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
34.7%
34/98 • Number of events 41
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
General disorders
Pyrexia
|
9.8%
5/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
35.7%
35/98 • Number of events 43
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
4/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
4.1%
4/98 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 11
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
9.2%
9/98 • Number of events 17
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
8.2%
8/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Investigations
Weight decreased
|
9.8%
5/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
15.3%
15/98 • Number of events 16
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.6%
11/51 • Number of events 14
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
26.5%
26/98 • Number of events 31
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.8%
4/51 • Number of events 13
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
11.2%
11/98 • Number of events 23
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
9.2%
9/98 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
1.0%
1/98 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
5/51 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
15.3%
15/98 • Number of events 18
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
8.2%
8/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
3/51 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
2.0%
2/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
8.2%
8/98 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
4/51 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
10.2%
10/98 • Number of events 13
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Dizziness
|
13.7%
7/51 • Number of events 8
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
10.2%
10/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
23.5%
12/51 • Number of events 20
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
26.5%
26/98 • Number of events 38
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Headache
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
13.3%
13/98 • Number of events 24
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.8%
4/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
7.1%
7/98 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
13.7%
7/51 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
12.2%
12/98 • Number of events 15
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.8%
5/51 • Number of events 8
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Nervous system disorders
Syncope
|
3.9%
2/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Psychiatric disorders
Insomnia
|
9.8%
5/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
4.1%
4/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
5.1%
5/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
2/51 • Number of events 2
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
13.3%
13/98 • Number of events 14
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.8%
5/51 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
21.4%
21/98 • Number of events 26
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.8%
5/51 • Number of events 6
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
10.2%
10/98 • Number of events 15
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
12.2%
12/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.1%
22/51 • Number of events 23
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
40.8%
40/98 • Number of events 41
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/51 • Number of events 1
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
10.2%
10/98 • Number of events 10
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
13.7%
7/51 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
14.3%
14/98 • Number of events 14
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
5.9%
3/51 • Number of events 4
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/51
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
9.2%
9/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Vascular disorders
Flushing
|
11.8%
6/51 • Number of events 18
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 5
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Vascular disorders
Hot flush
|
5.9%
3/51 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
3.1%
3/98 • Number of events 3
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
|
Vascular disorders
Hypotension
|
7.8%
4/51 • Number of events 7
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
6.1%
6/98 • Number of events 12
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60