Trial Outcomes & Findings for A Study of LY573636-sodium in Patients With Metastatic Breast Cancer (NCT NCT00992225)
NCT ID: NCT00992225
Last Updated: 2018-07-17
Results Overview
Objective overall 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 disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Baseline to measured progressive disease or death from any cause up to 12 months
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
LY573636-sodium
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
Received at Least One Dose of Study Drug
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
LY573636-sodium
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Overall Study
Entry Criteria Not Met
|
8
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A Study of LY573636-sodium in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
LY573636-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully active
|
10 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, restricted strenuous activity
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured progressive disease or death from any cause up to 12 monthsPopulation: All participants who received at least one dose of study drug.
Objective overall 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 disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It 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-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Percentage of Participants With an Objective Overall Response
|
6.1 percentage of participants
Interval 1.1 to 17.9
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or death from any cause up to 12 monthsPopulation: All participants who received at least 1 dose of the 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 RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Progression-free Survival
|
1.81 months
Interval 1.64 to 2.17
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or death from any cause up to 12 monthsPopulation: All participants who received at least one dose of the study drug.
Clinical Benefit Rate = \[(CR) + (PR) + Stable Disease (SD)\] of at least 4 cycles/N as classified by the investigator according to the RECIST guidelines, where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
LY573636-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]
|
9.1 percentage of participants
Interval 0.9 to 17.3
|
SECONDARY outcome
Timeframe: Time of response to progressive disease or death up to 12 monthsPopulation: Zero participants analyzed. Duration of Overall Response for CR and PR data was not collected for analysis.
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 or death as a result of any cause. CR or PR is classified by the investigators according to RECIST guidelines. 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 (SD) to first date of progressive disease or death from any cause up to 12 monthsPopulation: All participants who received at least one dose of the study drug.
Duration of stable disease (SD) is defined from date of documented SD to first date of progressive disease (PD) or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy). SD is neither sufficient shrinkage to qualify for 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-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Duration of Stable Disease
|
3.52 months
Interval 3.45 to 3.98
|
SECONDARY outcome
Timeframe: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)Population: All participants who received at least one dose of the study drug.
Exposure is the amount of drug the body sees in a period of time. Target range is an exposure thought to offer the optimal balance of safety and efficacy based on prior research.
Outcome measures
| Measure |
LY573636-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
The Percentage of Participants With Exposures in the Target Range
Cycle 1
|
45 Percentage of participants
|
|
The Percentage of Participants With Exposures in the Target Range
Cycle 2
|
52 Percentage of participants
|
SECONDARY outcome
Timeframe: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]Population: All participants who received at least one dose of the study drug.
Outcome measures
| Measure |
LY573636-sodium
n=33 Participants
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Maximum Concentration (Cmax)
Cycle 1
|
375 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 16.4
|
|
Maximum Concentration (Cmax)
Cycle 2
|
339 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 17.2
|
Adverse Events
LY573636-sodium
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY573636-sodium
n=33 participants at risk
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Ileus
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Pain
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Aphasia
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Convulsion
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Vascular disorders
Deep vein thrombosis
|
3.0%
1/33 • Number of events 1
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
Other adverse events
| Measure |
LY573636-sodium
n=33 participants at risk
Dose was adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation were met
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
5/33 • Number of events 6
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
3/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
3/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
6/33 • Number of events 7
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
11/33 • Number of events 11
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Nausea
|
30.3%
10/33 • Number of events 11
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
5/33 • Number of events 6
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Chest pain
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Fatigue
|
63.6%
21/33 • Number of events 23
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Mucosal inflammation
|
6.1%
2/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Oedema peripheral
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Pain
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
General disorders
Pyrexia
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Infections and infestations
Sinusitis
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Infections and infestations
Urinary tract infection
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Alanine aminotransferase increased
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
3/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.2%
5/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Blood creatinine increased
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Urine colour abnormal
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Investigations
Weight decreased
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.2%
8/33 • Number of events 8
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
3/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
2/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.2%
5/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Dysgeusia
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Headache
|
12.1%
4/33 • Number of events 4
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.2%
6/33 • Number of events 6
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Renal and urinary disorders
Renal failure
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.2%
7/33 • Number of events 7
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Number of events 5
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Vascular disorders
Deep vein thrombosis
|
9.1%
3/33 • Number of events 3
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Number of events 2
Adverse events (AEs) provided for all participants who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
|
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