Trial Outcomes & Findings for A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NCT NCT01769391)
NCT ID: NCT01769391
Last Updated: 2019-09-20
Results Overview
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline to Disease Progression or Death (Up to 24 Months)
Results posted on
2019-09-20
Participant Flow
A completer is defined as having a complete radiographic assessment at baseline and at least one complete post-baseline radiographic assessment of CR, PR , SD or PD.
Participant milestones
| Measure |
Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
57
|
|
Overall Study
Received at Least One Dose of Study Drug
|
106
|
55
|
|
Overall Study
COMPLETED
|
93
|
48
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Overall Study
Death
|
10
|
1
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Progressive Disease
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Investigator Decision
|
2
|
0
|
Baseline Characteristics
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=110 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m\^2) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=57 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 8.27 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Disease Progression or Death (Up to 24 Months)Population: All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=94 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=50 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
|
48.9 percentage of participants
Interval 38.5 to 59.5
|
40.0 percentage of participants
Interval 26.4 to 54.8
|
SECONDARY outcome
Timeframe: Randomization to Date of Death (Up to 24 Months)Population: All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.
OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=110 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=57 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Overall Survival (OS)
|
13.2 months
Interval 9.7 to 15.9
|
11.2 months
Interval 8.2 to 12.7
|
SECONDARY outcome
Timeframe: Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)Population: All participants who received at least one dose of necitumumab and had evaluable PK data.
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=92 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
Cycle 1, Day 1 (n=92)
|
262.418 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 32.84
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
Cycle 3, Day 1 (n=72)
|
296.843 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 62.97
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
Cycle 5, Day 1 (n=62)
|
303.475 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 53.75
|
—
|
SECONDARY outcome
Timeframe: Baseline to End of Cycle 6Population: All participants who received any amount of necitumumab and had post baseline antibody data.
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=106 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Percentage of Participants With Anti Necitumumab Antibodies
|
2.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease or Death (Up to 24 Months)Population: All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.
Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is 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 |
Necitumumab +Paclitaxel+Carboplatin
n=110 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=57 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Progression-Free Survival
|
5.4 months
Interval 4.2 to 5.7
|
5.6 months
Interval 4.3 to 6.8
|
SECONDARY outcome
Timeframe: Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)Population: All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.
Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=94 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=50 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
|
87.2 percentage of participants
Interval 78.8 to 93.2
|
84.0 percentage of participants
Interval 70.9 to 92.8
|
SECONDARY outcome
Timeframe: Baseline to Progressive Disease or Death (Up to 24 Months)Population: All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.
CTS is defined as maximum percent change from baseline in the sum of target lesions.
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=83 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
n=43 Participants
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Percent Change in Tumor Size (CTS)
|
-44.3 percent change in tumor size
Standard Deviation 22.8
|
-38.65 percent change in tumor size
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=92 Participants
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
|
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 1, Day 8 (n-85)
|
59.269 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 59.06
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 2, Day 1 (n=79)
|
47.874 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 79.89
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 3, Day 1 (n=76)
|
78.142 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 70.99
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 4, Day 1 (n=70)
|
80.392 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 74.42
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 5, Day 1 (n=62)
|
89.137 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 88.94
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 6, Day 1 (n=59)
|
87.043 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 85.02
|
—
|
Adverse Events
Necitumumab +Paclitaxel+Carboplatin
Serious events: 43 serious events
Other events: 102 other events
Deaths: 0 deaths
Paclitaxel + Carboplatin
Serious events: 21 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=106 participants at risk
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles.
|
Paclitaxel + Carboplatin
n=55 participants at risk
Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
5/106 • Number of events 5
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.6%
7/106 • Number of events 7
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
5/106 • Number of events 5
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
2/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
4/106 • Number of events 4
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.94%
1/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
4.7%
5/106 • Number of events 10
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
General disorders
Brain death
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
13.2%
14/106 • Number of events 15
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.8%
3/106 • Number of events 4
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
3/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
5/106 • Number of events 5
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Circulatory collapse
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haemorrhage
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypovolaemic shock
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Necitumumab +Paclitaxel+Carboplatin
n=106 participants at risk
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles.
|
Paclitaxel + Carboplatin
n=55 participants at risk
Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.1%
34/106 • Number of events 87
All participants who received at least 1 dose of study drug.
|
49.1%
27/55 • Number of events 62
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.5%
9/106 • Number of events 16
All participants who received at least 1 dose of study drug.
|
16.4%
9/55 • Number of events 15
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.9%
37/106 • Number of events 73
All participants who received at least 1 dose of study drug.
|
29.1%
16/55 • Number of events 43
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.5%
27/106 • Number of events 67
All participants who received at least 1 dose of study drug.
|
25.5%
14/55 • Number of events 31
All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
8/106 • Number of events 11
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
23.6%
25/106 • Number of events 28
All participants who received at least 1 dose of study drug.
|
27.3%
15/55 • Number of events 23
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.5%
26/106 • Number of events 34
All participants who received at least 1 dose of study drug.
|
21.8%
12/55 • Number of events 18
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
6/106 • Number of events 6
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
27/106 • Number of events 35
All participants who received at least 1 dose of study drug.
|
36.4%
20/55 • Number of events 34
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
13.2%
14/106 • Number of events 15
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
13/106 • Number of events 17
All participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
17.0%
18/106 • Number of events 31
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
31.1%
33/106 • Number of events 52
All participants who received at least 1 dose of study drug.
|
43.6%
24/55 • Number of events 48
All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.6%
7/106 • Number of events 8
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.4%
11/106 • Number of events 15
All participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
6.6%
7/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
9.4%
10/106 • Number of events 16
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
6.6%
7/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
5.7%
6/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.7%
6/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
7/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
7.5%
8/106 • Number of events 18
All participants who received at least 1 dose of study drug.
|
10.9%
6/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
29.2%
31/106 • Number of events 49
All participants who received at least 1 dose of study drug.
|
25.5%
14/55 • Number of events 20
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.1%
34/106 • Number of events 40
All participants who received at least 1 dose of study drug.
|
27.3%
15/55 • Number of events 20
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
11/106 • Number of events 15
All participants who received at least 1 dose of study drug.
|
18.2%
10/55 • Number of events 17
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.7%
5/106 • Number of events 9
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.4%
10/106 • Number of events 19
All participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.2%
14/106 • Number of events 28
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
23.6%
25/106 • Number of events 74
All participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Number of events 12
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
7/106 • Number of events 13
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.6%
24/106 • Number of events 61
All participants who received at least 1 dose of study drug.
|
23.6%
13/55 • Number of events 29
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
10/106 • Number of events 11
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
8/106 • Number of events 10
All participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Number of events 14
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.4%
10/106 • Number of events 10
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.8%
3/106 • Number of events 5
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.0%
18/106 • Number of events 44
All participants who received at least 1 dose of study drug.
|
21.8%
12/55 • Number of events 21
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
8/106 • Number of events 10
All participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
13.2%
14/106 • Number of events 16
All participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Number of events 10
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
7.5%
8/106 • Number of events 10
All participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.8%
4/106 • Number of events 6
All participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.3%
13/106 • Number of events 21
All participants who received at least 1 dose of study drug.
|
16.4%
9/55 • Number of events 18
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
2.8%
3/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.2%
31/106 • Number of events 54
All participants who received at least 1 dose of study drug.
|
23.6%
13/55 • Number of events 24
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
7.5%
8/106 • Number of events 8
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.7%
6/106 • Number of events 6
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
13.2%
14/106 • Number of events 16
All participants who received at least 1 dose of study drug.
|
10.9%
6/55 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
18/106 • Number of events 24
All participants who received at least 1 dose of study drug.
|
18.2%
10/55 • Number of events 10
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.8%
4/106 • Number of events 5
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.7%
23/106 • Number of events 29
All participants who received at least 1 dose of study drug.
|
10.9%
6/55 • Number of events 13
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.6%
7/106 • Number of events 7
All participants who received at least 1 dose of study drug.
|
10.9%
6/55 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
4/106 • Number of events 6
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
3/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.4%
28/106 • Number of events 30
All participants who received at least 1 dose of study drug.
|
18.2%
10/55 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
21.7%
23/106 • Number of events 40
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.3%
13/106 • Number of events 13
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
6/106 • Number of events 6
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.8%
22/106 • Number of events 69
All participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.5%
8/106 • Number of events 17
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
11.3%
12/106 • Number of events 16
All participants who received at least 1 dose of study drug.
|
0.00%
0/55
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
11.3%
12/106 • Number of events 13
All participants who received at least 1 dose of study drug.
|
12.7%
7/55 • Number of events 10
All participants who received at least 1 dose of study drug.
|
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