Trial Outcomes & Findings for Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00370292)
NCT ID: NCT00370292
Last Updated: 2009-10-20
Results Overview
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Results posted on
2009-10-20
Participant Flow
Of the 19 enrolled patients, 12 were enrolled before the protocol amendment was made effective (i.e. 2-weekly administration) and 7 were enrolled after the amendment (i.e. 3-weekly administration).
Participant milestones
| Measure |
Pemetrexed
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Pemetrexed
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
|
|---|---|
|
Overall Study
Disease Progression
|
4
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed - Before Amendment
n=12 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
|
Pemetrexed - After Amendment
n=7 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69.1 years
STANDARD_DEVIATION 10.34 • n=99 Participants
|
69.4 years
STANDARD_DEVIATION 6.45 • n=107 Participants
|
69.2 years
STANDARD_DEVIATION 8.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=99 Participants
|
7 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Disease Stages
Not Known
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Stages
Stage IA
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Disease Stages
Stage IB
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Stages
Stage IIA
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Stages
Stage IIB
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Stages
Stage IIIA
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Disease Stages
Stage IIIB
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Disease Stages
Stage IV
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0 - Fully Active
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2 - Ambulatory, No Work Activities
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Histopathological Grade
Not Done
|
7 participants
n=99 Participants
|
2 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Histopathological Grade
G1 - Well-Differentiated
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Histopathological Grade
G2 - Moderately Differentiated
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Histopathological Grade
G3 - Poorly Differentiated
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Previous Anti-Tumor Treatment
No
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Previous Anti-Tumor Treatment
Yes
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Previous Surgery
Surgery - No
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Previous Surgery
Surgery - Yes: Pneumonectomy
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Previous Surgery
Surgery - Yes: Lobectomy
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Previous Surgery
Surgery - Yes: Other
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Previous Surgery
Surgery - Yes: Radical
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity
Caucasian
|
12 participants
n=99 Participants
|
7 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Tumor Type
Adenocarcinoma
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Tumor Type
Squamous Cell Carcinoma
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Tumor Type
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Blood Pressure
Systolic Blood Pressure (SBP)
|
138.0 mmHg
STANDARD_DEVIATION 13.17 • n=99 Participants
|
146.9 mmHg
STANDARD_DEVIATION 21.54 • n=107 Participants
|
141.6 mmHg
STANDARD_DEVIATION 17.08 • n=206 Participants
|
|
Blood Pressure
Diastolic Blood Pressure (DBP)
|
81.8 mmHg
STANDARD_DEVIATION 7.97 • n=99 Participants
|
83.6 mmHg
STANDARD_DEVIATION 9.45 • n=107 Participants
|
82.5 mmHg
STANDARD_DEVIATION 8.37 • n=206 Participants
|
|
Body Surface Area (BSA)
|
1.7 square meters (m^2)
STANDARD_DEVIATION 0.17 • n=99 Participants
|
1.7 square meters (m^2)
STANDARD_DEVIATION 0.13 • n=107 Participants
|
1.7 square meters (m^2)
STANDARD_DEVIATION 0.16 • n=206 Participants
|
|
Body Temperature
|
36.1 degrees Celsius (°C)
STANDARD_DEVIATION 0.58 • n=99 Participants
|
35.9 degrees Celsius (°C)
STANDARD_DEVIATION 0.36 • n=107 Participants
|
36.0 degrees Celsius (°C)
STANDARD_DEVIATION 0.49 • n=206 Participants
|
|
Heart Rate
|
82.9 beats per minute (bpm)
STANDARD_DEVIATION 14.98 • n=99 Participants
|
78.6 beats per minute (bpm)
STANDARD_DEVIATION 8.52 • n=107 Participants
|
81.1 beats per minute (bpm)
STANDARD_DEVIATION 12.58 • n=206 Participants
|
|
Height
|
169.2 centimeters (cm)
STANDARD_DEVIATION 10.15 • n=99 Participants
|
162.1 centimeters (cm)
STANDARD_DEVIATION 9.04 • n=107 Participants
|
166.4 centimeters (cm)
STANDARD_DEVIATION 10.09 • n=206 Participants
|
|
Weight
|
70.2 kilograms (kg)
STANDARD_DEVIATION 15.28 • n=99 Participants
|
66.3 kilograms (kg)
STANDARD_DEVIATION 9.43 • n=107 Participants
|
68.7 kilograms (kg)
STANDARD_DEVIATION 13.13 • n=206 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)Population: All participants who received at least one dose of study drug.
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Outcome measures
| Measure |
dCK - Cycle 1
n=19 Participants
Mean dCK expression evaluated at Cycle 1.
|
dCK - Cycle 2
n=19 Participants
Mean dCK expression evaluated at Cycle 2.
|
dCK - Cycle 3
n=19 Participants
Mean dCK expression evaluated at Cycle 3.
|
|---|---|---|---|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
Pre-Dose
|
0.92 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.92 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.92 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
1 Hour Post-Dose
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.95 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
2 Hours Post-Dose
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.97 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
4 Hours Post-Dose
|
0.93 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.94 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.92 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
6 Hours Post-Dose
|
0.92 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
24 Hours Post-Dose
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.97 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
48 Hours Post-Dose
|
0.97 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.96 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.97 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)Population: Number of participants who received at least one dose of study drug.
dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Outcome measures
| Measure |
dCK - Cycle 1
n=19 Participants
Mean dCK expression evaluated at Cycle 1.
|
dCK - Cycle 2
n=19 Participants
Mean dCK expression evaluated at Cycle 2.
|
dCK - Cycle 3
n=19 Participants
Mean dCK expression evaluated at Cycle 3.
|
|---|---|---|---|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
Pre-Dose
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
0.87 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
1 Hour Post-Dose
|
0.88 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.89 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.90 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
2 Hours Post-Dose
|
0.88 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.90 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.90 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
4 Hours Post-Dose
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.88 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.05
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.03
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
6 Hours Post-Dose
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.86 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
24 Hours Post-Dose
|
0.89 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
|
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
48 Hours Post-Dose
|
0.90 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.04
|
0.91 mRNA relative values (ratio with GAPDH)
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: baseline to measured response (every 14 days for 6 cycles)Population: Number of participants who received at least one dose of study drug.
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 that do not meet above criteria.
Outcome measures
| Measure |
dCK - Cycle 1
n=12 Participants
Mean dCK expression evaluated at Cycle 1.
|
dCK - Cycle 2
n=7 Participants
Mean dCK expression evaluated at Cycle 2.
|
dCK - Cycle 3
Mean dCK expression evaluated at Cycle 3.
|
|---|---|---|---|
|
Best Objective Tumor Response
Partial Response
|
1 participants
|
0 participants
|
—
|
|
Best Objective Tumor Response
Stable Disease
|
2 participants
|
4 participants
|
—
|
|
Best Objective Tumor Response
Progressive Disease
|
3 participants
|
0 participants
|
—
|
|
Best Objective Tumor Response
Early Death
|
1 participants
|
0 participants
|
—
|
|
Best Objective Tumor Response
Unconfirmed Stable Disease
|
5 participants
|
3 participants
|
—
|
Adverse Events
Pemetrexed
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
n=19 participants at risk
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Disease progression
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=19 participants at risk
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.3%
5/19 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.8%
3/19 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.8%
3/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Petechiae
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
2/19 • Number of events 3
|
|
Cardiac disorders
Arrhythmia
|
15.8%
3/19 • Number of events 4
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.3%
1/19 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
31.6%
6/19 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
31.6%
6/19 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
5/19 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 3
|
|
Gastrointestinal disorders
Salivary gland calculus
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Number of events 7
|
|
General disorders
Asthenia
|
47.4%
9/19 • Number of events 13
|
|
General disorders
Chest pain
|
15.8%
3/19 • Number of events 7
|
|
General disorders
Fatigue
|
21.1%
4/19 • Number of events 4
|
|
General disorders
General physical health deterioration
|
15.8%
3/19 • Number of events 3
|
|
General disorders
Mucosal inflammation
|
42.1%
8/19 • Number of events 11
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Pyrexia
|
73.7%
14/19 • Number of events 27
|
|
Infections and infestations
Omphalitis
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Platelet count increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Transaminases
|
10.5%
2/19 • Number of events 3
|
|
Investigations
Transaminases increased
|
15.8%
3/19 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • Number of events 1
|
|
Reproductive system and breast disorders
Balanitis
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
5/19 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.8%
7/19 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
21.1%
4/19 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Epistaxis
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
5.3%
1/19 • Number of events 1
|
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