Trial Outcomes & Findings for To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC) (NCT NCT00191191)
NCT ID: NCT00191191
Last Updated: 2009-12-09
Results Overview
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 3.2 years)
Results posted on
2009-12-09
Participant Flow
Baseline demographics and efficacy outcome measures are provided for the Full Analysis Set population (all randomized participants who met all inclusion and no exclusion criteria and received at least one dose of study drug).
Participant milestones
| Measure |
Pemetrexed 500 mg/m2
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
112
|
|
Overall Study
Safety Analysis Population
|
114
|
111
|
|
Overall Study
Full Analysis Set Population
|
108
|
108
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
114
|
112
|
Reasons for withdrawal
| Measure |
Pemetrexed 500 mg/m2
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Overall Study
Entry Criteria Exclusion
|
2
|
0
|
|
Overall Study
Treated with Another Systemic Agent
|
1
|
1
|
|
Overall Study
Adverse Event
|
11
|
21
|
|
Overall Study
Progressive Disease
|
84
|
72
|
|
Overall Study
Toxicity After Dose Reduction
|
7
|
8
|
|
Overall Study
Family/Caregiver Decision
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Good Clinical Practice Violation
|
0
|
1
|
Baseline Characteristics
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
108 participants
n=5 Participants
|
108 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
43 participants
n=5 Participants
|
36 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
59 participants
n=5 Participants
|
66 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory, No Work Activities
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Histological Types
Adenocarcinoma
|
77 participants
n=5 Participants
|
80 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Histological Types
Squamous Cell Carcinoma
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Histological Types
Large Cell Carcinoma
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Histological Types
Adenosquamous Carcinoma
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Histological Types
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Height
|
161.0 centimeters (cm)
STANDARD_DEVIATION 7.9 • n=5 Participants
|
161.1 centimeters (cm)
STANDARD_DEVIATION 8.7 • n=7 Participants
|
161.0 centimeters (cm)
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Weight
|
59.8 kilograms
STANDARD_DEVIATION 9.9 • n=5 Participants
|
59.1 kilograms
STANDARD_DEVIATION 11.9 • n=7 Participants
|
59.5 kilograms
STANDARD_DEVIATION 10.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 3.2 years)Population: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Best Overall Response
Stable Disease (SD)
|
40 participants
|
34 participants
|
|
Best Overall Response
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Best Overall Response
Partial Response (PR)
|
20 participants
|
16 participants
|
|
Best Overall Response
Progressive Disease (PD)
|
48 participants
|
58 participants
|
SECONDARY outcome
Timeframe: time of response to progressive disease (up to 3.2 years)Population: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
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.
Outcome measures
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Duration of Response
|
4.9 months
Interval 3.8 to 8.7
|
3.0 months
Interval 2.8 to 6.1
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 3.2 years)Population: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
Outcome measures
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.0 months
Interval 2.0 to 3.5
|
2.5 months
Interval 1.8 to 3.2
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), 3 Months after first dose of Cycle 1Population: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
Outcome measures
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Functional Change from Baseline (n=58, n=60)
|
-1.5 units on a scale
Standard Deviation 23.66
|
-3.7 units on a scale
Standard Deviation 19.99
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Functional Baseline (n=107, n=107)
|
77.0 units on a scale
Standard Deviation 24.81
|
75.0 units on a scale
Standard Deviation 26.18
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Physical Baseline (n=107, n=107)
|
78.9 units on a scale
Standard Deviation 18.02
|
73.9 units on a scale
Standard Deviation 21.06
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Physical Change from Baseline (n=58, n=60)
|
-1.6 units on a scale
Standard Deviation 18.27
|
-3.5 units on a scale
Standard Deviation 17.21
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Emotional Baseline (n=107, n=107)
|
67.2 units on a scale
Standard Deviation 20.21
|
62.1 units on a scale
Standard Deviation 23.29
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Emotional Change from Baseline (n=58, n=60)
|
-1.7 units on a scale
Standard Deviation 17.36
|
0.3 units on a scale
Standard Deviation 20.10
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Sociality Baseline (n=107, n=107)
|
45.9 units on a scale
Standard Deviation 22.09
|
46.1 units on a scale
Standard Deviation 22.37
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Sociality Change from Baseline (n=58, n=60)
|
1.6 units on a scale
Standard Deviation 12.26
|
1.6 units on a scale
Standard Deviation 17.05
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Face Scale Baseline (n=107, n=107)
|
59.3 units on a scale
Standard Deviation 20.75
|
59.3 units on a scale
Standard Deviation 25.12
|
|
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Face Scale Change from Baseline (n=58, n=60)
|
-1.3 units on a scale
Standard Deviation 20.64
|
-2.1 units on a scale
Standard Deviation 21.73
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), 3 Months after first dose of Cycle 1Population: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.
Outcome measures
| Measure |
Pemetrexed 500 mg/m2
n=108 Participants
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=108 Participants
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
Baseline (n=107, n=107)
|
71.5 units on a scale
Standard Deviation 18.81
|
69.6 units on a scale
Standard Deviation 18.52
|
|
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
Change from Baseline (n=58, n=60)
|
3.0 units on a scale
Standard Deviation 16.13
|
0.4 units on a scale
Standard Deviation 18.63
|
Adverse Events
Pemetrexed 500 mg/m2
Serious events: 19 serious events
Other events: 114 other events
Deaths: 0 deaths
Pemetrexed 1000 mg/m2
Serious events: 21 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed 500 mg/m2
n=114 participants at risk
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=111 participants at risk
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Malaise
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/114
|
4.5%
5/111 • Number of events 8
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.88%
1/114 • Number of events 1
|
1.8%
2/111 • Number of events 3
|
|
Infections and infestations
Pneumonia bacterial
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Sepsis
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/114
|
1.8%
2/111 • Number of events 2
|
|
Investigations
Oxygen saturation decreased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/114
|
1.8%
2/111 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.8%
2/114 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Dizziness
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Paralysis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Syncope
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Vocal cord paralysis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
5.3%
6/114 • Number of events 6
|
2.7%
3/111 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/114
|
1.8%
2/111 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/114
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Superior vena caval occlusion
|
0.88%
1/114 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed 500 mg/m2
n=114 participants at risk
Pemetrexed 500 mg/m2, intravenous, every 21 days
|
Pemetrexed 1000 mg/m2
n=111 participants at risk
Pemetrexed 1000 mg/m2, intravenous, every 21 days
|
|---|---|---|
|
General disorders
Malaise
|
40.4%
46/114 • Number of events 100
|
44.1%
49/111 • Number of events 92
|
|
General disorders
Oedema
|
5.3%
6/114 • Number of events 11
|
9.0%
10/111 • Number of events 11
|
|
General disorders
Oedema peripheral
|
6.1%
7/114 • Number of events 8
|
5.4%
6/111 • Number of events 7
|
|
General disorders
Pyrexia
|
30.7%
35/114 • Number of events 62
|
44.1%
49/111 • Number of events 97
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
14/114 • Number of events 18
|
12.6%
14/111 • Number of events 19
|
|
Investigations
Alanine aminotransferase increased
|
71.1%
81/114 • Number of events 227
|
73.9%
82/111 • Number of events 185
|
|
Investigations
Aspartate aminotransferase increased
|
77.2%
88/114 • Number of events 271
|
79.3%
88/111 • Number of events 254
|
|
Investigations
Blood albumin decreased
|
21.9%
25/114 • Number of events 53
|
39.6%
44/111 • Number of events 85
|
|
Investigations
Blood alkaline phosphatase increased
|
30.7%
35/114 • Number of events 51
|
31.5%
35/111 • Number of events 64
|
|
Investigations
Blood bilirubin increased
|
9.6%
11/114 • Number of events 22
|
17.1%
19/111 • Number of events 43
|
|
Investigations
Blood chloride decreased
|
6.1%
7/114 • Number of events 11
|
4.5%
5/111 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
6/114 • Number of events 9
|
1.8%
2/111 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
5/114 • Number of events 5
|
9.0%
10/111 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
24.6%
28/114 • Number of events 33
|
18.9%
21/111 • Number of events 31
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
16/114 • Number of events 23
|
13.5%
15/111 • Number of events 19
|
|
Gastrointestinal disorders
Nausea
|
56.1%
64/114 • Number of events 187
|
57.7%
64/111 • Number of events 133
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
9/114 • Number of events 12
|
11.7%
13/111 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting
|
28.9%
33/114 • Number of events 122
|
32.4%
36/111 • Number of events 54
|
|
General disorders
Chest pain
|
5.3%
6/114 • Number of events 7
|
2.7%
3/111 • Number of events 10
|
|
General disorders
Face oedema
|
5.3%
6/114 • Number of events 6
|
3.6%
4/111 • Number of events 5
|
|
General disorders
Fatigue
|
15.8%
18/114 • Number of events 35
|
16.2%
18/111 • Number of events 25
|
|
General disorders
Feeling hot
|
7.9%
9/114 • Number of events 13
|
10.8%
12/111 • Number of events 16
|
|
Investigations
Blood creatinine increased
|
9.6%
11/114 • Number of events 15
|
11.7%
13/111 • Number of events 25
|
|
Investigations
Blood glucose increased
|
19.3%
22/114 • Number of events 36
|
17.1%
19/111 • Number of events 42
|
|
Investigations
Blood lactate dehydrogenase increased
|
62.3%
71/114 • Number of events 182
|
64.0%
71/111 • Number of events 130
|
|
Investigations
Blood potassium decreased
|
2.6%
3/114 • Number of events 7
|
5.4%
6/111 • Number of events 18
|
|
Investigations
Blood potassium increased
|
3.5%
4/114 • Number of events 4
|
6.3%
7/111 • Number of events 15
|
|
Investigations
Blood pressure increased
|
3.5%
4/114 • Number of events 8
|
7.2%
8/111 • Number of events 12
|
|
Investigations
Blood sodium decreased
|
8.8%
10/114 • Number of events 11
|
9.0%
10/111 • Number of events 16
|
|
Investigations
Blood urea increased
|
10.5%
12/114 • Number of events 18
|
8.1%
9/111 • Number of events 22
|
|
Investigations
Blood urine present
|
17.5%
20/114 • Number of events 26
|
11.7%
13/111 • Number of events 27
|
|
Investigations
C-reactive protein increased
|
27.2%
31/114 • Number of events 96
|
36.9%
41/111 • Number of events 102
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.8%
10/114 • Number of events 11
|
9.9%
11/111 • Number of events 16
|
|
Investigations
Glucose urine present
|
9.6%
11/114 • Number of events 20
|
7.2%
8/111 • Number of events 21
|
|
Investigations
Haemoglobin decreased
|
51.8%
59/114 • Number of events 133
|
61.3%
68/111 • Number of events 152
|
|
Investigations
Lymphocyte count decreased
|
49.1%
56/114 • Number of events 109
|
57.7%
64/111 • Number of events 163
|
|
Investigations
Neutrophil count decreased
|
64.0%
73/114 • Number of events 280
|
66.7%
74/111 • Number of events 256
|
|
Investigations
Neutrophil count increased
|
19.3%
22/114 • Number of events 38
|
33.3%
37/111 • Number of events 84
|
|
Investigations
Platelet count decreased
|
47.4%
54/114 • Number of events 170
|
45.9%
51/111 • Number of events 145
|
|
Investigations
Platelet count increased
|
13.2%
15/114 • Number of events 52
|
10.8%
12/111 • Number of events 43
|
|
Investigations
Protein total decreased
|
10.5%
12/114 • Number of events 22
|
18.0%
20/111 • Number of events 28
|
|
Investigations
Protein urine present
|
15.8%
18/114 • Number of events 27
|
14.4%
16/111 • Number of events 27
|
|
Investigations
Red blood cell count decreased
|
40.4%
46/114 • Number of events 109
|
40.5%
45/111 • Number of events 82
|
|
Investigations
Urobilin urine present
|
4.4%
5/114 • Number of events 5
|
5.4%
6/111 • Number of events 9
|
|
Investigations
Weight decreased
|
17.5%
20/114 • Number of events 20
|
27.0%
30/111 • Number of events 34
|
|
Investigations
White blood cell count decreased
|
70.2%
80/114 • Number of events 287
|
73.0%
81/111 • Number of events 274
|
|
Investigations
White blood cell count increased
|
23.7%
27/114 • Number of events 49
|
33.3%
37/111 • Number of events 83
|
|
Metabolism and nutrition disorders
Anorexia
|
49.1%
56/114 • Number of events 149
|
68.5%
76/111 • Number of events 157
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
7/114 • Number of events 8
|
9.0%
10/111 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
8/114 • Number of events 17
|
4.5%
5/111 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
9/114 • Number of events 10
|
6.3%
7/111 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
6/114 • Number of events 6
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
17.5%
20/114 • Number of events 24
|
13.5%
15/111 • Number of events 15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
4.4%
5/114 • Number of events 11
|
9.9%
11/111 • Number of events 24
|
|
Nervous system disorders
Dizziness
|
7.0%
8/114 • Number of events 12
|
7.2%
8/111 • Number of events 9
|
|
Nervous system disorders
Dysgeusia
|
3.5%
4/114 • Number of events 7
|
6.3%
7/111 • Number of events 12
|
|
Nervous system disorders
Headache
|
14.0%
16/114 • Number of events 24
|
16.2%
18/111 • Number of events 29
|
|
Nervous system disorders
Hypoaesthesia
|
7.0%
8/114 • Number of events 8
|
4.5%
5/111 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
10.5%
12/114 • Number of events 13
|
10.8%
12/111 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.6%
28/114 • Number of events 31
|
14.4%
16/111 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
12/114 • Number of events 13
|
11.7%
13/111 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
2/114 • Number of events 4
|
6.3%
7/111 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.8%
10/114 • Number of events 12
|
6.3%
7/111 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.5%
4/114 • Number of events 8
|
7.2%
8/111 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
6/114 • Number of events 6
|
7.2%
8/111 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.0%
8/114 • Number of events 9
|
7.2%
8/111 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.6%
11/114 • Number of events 13
|
7.2%
8/111 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.9%
9/114 • Number of events 9
|
8.1%
9/111 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
7.0%
8/114 • Number of events 8
|
3.6%
4/111 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.3%
14/114 • Number of events 19
|
11.7%
13/111 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Rash
|
69.3%
79/114 • Number of events 128
|
78.4%
87/111 • Number of events 134
|
|
Vascular disorders
Hot flush
|
4.4%
5/114 • Number of events 6
|
6.3%
7/111 • Number of events 10
|
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