Trial Outcomes & Findings for A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer (NCT NCT01005680)
NCT ID: NCT01005680
Last Updated: 2013-12-13
Results Overview
OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.
COMPLETED
PHASE3
256 participants
Randomization to date of death from any cause up to 35.8 months post-randomization
2013-12-13
Participant Flow
Participant milestones
| Measure |
Pemetrexed Plus Cisplatin (PC)
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
130
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
125
|
127
|
|
Overall Study
COMPLETED
|
120
|
119
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
Pemetrexed Plus Cisplatin (PC)
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=126 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=130 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.6 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
256 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
126 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
126 participants
n=5 Participants
|
130 participants
n=7 Participants
|
256 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to date of death from any cause up to 35.8 months post-randomizationPopulation: Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.
OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=126 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=130 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Overall Survival (OS)
|
17.54 months
Interval 13.34 to 22.67
|
15.51 months
Interval 13.7 to 19.29
|
SECONDARY outcome
Timeframe: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomizationPopulation: Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.
PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=126 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=130 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Progression Free Survival (PFS)
|
5.88 months
Interval 4.99 to 6.47
|
5.85 months
Interval 5.59 to 6.41
|
SECONDARY outcome
Timeframe: Randomization to first date of PD up to 23.7 months post-randomizationPopulation: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.
TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=126 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=130 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Time to Progressive Disease (TtPD)
|
5.82 months
Interval 4.76 to 6.47
|
5.82 months
Interval 5.55 to 6.34
|
SECONDARY outcome
Timeframe: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomizationPopulation: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.
DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=30 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=24 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Duration of Response (DoR)
|
4.53 months
Interval 4.17 to 5.88
|
4.98 months
Interval 3.55 to 6.41
|
SECONDARY outcome
Timeframe: Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomizationPopulation: Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.
TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=126 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=130 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Time to Treatment Failure (TtTF)
|
NA months
Results were not calculable due to high censoring rate.
|
NA months
Results were not calculable due to high censoring rate.
|
SECONDARY outcome
Timeframe: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomizationPopulation: Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.
Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=121 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=116 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Tumor Response Rate
|
24.8 percentage of participants
|
20.7 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause up to 35.8 months post-randomizationPopulation: Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.
Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=125 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=127 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Risk/Benefit Ratio
|
0.70 ratio
|
0.83 ratio
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomizationPopulation: Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.
DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=121 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=116 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Disease Control Rate (DCR)
|
78.5 percentage of participants
|
75.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to date of toxicity or date of death up to 34.6 months post-randomizationPopulation: Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.
SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=125 Participants
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=127 Participants
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
|
|---|---|---|
|
Survival Without Toxicity (SWT)
|
5.85 months
Interval 4.21 to 8.38
|
2.56 months
Interval 1.68 to 3.78
|
Adverse Events
Pemetrexed Plus Cisplatin (PC)
Gemcitabine Plus Cisplatin (GC)
Serious adverse events
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=125 participants at risk
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=127 participants at risk
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/125
|
1.6%
2/127 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
General disorders
Fatigue
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
General disorders
Pyrexia
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
Infections and infestations
Lung infection
|
1.6%
2/125 • Number of events 2
|
0.00%
0/127
|
|
Investigations
Neutrophil count decreased
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
1/125 • Number of events 1
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
1/125 • Number of events 1
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Embolism venous
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/125
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/127
|
|
Vascular disorders
Venous thrombosis limb
|
1.6%
2/125 • Number of events 3
|
0.00%
0/127
|
Other adverse events
| Measure |
Pemetrexed Plus Cisplatin (PC)
n=125 participants at risk
Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles
|
Gemcitabine Plus Cisplatin (GC)
n=127 participants at risk
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.4%
28/125 • Number of events 32
|
34.6%
44/127 • Number of events 54
|
|
Blood and lymphatic system disorders
Leukopenia
|
42.4%
53/125 • Number of events 101
|
47.2%
60/127 • Number of events 142
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.4%
8/125 • Number of events 11
|
6.3%
8/127 • Number of events 10
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.6%
52/125 • Number of events 122
|
51.2%
65/127 • Number of events 148
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.0%
10/125 • Number of events 18
|
10.2%
13/127 • Number of events 23
|
|
Gastrointestinal disorders
Constipation
|
16.8%
21/125 • Number of events 29
|
25.2%
32/127 • Number of events 47
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
9/125 • Number of events 9
|
6.3%
8/127 • Number of events 10
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
6/125 • Number of events 9
|
6.3%
8/127 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
44.8%
56/125 • Number of events 132
|
46.5%
59/127 • Number of events 131
|
|
Gastrointestinal disorders
Vomiting
|
35.2%
44/125 • Number of events 95
|
42.5%
54/127 • Number of events 88
|
|
General disorders
Fatigue
|
26.4%
33/125 • Number of events 66
|
26.0%
33/127 • Number of events 55
|
|
General disorders
Pyrexia
|
8.0%
10/125 • Number of events 10
|
7.1%
9/127 • Number of events 10
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
25/125 • Number of events 36
|
18.9%
24/127 • Number of events 32
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
20/125 • Number of events 27
|
10.2%
13/127 • Number of events 20
|
|
Investigations
Blood creatinine increased
|
4.0%
5/125 • Number of events 6
|
5.5%
7/127 • Number of events 9
|
|
Investigations
Blood sodium decreased
|
8.0%
10/125 • Number of events 16
|
8.7%
11/127 • Number of events 14
|
|
Investigations
Haemoglobin decreased
|
16.8%
21/125 • Number of events 24
|
26.0%
33/127 • Number of events 47
|
|
Investigations
Neutrophil count decreased
|
22.4%
28/125 • Number of events 69
|
23.6%
30/127 • Number of events 68
|
|
Investigations
Platelet count decreased
|
3.2%
4/125 • Number of events 4
|
12.6%
16/127 • Number of events 28
|
|
Investigations
Red blood cell count decreased
|
4.0%
5/125 • Number of events 8
|
5.5%
7/127 • Number of events 8
|
|
Investigations
White blood cell count decreased
|
20.0%
25/125 • Number of events 59
|
25.2%
32/127 • Number of events 68
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.8%
46/125 • Number of events 88
|
30.7%
39/127 • Number of events 67
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.6%
12/125 • Number of events 14
|
7.9%
10/127 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.6%
17/125 • Number of events 21
|
5.5%
7/127 • Number of events 11
|
|
Nervous system disorders
Dizziness
|
6.4%
8/125 • Number of events 13
|
3.9%
5/127 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
5.6%
7/125 • Number of events 7
|
7.1%
9/127 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
7/125 • Number of events 8
|
6.3%
8/127 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
4/125 • Number of events 4
|
11.8%
15/127 • Number of events 20
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60