Trial Outcomes & Findings for A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer (NCT NCT00683475)
NCT ID: NCT00683475
Last Updated: 2014-10-16
Results Overview
Defined as the median time from randomization to the earliest of: 1. Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST); 2. Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of \>=2 new lesions; 3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression) 4. Symptomatic progression (for participants without measurable disease); 5. Other clinical events attributable to prostate cancer that require major interventions; or 6. Death from any cause Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.
COMPLETED
PHASE2
138 participants
Randomization to composite progressive disease, up to 23.4 months
2014-10-16
Participant Flow
Participant milestones
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
|
Overall Study
Received Any Quantity of Study Drug
|
66
|
66
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Never Treated: Adverse Event
|
2
|
3
|
|
Overall Study
Never Treated: Progressive Disease
|
1
|
0
|
Baseline Characteristics
A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer
Baseline characteristics by cohort
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
81 Participants
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
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
66 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to composite progressive disease, up to 23.4 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. 11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm.
Defined as the median time from randomization to the earliest of: 1. Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST); 2. Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of \>=2 new lesions; 3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression) 4. Symptomatic progression (for participants without measurable disease); 5. Other clinical events attributable to prostate cancer that require major interventions; or 6. Death from any cause Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Composite Progression-free Survival (cPFS)
|
4.1 months
Interval 2.2 to 5.6
|
6.7 months
Interval 4.5 to 8.3
|
SECONDARY outcome
Timeframe: Randomization to 36.3 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
A12/1121B Related TEAE
|
64 participants
|
63 participants
|
|
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
TEAE Leading to Dose Modification of A12/1121B
|
35 participants
|
35 participants
|
|
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
TEAE Leading to Discontinuation of A12/1121B
|
18 participants
|
25 participants
|
|
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
A12/1121B Related Serious TEAE
|
22 participants
|
16 participants
|
|
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
A12/1121B Related Grade >= 3 TEAE
|
35 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Randomization to date of radiographic progression, up to 36.3 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. 34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm.
Time between date of randomization and earliest date of radiographic progression defined as either: 1. Tumor progression by RECIST; 2. Evidence of progression by bone scan; 3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression). Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Time to Radiographic Evidence of Disease Progression
|
7.5 months
Interval 4.8 to 10.1
|
10.2 months
Interval 7.5 to 12.6
|
SECONDARY outcome
Timeframe: Baseline up to data cut-off date (up to 36.3 months)Population: Participants who received any quantity of study drug, had baseline PSA value \>= 2 ng/ml and at least one non-missing post-baseline PSA.
PSA response rate is defined as the percentage of participants with a decrease in PSA \>= 50 percent from baseline.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=54 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=56 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Response Rate
|
18.5 percentage of participants
Interval 9.3 to 31.4
|
21.4 percentage of participants
Interval 11.6 to 34.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Data presented are the percentage of participants without disease progression at 6 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Composite Progression-free Survival (cPFS) at 6-months
|
37.2 percentage of participants
Interval 25.0 to 49.4
|
59.2 percentage of participants
Interval 45.8 to 70.4
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Data presented are the percentage of participants without disease progression at 9 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Composite Progression-free Survival (cPFS) at 9-months
|
20.7 percentage of participants
Interval 11.2 to 32.1
|
35.9 percentage of participants
Interval 23.4 to 48.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug.
Data presented are the percentage of participants without disease progression at 12 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Composite Progression-free Survival (cPFS) at 12-months
|
12.4 percentage of participants
Interval 5.2 to 22.9
|
20.0 percentage of participants
Interval 10.1 to 32.3
|
SECONDARY outcome
Timeframe: First dose to death due to any cause up to 36.3 monthsPopulation: Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm
Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
10.8 months
Interval 6.5 to 13.0
|
13.0 months
Interval 9.5 to 16.0
|
SECONDARY outcome
Timeframe: Baseline to date of progressive disease or death up to 36.3 monthsPopulation: Participants with measurable disease at baseline, who received any quantity of study drug.
Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
Outcome measures
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=46 Participants
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=38 Participants
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
15.2 percentage of participants
Interval 6.3 to 28.9
|
31.6 percentage of participants
Interval 17.5 to 48.7
|
SECONDARY outcome
Timeframe: Day 1Population: Zero participants were analyzed.
Maximum Concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: Zero participants were analyzed.
Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 16Population: Zero participants were analyzed.
Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30Population: Zero participants were analyzed.
Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: Zero participants were analyzed.
Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: Zero participants were analyzed.
Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 16Population: Zero participants were analyzed.
Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30Population: Zero participants were analyzed.
Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.
Outcome measures
Outcome data not reported
Adverse Events
IMC-A12 + Mitoxantrone + Prednisone
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
Serious adverse events
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 participants at risk
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 participants at risk
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.0%
2/66 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.5%
1/66 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.0%
2/66 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.5%
1/66 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Cardiac disorders
CARDIAC ARREST
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
HYPERTENSIVE CARDIOMYOPATHY
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Eye disorders
RETINAL TEAR
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.0%
2/66 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.5%
3/66 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
NAUSEA
|
3.0%
2/66 • Number of events 2
|
3.0%
2/66 • Number of events 3
|
|
Gastrointestinal disorders
RECTAL PERFORATION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
1/66 • Number of events 1
|
3.0%
2/66 • Number of events 3
|
|
General disorders
ASTHENIA
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
General disorders
DISEASE PROGRESSION
|
12.1%
8/66 • Number of events 8
|
3.0%
2/66 • Number of events 2
|
|
General disorders
FATIGUE
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
General disorders
PAIN
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
General disorders
PYREXIA
|
3.0%
2/66 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
BACTERAEMIA
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
CELLULITIS
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
OSTEOMYELITIS
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
PNEUMONIA
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
EXPIRED DRUG ADMINISTERED
|
0.00%
0/66
|
4.5%
3/66 • Number of events 3
|
|
Injury, poisoning and procedural complications
INCORRECT DOSE ADMINISTERED
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.00%
0/66
|
6.1%
4/66 • Number of events 4
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
CACHEXIA
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.1%
4/66 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.5%
1/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.1%
4/66 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.5%
1/66 • Number of events 2
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
AUTONOMIC NEUROPATHY
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM MASS
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
PRESYNCOPE
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Nervous system disorders
SYNCOPE
|
4.5%
3/66 • Number of events 4
|
0.00%
0/66
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
VASOGENIC CEREBRAL OEDEMA
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Renal and urinary disorders
HAEMATURIA
|
3.0%
2/66 • Number of events 3
|
0.00%
0/66
|
|
Renal and urinary disorders
HAEMORRHAGE URINARY TRACT
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
PROTEINURIA
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Renal and urinary disorders
URINARY BLADDER HAEMORRHAGE
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/66
|
3.0%
2/66 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
3.0%
2/66 • Number of events 2
|
0.00%
0/66
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
3.0%
2/66 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.00%
0/66
|
1.5%
1/66 • Number of events 1
|
Other adverse events
| Measure |
IMC-A12 + Mitoxantrone + Prednisone
n=66 participants at risk
IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone
n=66 participants at risk
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m\^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
34.8%
23/66 • Number of events 42
|
34.8%
23/66 • Number of events 47
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
31.8%
21/66 • Number of events 36
|
22.7%
15/66 • Number of events 27
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
6.1%
4/66 • Number of events 8
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
42.4%
28/66 • Number of events 43
|
36.4%
24/66 • Number of events 43
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
18.2%
12/66 • Number of events 34
|
34.8%
23/66 • Number of events 51
|
|
Eye disorders
LACRIMATION INCREASED
|
7.6%
5/66 • Number of events 7
|
9.1%
6/66 • Number of events 6
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
7.6%
5/66 • Number of events 6
|
13.6%
9/66 • Number of events 12
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.5%
1/66 • Number of events 1
|
6.1%
4/66 • Number of events 4
|
|
Gastrointestinal disorders
CONSTIPATION
|
40.9%
27/66 • Number of events 38
|
36.4%
24/66 • Number of events 30
|
|
Gastrointestinal disorders
DIARRHOEA
|
43.9%
29/66 • Number of events 68
|
43.9%
29/66 • Number of events 55
|
|
Gastrointestinal disorders
DRY MOUTH
|
10.6%
7/66 • Number of events 7
|
12.1%
8/66 • Number of events 9
|
|
Gastrointestinal disorders
DYSPEPSIA
|
12.1%
8/66 • Number of events 8
|
10.6%
7/66 • Number of events 8
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
7.6%
5/66 • Number of events 5
|
4.5%
3/66 • Number of events 3
|
|
Gastrointestinal disorders
NAUSEA
|
51.5%
34/66 • Number of events 55
|
47.0%
31/66 • Number of events 56
|
|
Gastrointestinal disorders
STOMATITIS
|
10.6%
7/66 • Number of events 7
|
22.7%
15/66 • Number of events 18
|
|
Gastrointestinal disorders
VOMITING
|
27.3%
18/66 • Number of events 24
|
28.8%
19/66 • Number of events 31
|
|
General disorders
ASTHENIA
|
7.6%
5/66 • Number of events 5
|
18.2%
12/66 • Number of events 16
|
|
General disorders
CHILLS
|
6.1%
4/66 • Number of events 5
|
13.6%
9/66 • Number of events 9
|
|
General disorders
FATIGUE
|
72.7%
48/66 • Number of events 130
|
71.2%
47/66 • Number of events 97
|
|
General disorders
MUCOSAL INFLAMMATION
|
6.1%
4/66 • Number of events 5
|
6.1%
4/66 • Number of events 4
|
|
General disorders
OEDEMA PERIPHERAL
|
15.2%
10/66 • Number of events 13
|
21.2%
14/66 • Number of events 21
|
|
General disorders
PYREXIA
|
15.2%
10/66 • Number of events 11
|
16.7%
11/66 • Number of events 12
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.5%
3/66 • Number of events 4
|
15.2%
10/66 • Number of events 12
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.1%
8/66 • Number of events 9
|
6.1%
4/66 • Number of events 7
|
|
Injury, poisoning and procedural complications
FALL
|
6.1%
4/66 • Number of events 5
|
4.5%
3/66 • Number of events 3
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.1%
4/66 • Number of events 4
|
10.6%
7/66 • Number of events 7
|
|
Investigations
BLOOD CREATININE INCREASED
|
9.1%
6/66 • Number of events 13
|
3.0%
2/66 • Number of events 5
|
|
Investigations
EJECTION FRACTION DECREASED
|
9.1%
6/66 • Number of events 8
|
16.7%
11/66 • Number of events 13
|
|
Investigations
WEIGHT DECREASED
|
65.2%
43/66 • Number of events 94
|
60.6%
40/66 • Number of events 87
|
|
Metabolism and nutrition disorders
ANOREXIA
|
53.0%
35/66 • Number of events 56
|
47.0%
31/66 • Number of events 45
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
22.7%
15/66 • Number of events 19
|
6.1%
4/66 • Number of events 4
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
47.0%
31/66 • Number of events 64
|
12.1%
8/66 • Number of events 15
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
6.1%
4/66 • Number of events 10
|
6.1%
4/66 • Number of events 8
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
9.1%
6/66 • Number of events 7
|
6.1%
4/66 • Number of events 5
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
6.1%
4/66 • Number of events 4
|
13.6%
9/66 • Number of events 21
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.1%
4/66 • Number of events 4
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
24.2%
16/66 • Number of events 20
|
24.2%
16/66 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
19.7%
13/66 • Number of events 18
|
22.7%
15/66 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
6.1%
4/66 • Number of events 7
|
6.1%
4/66 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
7.6%
5/66 • Number of events 5
|
4.5%
3/66 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
4.5%
3/66 • Number of events 3
|
6.1%
4/66 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
19.7%
13/66 • Number of events 18
|
6.1%
4/66 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
10.6%
7/66 • Number of events 8
|
4.5%
3/66 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
7.6%
5/66 • Number of events 5
|
6.1%
4/66 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
13.6%
9/66 • Number of events 13
|
9.1%
6/66 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.6%
5/66 • Number of events 6
|
6.1%
4/66 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.1%
4/66 • Number of events 4
|
15.2%
10/66 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
6.1%
4/66 • Number of events 7
|
3.0%
2/66 • Number of events 5
|
|
Nervous system disorders
DIZZINESS
|
13.6%
9/66 • Number of events 13
|
18.2%
12/66 • Number of events 14
|
|
Nervous system disorders
DYSGEUSIA
|
18.2%
12/66 • Number of events 18
|
15.2%
10/66 • Number of events 11
|
|
Nervous system disorders
HEADACHE
|
3.0%
2/66 • Number of events 6
|
19.7%
13/66 • Number of events 18
|
|
Nervous system disorders
HYPOAESTHESIA
|
3.0%
2/66 • Number of events 4
|
6.1%
4/66 • Number of events 4
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
3.0%
2/66 • Number of events 6
|
9.1%
6/66 • Number of events 8
|
|
Nervous system disorders
PARAESTHESIA
|
1.5%
1/66 • Number of events 1
|
7.6%
5/66 • Number of events 5
|
|
Psychiatric disorders
INSOMNIA
|
7.6%
5/66 • Number of events 6
|
15.2%
10/66 • Number of events 11
|
|
Renal and urinary disorders
CHROMATURIA
|
7.6%
5/66 • Number of events 5
|
3.0%
2/66 • Number of events 2
|
|
Renal and urinary disorders
DYSURIA
|
4.5%
3/66 • Number of events 5
|
6.1%
4/66 • Number of events 4
|
|
Renal and urinary disorders
NOCTURIA
|
16.7%
11/66 • Number of events 12
|
7.6%
5/66 • Number of events 5
|
|
Renal and urinary disorders
POLLAKIURIA
|
3.0%
2/66 • Number of events 2
|
6.1%
4/66 • Number of events 4
|
|
Renal and urinary disorders
PROTEINURIA
|
4.5%
3/66 • Number of events 5
|
15.2%
10/66 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
19.7%
13/66 • Number of events 19
|
18.2%
12/66 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
3.0%
2/66 • Number of events 2
|
16.7%
11/66 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.2%
12/66 • Number of events 15
|
31.8%
21/66 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
4.5%
3/66 • Number of events 4
|
16.7%
11/66 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
10.6%
7/66 • Number of events 8
|
19.7%
13/66 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
1.5%
1/66 • Number of events 1
|
7.6%
5/66 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.1%
4/66 • Number of events 6
|
9.1%
6/66 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/66
|
6.1%
4/66 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
1.5%
1/66 • Number of events 1
|
6.1%
4/66 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.1%
6/66 • Number of events 6
|
3.0%
2/66 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
15.2%
10/66 • Number of events 11
|
24.2%
16/66 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
13.6%
9/66 • Number of events 16
|
4.5%
3/66 • Number of events 3
|
|
Vascular disorders
HYPERTENSION
|
7.6%
5/66 • Number of events 5
|
34.8%
23/66 • Number of events 28
|
|
Vascular disorders
HYPOTENSION
|
12.1%
8/66 • Number of events 8
|
7.6%
5/66 • Number of events 5
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
6.1%
4/66 • Number of events 5
|
3.0%
2/66 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER