Trial Outcomes & Findings for Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00402051)
NCT ID: NCT00402051
Last Updated: 2010-02-17
Results Overview
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 \* exp(-6 λ) \* (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln\[ r / ∑ti \] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Randomization to Month 6
Results posted on
2010-02-17
Participant Flow
136 patients signed informed consent. Of these, 3 patients were discontinued prior to randomization (1x protocol entry criteria not met, 2x patient decision); 133 patients were randomized, 130 patients started study drug.
Participant milestones
| Measure |
Pemetrexed + Cisplatin
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
|
Overall Study
Received Treatment
|
65
|
65
|
|
Overall Study
COMPLETED
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
38
|
35
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Overall Study
Progressive Disease
|
13
|
20
|
|
Overall Study
Adverse Event
|
11
|
4
|
|
Overall Study
Physician Decision
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Death - Related to Study Drug
|
1
|
2
|
|
Overall Study
Death Due to Study Disease
|
2
|
1
|
|
Overall Study
Death Due to Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.3 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 7.51 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 7.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
40 participants
n=5 Participants
|
45 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
25 participants
n=5 Participants
|
20 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Histopathology
Squamous Cell Carcinoma
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Histopathology
Adenocarcinoma
|
38 participants
n=5 Participants
|
44 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Histopathology
Large Cell Carcinoma
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Histopathology
Mixed Cell Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Histopathology
Bronchioalveolar Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Histopathology
NSCLC, Not Otherwise Specified
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Presence of Bone and Brain Metastases
Bone Metastases
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Presence of Bone and Brain Metastases
Brain Metastases
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Smoking Status
Past Smoker
|
41 participants
n=5 Participants
|
42 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Stage of disease
Stage IIIb (locally advanced disease)
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Stage of disease
Stage IV (metastatic disease)
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Time Since Patient Stopped Smoking
|
10.1 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Use of Tobacco Products
|
31.7 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 11.47 • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Month 6Population: Full Analysis Set: All patients randomized who received at least one dose of study drug
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 \* exp(-6 λ) \* (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln\[ r / ∑ti \] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
|
52.8 percentage
Interval 40.3 to 65.3
|
39.3 percentage
Interval 27.8 to 50.8
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause (up to 1 year)Population: Full Analysis Set: All patients randomized who received at least one dose of study drug
Defined as the time from randomization to the date of death from any cause.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Overall Survival
|
11.7 months
Interval 9.2 to 14.9
|
8.9 months
Interval 6.0 to 12.2
|
SECONDARY outcome
Timeframe: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progressionPopulation: Full Analysis Set: All patients randomized who received at least one dose of study drug
Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Number of Participants With Tumor Response (as Basis for Response Rate)
Partial Response
|
21 participants
|
13 participants
|
|
Number of Participants With Tumor Response (as Basis for Response Rate)
Stable Disease
|
31 participants
|
32 participants
|
|
Number of Participants With Tumor Response (as Basis for Response Rate)
Disease Progression
|
7 participants
|
15 participants
|
|
Number of Participants With Tumor Response (as Basis for Response Rate)
Unknown/Not Done
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)Population: Full Analysis Set: All patients randomized who received at least one dose of study drug
Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
3.0 months
Interval 2.3 to 4.6
|
3.4 months
Interval 2.3 to 4.8
|
SECONDARY outcome
Timeframe: Every 21-day cycle for up to 6 cyclesPopulation: Full Analysis Set: All patients randomized who received at least one dose of study drug
Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 Participants
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Pharmacology Toxicities
Any Grade 3/4 Toxicity
|
29 participants
|
36 participants
|
|
Pharmacology Toxicities
Grade 3/4 Leucopenia
|
8 participants
|
12 participants
|
|
Pharmacology Toxicities
Grade 3/4 Neutropenia
|
11 participants
|
17 participants
|
|
Pharmacology Toxicities
Grade 3/4 Anemia
|
5 participants
|
7 participants
|
|
Pharmacology Toxicities
Grade 3/4 Thrombocytopenia
|
2 participants
|
11 participants
|
|
Pharmacology Toxicities
Grade 3/4 Nausea
|
3 participants
|
5 participants
|
|
Pharmacology Toxicities
Grade 3/4 Vomiting
|
2 participants
|
1 participants
|
|
Pharmacology Toxicities
Grade 3/4 Fatigue
|
2 participants
|
2 participants
|
|
Pharmacology Toxicities
Grade 3/4 Anorexia
|
1 participants
|
2 participants
|
|
Pharmacology Toxicities
Grade 3/4 Urinary Tract Infection
|
0 participants
|
2 participants
|
Adverse Events
Pemetrexed + Cisplatin
Serious events: 22 serious events
Other events: 61 other events
Deaths: 0 deaths
Pemetrexed + Carboplatin
Serious events: 28 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Cisplatin
n=65 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
3/65 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 2
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/65
|
7.7%
5/65 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/65 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Cardiac disorders
Cardiovascular disorder
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
|
General disorders
Chest pain
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
General physical health deterioration
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Multi-organ failure
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
General disorders
Pain
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
General disorders
Performance status decreased
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Cerebral fungal infection
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.6%
3/65 • Number of events 3
|
3.1%
2/65 • Number of events 3
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Grand mal convulsion
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
3.1%
2/65 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/65
|
4.6%
3/65 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/65
|
1.5%
1/65 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/65
|
3.1%
2/65 • Number of events 2
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin
n=65 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
|
Pemetrexed + Carboplatin
n=65 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.5%
12/65 • Number of events 13
|
29.2%
19/65 • Number of events 27
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
6.2%
4/65 • Number of events 4
|
18.5%
12/65 • Number of events 13
|
|
Blood and lymphatic system disorders
Leukopenia
|
26.2%
17/65 • Number of events 27
|
36.9%
24/65 • Number of events 41
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.7%
18/65 • Number of events 27
|
38.5%
25/65 • Number of events 62
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.8%
9/65 • Number of events 12
|
27.7%
18/65 • Number of events 39
|
|
Eye disorders
Conjunctivitis
|
7.7%
5/65 • Number of events 5
|
3.1%
2/65 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
9.2%
6/65 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
26.2%
17/65 • Number of events 18
|
16.9%
11/65 • Number of events 13
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
10/65 • Number of events 12
|
15.4%
10/65 • Number of events 13
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
4/65 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
64.6%
42/65 • Number of events 77
|
41.5%
27/65 • Number of events 46
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
5/65 • Number of events 5
|
0.00%
0/65
|
|
Gastrointestinal disorders
Vomiting
|
36.9%
24/65 • Number of events 31
|
12.3%
8/65 • Number of events 10
|
|
General disorders
Fatigue
|
38.5%
25/65 • Number of events 30
|
36.9%
24/65 • Number of events 31
|
|
General disorders
Mucosal inflammation
|
7.7%
5/65 • Number of events 5
|
7.7%
5/65 • Number of events 9
|
|
General disorders
Oedema peripheral
|
9.2%
6/65 • Number of events 6
|
4.6%
3/65 • Number of events 3
|
|
Infections and infestations
Infection
|
9.2%
6/65 • Number of events 7
|
6.2%
4/65 • Number of events 5
|
|
Infections and infestations
Rhinitis
|
3.1%
2/65 • Number of events 2
|
10.8%
7/65 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/65
|
6.2%
4/65 • Number of events 4
|
|
Investigations
Blood creatinine increased
|
7.7%
5/65 • Number of events 5
|
3.1%
2/65 • Number of events 3
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/65
|
7.7%
5/65 • Number of events 5
|
|
Investigations
Weight decreased
|
4.6%
3/65 • Number of events 3
|
12.3%
8/65 • Number of events 9
|
|
Metabolism and nutrition disorders
Anorexia
|
24.6%
16/65 • Number of events 21
|
15.4%
10/65 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
4/65 • Number of events 5
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
4/65 • Number of events 4
|
4.6%
3/65 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
4/65 • Number of events 6
|
6.2%
4/65 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
10.8%
7/65 • Number of events 9
|
4.6%
3/65 • Number of events 6
|
|
Nervous system disorders
Headache
|
10.8%
7/65 • Number of events 9
|
7.7%
5/65 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
7.7%
5/65 • Number of events 5
|
10.8%
7/65 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
4/65 • Number of events 4
|
12.3%
8/65 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
13/65 • Number of events 13
|
15.4%
10/65 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
5/65 • Number of events 5
|
7.7%
5/65 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.2%
6/65 • Number of events 6
|
9.2%
6/65 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
2/65 • Number of events 2
|
6.2%
4/65 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
3/65 • Number of events 3
|
7.7%
5/65 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
3/65 • Number of events 4
|
6.2%
4/65 • Number of events 7
|
|
Vascular disorders
Hypertension
|
6.2%
4/65 • Number of events 4
|
0.00%
0/65
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60