Trial Outcomes & Findings for Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer (NCT NCT00363766)
NCT ID: NCT00363766
Last Updated: 2018-10-19
Results Overview
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
First dose to measured progressive disease or death from study disease up to 10.35 months
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
LY573636 Target Cmax 420 µg/mL
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
20
|
Reasons for withdrawal
| Measure |
LY573636 Target Cmax 420 µg/mL
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
15
|
9
|
|
Overall Study
Adverse Event
|
10
|
2
|
|
Overall Study
Disease Related Death
|
1
|
3
|
|
Overall Study
Not Disease Related Death
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
Baseline Characteristics
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 7.90 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Pathological Diagnosis
Lung, Large Cell
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pathological Diagnosis
Poorly Differentiated Non-Small-Cell Lung Cancer
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pathological Diagnosis
Lung, Adenocarcinoma
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Pathological Diagnosis
Lung, Squamous Cell
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Pathological Diagnosis
Bronchoalveolar Carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose to measured progressive disease or death from study disease up to 10.35 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Time to Progression
|
3.12 months
Interval 2.04 to 4.21
|
1.64 months
Interval 1.35 to 5.19
|
SECONDARY outcome
Timeframe: First treatment dose to measured progressive disease or death from any cause up to 10.35 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
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 (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Progression-Free Survival
|
2.69 months
Interval 1.38 to 4.17
|
1.43 months
Interval 1.31 to 3.22
|
SECONDARY outcome
Timeframe: First treatment dose to measured progressive disease or death due to any cause up to 10.35 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). 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 |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)Population: Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=25 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 1
|
379.6 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 14.1
|
337.6 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 15.5
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 2
|
293.7 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 11.0
|
316.1 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 14.4
|
SECONDARY outcome
Timeframe: First treatment dose to death due to any cause up to 25.23 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Defined as the time from date of first dose to the date of death due to any cause.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Overall Survival Time
|
8.48 months
Interval 5.06 to 10.15
|
7.97 months
Interval 4.07 to 12.06
|
SECONDARY outcome
Timeframe: Time of response to progressive disease or death up to 10.35 monthsPopulation: Since there were zero participants with CR or PR, the duration of response could not be analyzed.
The duration of a 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 of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from documented stable disease or better to first date of progressive disease up to 10.35 monthsPopulation: All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.
Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=14 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=7 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Duration of Stable Disease
|
4.21 months
Interval 3.58 to 5.72
|
4.93 months
Interval 3.22 to 10.35
|
SECONDARY outcome
Timeframe: First treatment dose up to 25.23 monthsPopulation: All enrolled participants who received at least 1 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. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 Participants
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 Participants
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety)
Other Nonserious Adverse Events
|
30 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (Safety)
Serious Adverse Events
|
17 Participants
|
9 Participants
|
Adverse Events
LY573636 Target Cmax 420 µg/mL
Serious events: 17 serious events
Other events: 30 other events
Deaths: 0 deaths
LY573636 Target Cmax 380 µg/mL
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 participants at risk
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 participants at risk
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.6%
5/32 • Number of events 6
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
2/32 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
4/32 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.2%
10/32 • Number of events 11
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
Cardiac Arrest
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastrointestinal Toxicity
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Condition Aggravated
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pyrexia
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Hepatobiliary disorders
Cholangitis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Hepatobiliary disorders
Cholestasis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Hepatobiliary disorders
Jaundice
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Bronchitis Bacterial
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Gastroenteritis Viral
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Infection
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Lung Infection
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation Pneumonitis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • Number of events 3
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
2/32 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.2%
2/32 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypovolaemic Shock
|
3.1%
1/32 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Superior Vena Caval Occlusion
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
LY573636 Target Cmax 420 µg/mL
n=32 participants at risk
A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
LY573636 Target Cmax 380 µg/mL
n=20 participants at risk
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
6/32 • Number of events 6
|
15.0%
3/20 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
2/32 • Number of events 2
|
10.0%
2/20 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.9%
7/32 • Number of events 8
|
15.0%
3/20 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
8/32 • Number of events 11
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
9.4%
3/32 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.4%
3/32 • Number of events 3
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
25.0%
8/32 • Number of events 9
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
4/32 • Number of events 5
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
4/32 • Number of events 4
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3
|
15.0%
3/20 • Number of events 4
|
|
Gastrointestinal disorders
Oesophagitis
|
3.1%
1/32 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Tooth Disorder
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
5/32 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Asthenia
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chest Pain
|
12.5%
4/32 • Number of events 6
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Face Oedema
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
General disorders
Fatigue
|
34.4%
11/32 • Number of events 11
|
35.0%
7/20 • Number of events 7
|
|
General disorders
General Physical Health Deterioration
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
General disorders
Mucosal Inflammation
|
6.2%
2/32 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Oedema Peripheral
|
15.6%
5/32 • Number of events 8
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Pyrexia
|
18.8%
6/32 • Number of events 8
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Bronchitis Bacterial
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
6.2%
2/32 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
3/32 • Number of events 3
|
0.00%
0/20
|
|
Infections and infestations
Oral Candidiasis
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Mouth Injury
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 2
|
|
Investigations
Forced Expiratory Volume
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil Count
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Weight Decreased
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
15.6%
5/32 • Number of events 5
|
30.0%
6/20 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/32
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • Number of events 3
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
4/32 • Number of events 6
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.4%
3/32 • Number of events 3
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.6%
5/32 • Number of events 6
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
4/32 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • Number of events 3
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 5
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
6.2%
2/32 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Syncope
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Psychiatric disorders
Agitation
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Sleep Disorder
|
9.4%
3/32 • Number of events 3
|
0.00%
0/20
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
5/32 • Number of events 5
|
20.0%
4/20 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.6%
5/32 • Number of events 5
|
35.0%
7/20 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.6%
5/32 • Number of events 5
|
15.0%
3/20 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/32
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32 • Number of events 2
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
3.1%
1/32 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.1%
1/32 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.1%
1/32 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
3/32 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/32
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
3.1%
1/32 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
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