Trial Outcomes & Findings for A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer (NCT NCT01788566)
NCT ID: NCT01788566
Last Updated: 2016-06-27
Results Overview
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline to Measured Progressive Disease (up to 17 Months)
Results posted on
2016-06-27
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Cisplatin + Necitumumab
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Gemcitabine + Cisplatin + Necitumumab
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Clinical Progressive Disease
|
3
|
Baseline Characteristics
A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Measured Progressive Disease (up to 17 Months)Population: All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=54 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)
|
48.1 Percentage of participants
Interval 34.34 to 62.16
|
SECONDARY outcome
Timeframe: Baseline to Death from Any Cause (up to 17 Months)Population: All participants who received any amount of study treatment. Participants censored=34.
Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Overall Survival (OS)
|
11.7 months
Interval 7.59 to
The upper limit of the 95% confidence interval was not calculable due to the amount of censored data and immature survival data at the time of data cut-off.
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)Population: All participants who received any quantity of study treatment.
PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Progression Free Survival (PFS)
|
5.6 months
Interval 3.68 to 6.87
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)Population: All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.
DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)\*100.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=54 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
|
81.5 percentage of participants
Interval 68.57 to 90.75
|
SECONDARY outcome
Timeframe: Baseline until Measured Progressive Disease (up to 17 Months)Population: All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for CTS.
CTS is defined as maximum percent improvement from baseline in the sum of target lesions.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Percent Change in Tumor Size (CTS)
|
39.68 percent change
Standard Deviation 21.296
|
SECONDARY outcome
Timeframe: Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1Population: All participants who received any amount of study treatment and had evaluable data for Cmax
Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 1 Day 8
|
70.8 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 36.7
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 2 Day 1
|
67.5 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 78.0
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 3 Day 1
|
106 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 36.6
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 4 Day 1
|
115 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 43.9
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 5 Day 1
|
141 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 62.3
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 6 Day 1
|
126 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 34.2
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
EOI Cycle 1 Day 1
|
266 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 24.8
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
EOI Cycle 3 Day 1
|
352 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 29.5
|
|
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
EOI Cycle 5 Day 1
|
360 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 29.2
|
SECONDARY outcome
Timeframe: Baseline up to 30 Days Post Last Infusion (up to 17 Months)Population: All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for antibodies.
A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
Outcome measures
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 Participants
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Number of Participants With Anti-Necitumumab Antibodies
Number of Participants with 1 Positive Titer
|
9 participants
|
|
Number of Participants With Anti-Necitumumab Antibodies
Treatment Emergent Antibody Positive
|
4 participants
|
|
Number of Participants With Anti-Necitumumab Antibodies
Neutralizing Antibody Detected
|
3 participants
|
Adverse Events
Gemcitabine + Cisplatin + Necitumumab
Serious events: 33 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 participants at risk
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/61 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.9%
3/61 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/61 • Number of events 3
|
|
Cardiac disorders
Cardiac tamponade
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Gastric perforation
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Chest pain
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Fatigue
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Malaise
|
3.3%
2/61 • Number of events 3
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Catheter site abscess
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Clostridium difficile infection
|
1.6%
1/61 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/61 • Number of events 2
|
|
Infections and infestations
Neutropenic sepsis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.6%
4/61 • Number of events 4
|
|
Infections and infestations
Pneumonia haemophilus
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pulmonary radiation injury
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.3%
2/61 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
1.6%
1/61 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/61 • Number of events 1
|
|
Psychiatric disorders
Conduct disorder
|
1.6%
1/61 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
1.6%
1/61 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Aortic thrombosis
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/61 • Number of events 2
|
|
Vascular disorders
Superior vena cava syndrome
|
1.6%
1/61 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin + Necitumumab
n=61 participants at risk
Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.
Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.
Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
|
|---|---|
|
Vascular disorders
Hypertension
|
8.2%
5/61 • Number of events 5
|
|
Vascular disorders
Hypotension
|
4.9%
3/61 • Number of events 3
|
|
Vascular disorders
Jugular vein distension
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Jugular vein thrombosis
|
3.3%
2/61 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
3.3%
2/61 • Number of events 2
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Peripheral venous disease
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Raynaud's phenomenon
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
3.3%
2/61 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
24.6%
15/61 • Number of events 38
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.9%
3/61 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.1%
19/61 • Number of events 51
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.4%
10/61 • Number of events 20
|
|
Cardiac disorders
Myocardial ischaemia
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
3.3%
2/61 • Number of events 2
|
|
Ear and labyrinth disorders
Deafness
|
1.6%
1/61 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.3%
2/61 • Number of events 2
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.6%
1/61 • Number of events 1
|
|
Ear and labyrinth disorders
Ototoxicity
|
11.5%
7/61 • Number of events 14
|
|
Ear and labyrinth disorders
Tinnitus
|
6.6%
4/61 • Number of events 4
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Blepharitis
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Cataract
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Dry eye
|
4.9%
3/61 • Number of events 3
|
|
Eye disorders
Growth of eyelashes
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
3/61 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
8/61 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
5/61 • Number of events 5
|
|
Gastrointestinal disorders
Cheilitis
|
1.6%
1/61 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
32.8%
20/61 • Number of events 25
|
|
Gastrointestinal disorders
Diarrhoea
|
29.5%
18/61 • Number of events 29
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
3/61 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
11.5%
7/61 • Number of events 7
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Lip dry
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
73.8%
45/61 • Number of events 79
|
|
Gastrointestinal disorders
Odynophagia
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal pain
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
34.4%
21/61 • Number of events 44
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
22/61 • Number of events 39
|
|
General disorders
Asthenia
|
41.0%
25/61 • Number of events 83
|
|
General disorders
Axillary pain
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Chest pain
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Chills
|
4.9%
3/61 • Number of events 3
|
|
General disorders
Face oedema
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Fatigue
|
36.1%
22/61 • Number of events 39
|
|
General disorders
Feeling cold
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Gait disturbance
|
4.9%
3/61 • Number of events 3
|
|
General disorders
General physical health deterioration
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Influenza like illness
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Infusion site extravasation
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Infusion site pain
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Infusion site urticaria
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Malaise
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Mucosal dryness
|
3.3%
2/61 • Number of events 4
|
|
General disorders
Mucosal inflammation
|
11.5%
7/61 • Number of events 9
|
|
General disorders
Non-cardiac chest pain
|
6.6%
4/61 • Number of events 8
|
|
General disorders
Oedema
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Oedema peripheral
|
9.8%
6/61 • Number of events 7
|
|
General disorders
Pain
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Pyrexia
|
19.7%
12/61 • Number of events 17
|
|
Immune system disorders
Hypersensitivity
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Adenoviral conjunctivitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Candida infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Clostridium difficile infection
|
1.6%
1/61 • Number of events 2
|
|
Infections and infestations
Conjunctivitis
|
9.8%
6/61 • Number of events 11
|
|
Infections and infestations
Dermatophytosis of nail
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Device related infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
4.9%
3/61 • Number of events 3
|
|
Infections and infestations
Genital infection fungal
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Herpes virus infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Impetigo
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • Number of events 2
|
|
Infections and infestations
Nail infection
|
3.3%
2/61 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Oral candidiasis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Paronychia
|
19.7%
12/61 • Number of events 40
|
|
Infections and infestations
Pharyngitis
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
4.9%
3/61 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Scrotal infection
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Skin infection
|
3.3%
2/61 • Number of events 3
|
|
Infections and infestations
Soft tissue infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
9.8%
6/61 • Number of events 6
|
|
Infections and infestations
Viral infection
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Wound infection
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/61 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fracture
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Blood urea increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Fibrin d dimer increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Glomerular filtration rate increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Lymphocyte count increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
8.2%
5/61 • Number of events 11
|
|
Investigations
Platelet count decreased
|
8.2%
5/61 • Number of events 11
|
|
Investigations
Platelet count increased
|
4.9%
3/61 • Number of events 3
|
|
Investigations
Respiratory rate increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Troponin i increased
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Weight decreased
|
29.5%
18/61 • Number of events 24
|
|
Investigations
Weight increased
|
8.2%
5/61 • Number of events 5
|
|
Investigations
White blood cell count decreased
|
4.9%
3/61 • Number of events 3
|
|
Metabolism and nutrition disorders
Cachexia
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
57.4%
35/61 • Number of events 52
|
|
Metabolism and nutrition disorders
Dehydration
|
8.2%
5/61 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
2/61 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.9%
3/61 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.6%
1/61 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.3%
2/61 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
2/61 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.1%
8/61 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
32.8%
20/61 • Number of events 45
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/61 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
5/61 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
4/61 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.9%
3/61 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.2%
5/61 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.9%
3/61 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.9%
3/61 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
7/61 • Number of events 7
|
|
Nervous system disorders
Aphasia
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Aphonia
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
23.0%
14/61 • Number of events 17
|
|
Nervous system disorders
Dysaesthesia
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
13.1%
8/61 • Number of events 8
|
|
Nervous system disorders
Headache
|
16.4%
10/61 • Number of events 12
|
|
Nervous system disorders
Ischaemic stroke
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
3.3%
2/61 • Number of events 2
|
|
Nervous system disorders
Neuralgia
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
6.6%
4/61 • Number of events 10
|
|
Nervous system disorders
Neurotoxicity
|
6.6%
4/61 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
8.2%
5/61 • Number of events 8
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.9%
3/61 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Syncope
|
4.9%
3/61 • Number of events 3
|
|
Nervous system disorders
Tremor
|
1.6%
1/61 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.6%
4/61 • Number of events 4
|
|
Psychiatric disorders
Confusional state
|
3.3%
2/61 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
1.6%
1/61 • Number of events 1
|
|
Psychiatric disorders
Depression
|
3.3%
2/61 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
19.7%
12/61 • Number of events 14
|
|
Psychiatric disorders
Irritability
|
1.6%
1/61 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
2/61 • Number of events 2
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.6%
1/61 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
4.9%
3/61 • Number of events 3
|
|
Renal and urinary disorders
Haematuria
|
3.3%
2/61 • Number of events 2
|
|
Renal and urinary disorders
Micturition frequency decreased
|
1.6%
1/61 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
4.9%
3/61 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/61 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
2/61 • Number of events 2
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.0%
1/49 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular pain
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
4.9%
3/61 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.9%
17/61 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
2/61 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.2%
16/61 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.5%
7/61 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.8%
6/61 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.2%
5/61 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.6%
1/61 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.8%
9/61 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.9%
3/61 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
3/61 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
2/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.8%
9/61 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
19.7%
12/61 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.7%
12/61 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
3.3%
2/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.6%
1/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
5/61 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
45.9%
28/61 • Number of events 109
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.6%
4/61 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scab
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
13.1%
8/61 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.6%
1/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
1/61 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Aortic thrombosis
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Embolism
|
3.3%
2/61 • Number of events 2
|
|
Vascular disorders
Haematoma
|
1.6%
1/61 • 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