Trial Outcomes & Findings for Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC) (NCT NCT00191139)
NCT ID: NCT00191139
Last Updated: 2010-02-17
Results Overview
Percentage of participants alive at 2 years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
2 years
Results posted on
2010-02-17
Participant Flow
Participant milestones
| Measure |
Gemcitabine
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
| Measure |
Gemcitabine
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Disease Progression
|
0
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
China
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Eastern Oncology Cooperative Group (ECOG) Performance Status
0 - Fully Active
|
12 units on a scale
n=5 Participants
|
14 units on a scale
n=7 Participants
|
26 units on a scale
n=5 Participants
|
|
Eastern Oncology Cooperative Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
19 units on a scale
n=5 Participants
|
18 units on a scale
n=7 Participants
|
37 units on a scale
n=5 Participants
|
|
Eastern Oncology Cooperative Group (ECOG) Performance Status
2 - Ambulatory, No Work Activities
|
1 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
1 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Intention to treat (ITT) population
Percentage of participants alive at 2 years.
Outcome measures
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
2-Year Survival
|
40.6 percentage of participants
|
55.7 percentage of participants
|
SECONDARY outcome
Timeframe: randomization and every 3 months up to 2 years of post-study followupPopulation: ITT population
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).
Outcome measures
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Number of Patients With Overall Tumor Response
|
24 participants
|
27 participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease up to 2057 daysPopulation: ITT population
Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.
Outcome measures
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Progression-Free Survival
|
162.5 days
Interval 82.0 to 239.0
|
408.0 days
Interval 141.0 to 708.0
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause up to 2057 daysPopulation: ITT population
Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Overall Survival
|
492.5 days
Interval 299.0 to 1034.0
|
899.0 days
Interval 498.0 to 1583.0
|
SECONDARY outcome
Timeframe: baseline to 3 months after last dose of study treatment (three 21-day cycles)Population: as-treated population
LCSS measures physical \& functional dimensions. The patient scale contains 9 items, 3 summation \& 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.
Outcome measures
| Measure |
Gemcitabine
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 Participants
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
Improvement
|
8 participants
|
5 participants
|
|
Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
Stable
|
10 participants
|
9 participants
|
|
Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
Worse
|
2 participants
|
8 participants
|
Adverse Events
Gemcitabine
Serious events: 13 serious events
Other events: 32 other events
Deaths: 0 deaths
Gemcitabine Plus Docetaxel
Serious events: 18 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine
n=32 participants at risk
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 participants at risk
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.00%
0/32
|
12.5%
4/32 • Number of events 8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
2/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 6
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
Cardiac failure NOS
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Gastrointestinal disorders
Diverticulitis NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Oesophagitis NOS
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting NOS
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/32
|
3.1%
1/32 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Death NOS
|
6.2%
2/32 • Number of events 2
|
0.00%
0/32
|
|
General disorders
Fatigue
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Candidal infection NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Lung infection NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Pneumonia NOS
|
12.5%
4/32 • Number of events 5
|
15.6%
5/32 • Number of events 5
|
|
Infections and infestations
Sepsis NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/32
|
12.5%
4/32 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Convulsions NOS
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
3.1%
1/32 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Face oedema
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine
n=32 participants at risk
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
|
Gemcitabine Plus Docetaxel
n=32 participants at risk
Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
56.2%
18/32 • Number of events 26
|
75.0%
24/32 • Number of events 63
|
|
Blood and lymphatic system disorders
Erythropenia
|
6.2%
2/32 • Number of events 2
|
6.2%
2/32 • Number of events 4
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/32
|
9.4%
3/32 • Number of events 3
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
37.5%
12/32 • Number of events 41
|
40.6%
13/32 • Number of events 41
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
4/32 • Number of events 6
|
9.4%
3/32 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.4%
19/32 • Number of events 93
|
71.9%
23/32 • Number of events 73
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.1%
9/32 • Number of events 27
|
40.6%
13/32 • Number of events 33
|
|
Cardiac disorders
Tachycardia NOS
|
21.9%
7/32 • Number of events 8
|
15.6%
5/32 • Number of events 5
|
|
Ear and labyrinth disorders
Tinnitus
|
15.6%
5/32 • Number of events 5
|
9.4%
3/32 • Number of events 3
|
|
Eye disorders
Vision blurred
|
3.1%
1/32 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
6.2%
2/32 • Number of events 2
|
15.6%
5/32 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • Number of events 1
|
12.5%
4/32 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
40.6%
13/32 • Number of events 16
|
43.8%
14/32 • Number of events 25
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
28.1%
9/32 • Number of events 15
|
50.0%
16/32 • Number of events 22
|
|
Gastrointestinal disorders
Dyspepsia
|
15.6%
5/32 • Number of events 5
|
28.1%
9/32 • Number of events 13
|
|
Gastrointestinal disorders
Dysphagia
|
34.4%
11/32 • Number of events 15
|
40.6%
13/32 • Number of events 19
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32 • Number of events 2
|
0.00%
0/32
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
71.9%
23/32 • Number of events 54
|
87.5%
28/32 • Number of events 62
|
|
Gastrointestinal disorders
Odynophagia
|
9.4%
3/32 • Number of events 5
|
6.2%
2/32 • Number of events 3
|
|
Gastrointestinal disorders
Oesophagitis NOS
|
18.8%
6/32 • Number of events 11
|
28.1%
9/32 • Number of events 12
|
|
Gastrointestinal disorders
Stomatitis
|
9.4%
3/32 • Number of events 4
|
15.6%
5/32 • Number of events 7
|
|
Gastrointestinal disorders
Toothache
|
9.4%
3/32 • Number of events 3
|
0.00%
0/32
|
|
Gastrointestinal disorders
Vomiting NOS
|
53.1%
17/32 • Number of events 37
|
68.8%
22/32 • Number of events 47
|
|
General disorders
Asthenia
|
15.6%
5/32 • Number of events 5
|
15.6%
5/32 • Number of events 9
|
|
General disorders
Chest discomfort
|
6.2%
2/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Chest pain
|
18.8%
6/32 • Number of events 8
|
12.5%
4/32 • Number of events 5
|
|
General disorders
Fatigue
|
59.4%
19/32 • Number of events 34
|
81.2%
26/32 • Number of events 59
|
|
General disorders
Influenza like illness
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 3
|
|
General disorders
Oedema NOS
|
6.2%
2/32 • Number of events 2
|
9.4%
3/32 • Number of events 8
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • Number of events 1
|
12.5%
4/32 • Number of events 6
|
|
General disorders
Pain NOS
|
9.4%
3/32 • Number of events 3
|
6.2%
2/32 • Number of events 3
|
|
General disorders
Pyrexia
|
31.2%
10/32 • Number of events 20
|
43.8%
14/32 • Number of events 22
|
|
General disorders
Rigors
|
9.4%
3/32 • Number of events 4
|
21.9%
7/32 • Number of events 10
|
|
Immune system disorders
Drug hypersensitivity
|
9.4%
3/32 • Number of events 3
|
6.2%
2/32 • Number of events 4
|
|
Infections and infestations
Candidal infection NOS
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Lower respiratory tract infection NOS
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Pneumonia NOS
|
12.5%
4/32 • Number of events 4
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
6.2%
2/32 • Number of events 2
|
0.00%
0/32
|
|
Infections and infestations
Urinary tract infection NOS
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
12.5%
4/32 • Number of events 5
|
15.6%
5/32 • Number of events 5
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
12.5%
4/32 • Number of events 5
|
6.2%
2/32 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
3.1%
1/32 • Number of events 2
|
12.5%
4/32 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32
|
6.2%
2/32 • Number of events 5
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
2/32 • Number of events 5
|
6.2%
2/32 • Number of events 3
|
|
Investigations
Sputum increased
|
6.2%
2/32 • Number of events 3
|
0.00%
0/32
|
|
Investigations
Weight decreased
|
15.6%
5/32 • Number of events 5
|
12.5%
4/32 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
16/32 • Number of events 23
|
53.1%
17/32 • Number of events 31
|
|
Metabolism and nutrition disorders
Dehydration
|
15.6%
5/32 • Number of events 6
|
15.6%
5/32 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
9.4%
3/32 • Number of events 3
|
18.8%
6/32 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
1/32 • Number of events 5
|
9.4%
3/32 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.6%
5/32 • Number of events 10
|
9.4%
3/32 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
2/32 • Number of events 3
|
9.4%
3/32 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 3
|
18.8%
6/32 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/32
|
6.2%
2/32 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
2/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Local swelling
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 4
|
21.9%
7/32 • Number of events 8
|
|
Nervous system disorders
Ataxia
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 5
|
34.4%
11/32 • Number of events 15
|
|
Nervous system disorders
Dysgeusia
|
12.5%
4/32 • Number of events 5
|
21.9%
7/32 • Number of events 7
|
|
Nervous system disorders
Headache
|
21.9%
7/32 • Number of events 10
|
28.1%
9/32 • Number of events 10
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
6.2%
2/32 • Number of events 2
|
0.00%
0/32
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
2/32 • Number of events 4
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1
|
12.5%
4/32 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32
|
15.6%
5/32 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
21.9%
7/32 • Number of events 8
|
18.8%
6/32 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
53.1%
17/32 • Number of events 24
|
50.0%
16/32 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
43.8%
14/32 • Number of events 18
|
50.0%
16/32 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
2/32 • Number of events 2
|
12.5%
4/32 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
2/32 • Number of events 2
|
9.4%
3/32 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
4/32 • Number of events 4
|
21.9%
7/32 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
6.2%
2/32 • Number of events 2
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
2/32 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
14/32 • Number of events 16
|
62.5%
20/32 • Number of events 24
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.4%
3/32 • Number of events 4
|
9.4%
3/32 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
2/32 • Number of events 3
|
0.00%
0/32
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Number of events 2
|
6.2%
2/32 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
6.2%
2/32 • Number of events 6
|
9.4%
3/32 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
3.1%
1/32 • Number of events 1
|
12.5%
4/32 • Number of events 4
|
|
Vascular disorders
Hypotension NOS
|
12.5%
4/32 • Number of events 5
|
21.9%
7/32 • Number of events 10
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60