Trial Outcomes & Findings for Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers (NCT NCT00409006)
NCT ID: NCT00409006
Last Updated: 2010-09-09
Results Overview
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Results posted on
2010-09-09
Participant Flow
86 participants entered study. 13 participants were screen failures. 73 participants (40 pemetrexed/cisplatin/gefitinib and 33 pemetrexed/cisplatin) were assigned to treatment. 3 participants did not receive study drug. These 16 participants (13 screen failures and 3 that did not receive drug) were not included in the analyses.
Participant milestones
| Measure |
Pemetrexed/Cisplatin/Gefitinib
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
31
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
20
|
12
|
Reasons for withdrawal
| Measure |
Pemetrexed/Cisplatin/Gefitinib
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Death
|
15
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
Baseline Characteristics
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
Baseline characteristics by cohort
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.6 years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 12.43 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
China
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
15 Units on a scale
n=5 Participants
|
9 Units on a scale
n=7 Participants
|
24 Units on a scale
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
24 Units on a scale
n=5 Participants
|
22 Units on a scale
n=7 Participants
|
46 Units on a scale
n=5 Participants
|
|
History of Smoking
Yes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of Smoking
No
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Basis of Diagnosis
Histopathological
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Basis of Diagnosis
Cytological
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Pathological Diagnosis
Mixed Cell Carcinoma, Lung
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Squamous Cell
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Pathological Diagnosis
Non-Small Cell Lung Carcinoma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Disease Stage
Stage IV
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to first observation of disease progression or death, 12 weeks up to 31 monthsPopulation: Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat \[ITT\] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Outcome measures
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
9.95 Months
Interval 5.85 to 16.49
|
6.83 Months
Interval 5.78 to 7.98
|
SECONDARY outcome
Timeframe: Baseline to measured response or death, 12 weeks up to 31 monthsPopulation: Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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 not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.
Outcome measures
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Tumor Response
|
18 Participants
Interval 30.1 to 62.8
|
11 Participants
Interval 19.2 to 54.6
|
SECONDARY outcome
Timeframe: Time of response to progressive disease or death, 12 weeks up to 31 monthsPopulation: Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).
The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) 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. A responder is a patient exhibiting a best overall study response of CR or PR.
Outcome measures
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=18 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=11 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response for Responders
|
12.29 Months
Interval 8.51 to 15.31
|
4.14 Months
Interval 2.76 to 7.62
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause, 12 weeks up to 31 monthsPopulation: Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline up to 31 monthsPopulation: Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.
This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.
Outcome measures
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 Participants
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants Who Died During the Study
|
35.9 Percentage of Participants
|
19.4 Percentage of Participants
|
Adverse Events
Pemetrexed/Cisplatin/Gefitinib
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Pemetrexed/Cisplatin
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 participants at risk
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 participants at risk
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Death
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Pyrexia
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Acute tonsillitis
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infection
|
0.00%
0/39
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Coma
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/39
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.6%
1/39 • Number of events 1
|
0.00%
0/31
|
Other adverse events
| Measure |
Pemetrexed/Cisplatin/Gefitinib
n=39 participants at risk
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
|
Pemetrexed/Cisplatin
n=31 participants at risk
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.8%
5/39 • Number of events 12
|
9.7%
3/31 • Number of events 5
|
|
Eye disorders
Dry eye
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Eye disorders
Vision blurred
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
1/39 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
3/39 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
2/39 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
17.9%
7/39 • Number of events 12
|
16.1%
5/31 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
25.6%
10/39 • Number of events 14
|
9.7%
3/31 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
6/39 • Number of events 7
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
69.2%
27/39 • Number of events 63
|
64.5%
20/31 • Number of events 45
|
|
Gastrointestinal disorders
Stomatitis
|
20.5%
8/39 • Number of events 13
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
12.8%
5/39 • Number of events 5
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
48.7%
19/39 • Number of events 52
|
48.4%
15/31 • Number of events 29
|
|
General disorders
Asthenia
|
7.7%
3/39 • Number of events 5
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Chest discomfort
|
2.6%
1/39 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Chest pain
|
10.3%
4/39 • Number of events 4
|
9.7%
3/31 • Number of events 7
|
|
General disorders
Fatigue
|
25.6%
10/39 • Number of events 20
|
16.1%
5/31 • Number of events 9
|
|
General disorders
Malaise
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
General disorders
Mucosal inflammation
|
5.1%
2/39 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
|
General disorders
Oedema peripheral
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Pyrexia
|
10.3%
4/39 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Cystitis
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Empyema
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Infections and infestations
Paronychia
|
10.3%
4/39 • Number of events 5
|
0.00%
0/31
|
|
Infections and infestations
Rhinitis
|
10.3%
4/39 • Number of events 6
|
0.00%
0/31
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
3/39 • Number of events 4
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
12.8%
5/39 • Number of events 6
|
19.4%
6/31 • Number of events 11
|
|
Investigations
Aspartate aminotransferase increased
|
12.8%
5/39 • Number of events 6
|
19.4%
6/31 • Number of events 7
|
|
Investigations
Creatinine renal clearance decreased
|
7.7%
3/39 • Number of events 3
|
12.9%
4/31 • Number of events 8
|
|
Investigations
Haemoglobin decreased
|
20.5%
8/39 • Number of events 8
|
35.5%
11/31 • Number of events 12
|
|
Investigations
Neutrophil count decreased
|
20.5%
8/39 • Number of events 14
|
41.9%
13/31 • Number of events 26
|
|
Investigations
Weight decreased
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Investigations
White blood cell count decreased
|
15.4%
6/39 • Number of events 9
|
25.8%
8/31 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
48.7%
19/39 • Number of events 35
|
48.4%
15/31 • Number of events 24
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/39
|
6.5%
2/31 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39
|
6.5%
2/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
2/39 • Number of events 3
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
7/39 • Number of events 8
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
2/39 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
3/39 • Number of events 3
|
3.2%
1/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
3/39 • Number of events 4
|
3.2%
1/31 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
15.4%
6/39 • Number of events 8
|
9.7%
3/31 • Number of events 4
|
|
Nervous system disorders
Headache
|
10.3%
4/39 • Number of events 6
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
1/39 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
6/39 • Number of events 8
|
6.5%
2/31 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • Number of events 3
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
23.1%
9/39 • Number of events 12
|
12.9%
4/31 • Number of events 7
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
9/39 • Number of events 11
|
12.9%
4/31 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
6/39 • Number of events 8
|
25.8%
8/31 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
3/39 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
3/39 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
1/39 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.7%
3/39 • Number of events 3
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
6/39 • Number of events 6
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
5.1%
2/39 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.9%
14/39 • Number of events 29
|
16.1%
5/31 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
13/39 • Number of events 21
|
19.4%
6/31 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
10.3%
4/39 • Number of events 4
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.1%
2/39 • Number of events 2
|
0.00%
0/31
|
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