Trial Outcomes & Findings for First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (NCT NCT00982111)
NCT ID: NCT00982111
Last Updated: 2022-01-11
Results Overview
OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
633 participants
Primary outcome timeframe
Randomization to Death from Any Cause (Up to 31.6 Months)
Results posted on
2022-01-11
Participant Flow
Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
Participant milestones
| Measure |
Necitumumab + Pemetrexed + Cisplatin
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.
Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
|
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
315
|
318
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
304
|
312
|
|
Overall Study
Death Due to Any Cause
|
236
|
246
|
|
Overall Study
COMPLETED
|
236
|
246
|
|
Overall Study
NOT COMPLETED
|
79
|
72
|
Reasons for withdrawal
| Measure |
Necitumumab + Pemetrexed + Cisplatin
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.
Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
|
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Progressive Disease
|
46
|
39
|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
|
Overall Study
New Anti-Cancer Therapy
|
5
|
5
|
|
Overall Study
Medical Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
17
|
19
|
|
Overall Study
Global Study End
|
0
|
1
|
|
Overall Study
Sponsor's Decision
|
0
|
1
|
Baseline Characteristics
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Baseline characteristics by cohort
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Total
n=633 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
61.0 years
n=5 Participants
|
60.0 years
n=7 Participants
|
61.00 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
268 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
540 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
292 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
590 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 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
Russian Federation
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
21 participants
n=5 Participants
|
31 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
40 participants
n=5 Participants
|
27 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
75 participants
n=5 Participants
|
84 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
0
|
115 participants
n=5 Participants
|
132 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
1
|
183 participants
n=5 Participants
|
166 participants
n=7 Participants
|
349 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
2
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Smoking
Ex-Light Smoker
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Smoking
Nonsmoker
|
51 participants
n=5 Participants
|
53 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Smoking
Smoker
|
238 participants
n=5 Participants
|
238 participants
n=7 Participants
|
476 participants
n=5 Participants
|
|
Disease Stage at Study Entry
Stage IIIB
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Disease Stage at Study Entry
Stage IV
|
305 participants
n=5 Participants
|
307 participants
n=7 Participants
|
612 participants
n=5 Participants
|
|
Disease Stage at Study Entry
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Histology
Adenocarcinoma/Large Cell Carcinoma
|
307 participants
n=5 Participants
|
311 participants
n=7 Participants
|
618 participants
n=5 Participants
|
|
Disease Histology
Other
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Disease Histology
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Bone
|
103 participants
n=5 Participants
|
109 participants
n=7 Participants
|
212 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Brain
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Liver
|
58 participants
n=5 Participants
|
64 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Lung
|
259 participants
n=5 Participants
|
268 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Lymph Nodes
|
239 participants
n=5 Participants
|
240 participants
n=7 Participants
|
479 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Peritoneal
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Pleural
|
111 participants
n=5 Participants
|
111 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Skin
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Soft Tissue
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Sites of Metastatic Disease
Other
|
87 participants
n=5 Participants
|
93 participants
n=7 Participants
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Death from Any Cause (Up to 31.6 Months)Population: All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72
OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Overall Survival Time (OS)
|
11.3 Months
Interval 9.5 to 13.4
|
11.5 Months
Interval 10.1 to 13.1
|
SECONDARY outcome
Timeframe: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)Population: All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79
PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
5.6 Months
Interval 5.1 to 6.0
|
5.6 Months
Interval 4.8 to 5.7
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 30.4 Months)Population: All randomized participants.
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; 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. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])
|
31.1 percentage of participants
Interval 26.3 to 36.4
|
32.1 percentage of participants
Interval 27.2 to 37.4
|
SECONDARY outcome
Timeframe: Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)Population: All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13
TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
3.5 Months
Interval 3.2 to 3.9
|
4.3 Months
Interval 3.3 to 4.8
|
SECONDARY outcome
Timeframe: Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 WeeksPopulation: Participants who were randomized to necitumumab and had evaluable PK data.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Cycle 2 Day 1
|
57.5 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 84.5
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Cycle 3 Day 1
|
80.8 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 89.3
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Cycle 4 Day 1
|
110 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 82.9
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Cycle 5 Day 1
|
115 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 81.8
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Cycle 6 Day 1
|
119 micrograms/milliliter (ug/ml)
Geometric Coefficient of Variation 68.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to Study Completion (Up to 31.6 Months)Population: All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.
A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. 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 |
Necitumumab + Pemetrexed + Cisplatin
n=301 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
1 Positive Titer
|
37 participants
|
—
|
|
Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
Antibodies Detected
|
18 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 6 (Cycle = 3 weeks)Population: All randomized participants who had evaluable baseline and postbaseline EQ-5D data.
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=143 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=147 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)
|
0.0419 units on a scale
Standard Deviation 0.28230
|
0.0478 units on a scale
Standard Deviation 0.22645
|
SECONDARY outcome
Timeframe: Baseline, Cycle 6 (Cycle =3 Weeks)Population: All randomized participants who had evaluable baseline and postbaseline LCSS data.
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=315 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=318 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Loss of Appetite
|
4.6 millimeter (mm)
Standard Deviation 46.18
|
0.6 millimeter (mm)
Standard Deviation 27.52
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Fatigue
|
4.5 millimeter (mm)
Standard Deviation 31.24
|
1.6 millimeter (mm)
Standard Deviation 28.75
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Cough
|
-9.1 millimeter (mm)
Standard Deviation 31.08
|
-10.3 millimeter (mm)
Standard Deviation 27.88
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Dyspnea
|
-2.8 millimeter (mm)
Standard Deviation 26.32
|
-1.5 millimeter (mm)
Standard Deviation 23.67
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Hemoptysis
|
-1.1 millimeter (mm)
Standard Deviation 11.92
|
-1.1 millimeter (mm)
Standard Deviation 7.81
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Pain
|
-4.2 millimeter (mm)
Standard Deviation 27.22
|
-7.1 millimeter (mm)
Standard Deviation 26.64
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Overall Symptoms
|
-3.1 millimeter (mm)
Standard Deviation 31.22
|
-7.4 millimeter (mm)
Standard Deviation 27.11
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Quality of Life
|
2.5 millimeter (mm)
Standard Deviation 26.01
|
-3.3 millimeter (mm)
Standard Deviation 24.91
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Interference
|
3.2 millimeter (mm)
Standard Deviation 27.15
|
-4.0 millimeter (mm)
Standard Deviation 31.39
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Average Symptom Burden Index (ASBI)
|
-0.9 millimeter (mm)
Standard Deviation 18.35
|
-3.1 millimeter (mm)
Standard Deviation 13.11
|
|
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
LCSS Total Score
|
0.1 millimeter (mm)
Standard Deviation 17.59
|
-4.3 millimeter (mm)
Standard Deviation 13.90
|
SECONDARY outcome
Timeframe: BaselinePopulation: Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.
EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=245 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=245 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
H-score <200
|
69.06 H-Score
Standard Deviation 64.68
|
66.23 H-Score
Standard Deviation 64.15
|
|
Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
H-score >=200
|
259.35 H-Score
Standard Deviation 27.65
|
256.26 H-Score
Standard Deviation 29.10
|
SECONDARY outcome
Timeframe: BaselinePopulation: Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment
EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
Outcome measures
| Measure |
Necitumumab + Pemetrexed + Cisplatin
n=245 Participants
Necitumumab + Pemetrexed + Cisplatin
Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed + Cisplatin
n=245 Participants
Pemetrexed + Cisplatin
Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Percentage of Participants With EGFR Measured by IHC
H-score <200
|
58.8 percentage of participants
|
59.6 percentage of participants
|
|
Percentage of Participants With EGFR Measured by IHC
H-score >=200
|
41.2 percentage of participants
|
40.4 percentage of participants
|
Adverse Events
Necitumumab+Pemetrexed+Cisplatin
Serious events: 158 serious events
Other events: 296 other events
Deaths: 236 deaths
Pemetrexed+Cisplatin
Serious events: 130 serious events
Other events: 303 other events
Deaths: 246 deaths
Serious adverse events
| Measure |
Necitumumab+Pemetrexed+Cisplatin
n=304 participants at risk
Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed+Cisplatin
n=312 participants at risk
Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
12/304 • Number of events 15
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
4.2%
13/312 • Number of events 18
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.6%
8/312 • Number of events 8
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
9/304 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
8/304 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 6
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Atrial flutter
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiac failure
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiac tamponade
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Pericardial effusion
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Sinus tachycardia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Ear and labyrinth disorders
Vertigo
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
10/304 • Number of events 11
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Enterocolitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Nausea
|
2.6%
8/304 • Number of events 12
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.9%
6/312 • Number of events 6
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Oesophagitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Stomatitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.96%
3/312 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Volvulus
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
9/304 • Number of events 10
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.2%
7/312 • Number of events 7
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Asthenia
|
2.6%
8/304 • Number of events 11
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Chest pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Death
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Fatigue
|
2.6%
8/304 • Number of events 10
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.2%
7/312 • Number of events 7
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
General physical health deterioration
|
2.0%
6/304 • Number of events 7
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.3%
4/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Mucosal inflammation
|
1.3%
4/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Multi-organ failure
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Oedema peripheral
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Performance status decreased
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Pyrexia
|
1.3%
4/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Systemic inflammatory response syndrome
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Hepatobiliary disorders
Biliary colic
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Abscess limb
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Bronchitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Device related infection
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Erysipelas
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Gastrointestinal infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Hepatitis b
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Herpes dermatitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Herpes oesophagitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Infection
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Intestinal gangrene
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Lung infection
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Neutropenic sepsis
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Oral candidiasis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Peritoneal infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Pneumonia
|
4.6%
14/304 • Number of events 14
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.9%
6/312 • Number of events 7
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.96%
3/312 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Sepsis
|
1.3%
4/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Septic shock
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Skin bacterial infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Skin infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Staphylococcal infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Staphylococcal sepsis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.66%
2/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Medication error
|
2.0%
6/304 • Number of events 6
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
International normalised ratio increased
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Weight decreased
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
6/304 • Number of events 6
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.96%
3/312 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Cachexia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
4/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 8
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.99%
3/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.33%
1/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
7.9%
24/304 • Number of events 24
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.2%
10/312 • Number of events 10
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Cerebral infarction
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Cerebral ischaemia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.3%
4/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Convulsion
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Dizziness
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Dizziness postural
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Ischaemic stroke
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Migraine
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Paraesthesia
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Syncope
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Agitation
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Depression
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Renal and urinary disorders
Renal failure
|
1.3%
4/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.9%
6/312 • Number of events 7
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Renal and urinary disorders
Renal failure acute
|
0.99%
3/304 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
8/304 • Number of events 8
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 8
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.96%
3/312 • Number of events 3
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
13/304 • Number of events 13
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.5%
11/312 • Number of events 11
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Surgical and medical procedures
Analgesic therapy
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.64%
2/312 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
5/304 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Embolism
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Hypertension
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Orthostatic hypotension
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Peripheral embolism
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Peripheral ischaemia
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Poor venous access
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.66%
2/304 • Number of events 2
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/304
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Thrombosis
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.32%
1/312 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Venous thrombosis limb
|
0.33%
1/304 • Number of events 1
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
Other adverse events
| Measure |
Necitumumab+Pemetrexed+Cisplatin
n=304 participants at risk
Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
Pemetrexed+Cisplatin
n=312 participants at risk
Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
|
|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
30/304 • Number of events 41
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.8%
12/312 • Number of events 22
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Anaemia
|
23.7%
72/304 • Number of events 155
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
29.2%
91/312 • Number of events 200
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.8%
45/304 • Number of events 92
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.5%
36/312 • Number of events 61
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
16/304 • Number of events 53
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.4%
17/312 • Number of events 26
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.3%
92/304 • Number of events 179
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
31.7%
99/312 • Number of events 217
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.2%
22/304 • Number of events 43
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
7.4%
23/312 • Number of events 42
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
15/304 • Number of events 18
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.1%
16/312 • Number of events 18
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Eye disorders
Conjunctivitis
|
10.2%
31/304 • Number of events 46
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.9%
6/312 • Number of events 6
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Eye disorders
Lacrimation increased
|
1.3%
4/304 • Number of events 4
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.4%
17/312 • Number of events 17
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
19/304 • Number of events 25
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
4.8%
15/312 • Number of events 15
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.6%
26/304 • Number of events 36
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.0%
25/312 • Number of events 29
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Constipation
|
29.9%
91/304 • Number of events 133
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
26.6%
83/312 • Number of events 124
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Diarrhoea
|
29.6%
90/304 • Number of events 148
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
16.3%
51/312 • Number of events 78
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
16/304 • Number of events 21
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.8%
18/312 • Number of events 28
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Nausea
|
57.2%
174/304 • Number of events 392
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
58.7%
183/312 • Number of events 403
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Vomiting
|
34.5%
105/304 • Number of events 213
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
33.3%
104/312 • Number of events 180
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Asthenia
|
28.9%
88/304 • Number of events 192
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
21.8%
68/312 • Number of events 146
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Fatigue
|
28.6%
87/304 • Number of events 164
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
30.4%
95/312 • Number of events 171
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Mucosal inflammation
|
16.4%
50/304 • Number of events 104
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.7%
27/312 • Number of events 36
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Non-cardiac chest pain
|
3.6%
11/304 • Number of events 16
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.1%
16/312 • Number of events 22
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Oedema peripheral
|
13.2%
40/304 • Number of events 52
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
13.1%
41/312 • Number of events 51
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Pyrexia
|
15.1%
46/304 • Number of events 57
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
7.1%
22/312 • Number of events 32
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Oral candidiasis
|
5.9%
18/304 • Number of events 22
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Paronychia
|
9.2%
28/304 • Number of events 67
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Urinary tract infection
|
6.2%
19/304 • Number of events 21
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.1%
16/312 • Number of events 21
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Blood creatinine increased
|
6.9%
21/304 • Number of events 34
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.8%
18/312 • Number of events 23
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Weight decreased
|
12.8%
39/304 • Number of events 53
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
7.7%
24/312 • Number of events 28
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Anorexia
|
36.2%
110/304 • Number of events 174
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
31.1%
97/312 • Number of events 171
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.6%
17/304 • Number of events 39
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.8%
12/312 • Number of events 22
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
16/304 • Number of events 34
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.2%
10/312 • Number of events 15
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.9%
30/304 • Number of events 51
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
4.2%
13/312 • Number of events 16
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.6%
20/304 • Number of events 34
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
7.4%
23/312 • Number of events 33
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
24.7%
75/304 • Number of events 185
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.5%
36/312 • Number of events 66
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.6%
23/304 • Number of events 36
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.4%
20/312 • Number of events 30
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
33/304 • Number of events 40
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.4%
20/312 • Number of events 24
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
19/304 • Number of events 26
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
4.8%
15/312 • Number of events 21
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
18/304 • Number of events 22
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.4%
17/312 • Number of events 19
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Dizziness
|
12.5%
38/304 • Number of events 52
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.3%
26/312 • Number of events 37
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Dysgeusia
|
6.9%
21/304 • Number of events 27
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
10.3%
32/312 • Number of events 43
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Headache
|
9.9%
30/304 • Number of events 41
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.7%
27/312 • Number of events 32
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Paraesthesia
|
5.3%
16/304 • Number of events 20
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.6%
8/312 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Depression
|
5.9%
18/304 • Number of events 20
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.2%
10/312 • Number of events 11
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Insomnia
|
5.6%
17/304 • Number of events 23
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
4.8%
15/312 • Number of events 20
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
56/304 • Number of events 75
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
15.4%
48/312 • Number of events 59
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.1%
46/304 • Number of events 62
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
13.1%
41/312 • Number of events 52
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
21/304 • Number of events 30
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
9/312 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.9%
21/304 • Number of events 30
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.2%
10/312 • Number of events 12
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
16/304 • Number of events 17
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.2%
7/312 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
29/304 • Number of events 31
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.8%
18/312 • Number of events 20
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
13.8%
42/304 • Number of events 119
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/312
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.1%
43/304 • Number of events 62
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.5%
11/312 • Number of events 13
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.3%
5/95 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/107
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
31/304 • Number of events 48
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.6%
8/312 • Number of events 9
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.1%
125/304 • Number of events 346
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.4%
20/312 • Number of events 23
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
9.2%
28/304 • Number of events 62
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
1.6%
5/312 • Number of events 5
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Vascular disorders
Hypertension
|
5.6%
17/304 • Number of events 24
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
9.3%
29/312 • Number of events 41
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60