Trial Outcomes & Findings for Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer (NCT NCT00363415)
NCT ID: NCT00363415
Last Updated: 2009-10-28
Results Overview
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
908 participants
Primary outcome timeframe
baseline to date of death from any cause (up to 19.6 months)
Results posted on
2009-10-28
Participant Flow
Participants who received at least one dose of study drug were, per protocol, the patient population used for the summary of safety data (eg, Serious Adverse Events).
Participant milestones
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
455
|
|
Overall Study
Received at Least One Dose of Study Drug
|
433
|
447
|
|
Overall Study
COMPLETED
|
92
|
206
|
|
Overall Study
NOT COMPLETED
|
361
|
249
|
Reasons for withdrawal
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Overall Study
Progressive Disease
|
196
|
107
|
|
Overall Study
Sponsor Decision
|
67
|
31
|
|
Overall Study
Death
|
32
|
29
|
|
Overall Study
Adverse Event
|
24
|
15
|
|
Overall Study
Physician Decision
|
18
|
35
|
|
Overall Study
Entry Criteria Not Met
|
11
|
10
|
|
Overall Study
Withdrawal by Subject
|
9
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Protocol Violation
|
1
|
4
|
Baseline Characteristics
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Carboplatin
n=453 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=455 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Total
n=908 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=65 years
|
267 participants
n=93 Participants
|
275 participants
n=4 Participants
|
542 participants
n=27 Participants
|
|
Age, Customized
>65 years
|
186 participants
n=93 Participants
|
180 participants
n=4 Participants
|
366 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
253 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=93 Participants
|
330 Participants
n=4 Participants
|
655 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=93 Participants
|
83 participants
n=4 Participants
|
175 participants
n=27 Participants
|
|
Region of Enrollment
Portugal
|
9 participants
n=93 Participants
|
7 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
11 participants
n=93 Participants
|
12 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=93 Participants
|
21 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Region of Enrollment
Russian Federation
|
30 participants
n=93 Participants
|
16 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
India
|
12 participants
n=93 Participants
|
14 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Region of Enrollment
France
|
19 participants
n=93 Participants
|
10 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
17 participants
n=93 Participants
|
17 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Region of Enrollment
China
|
14 participants
n=93 Participants
|
18 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
17 participants
n=93 Participants
|
15 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
15 participants
n=93 Participants
|
13 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=93 Participants
|
14 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=93 Participants
|
18 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=93 Participants
|
13 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=93 Participants
|
6 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=93 Participants
|
17 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=93 Participants
|
7 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
29 participants
n=93 Participants
|
34 participants
n=4 Participants
|
63 participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
20 participants
n=93 Participants
|
23 participants
n=4 Participants
|
43 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
58 participants
n=93 Participants
|
59 participants
n=4 Participants
|
117 participants
n=27 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0 - Fully Active
|
133 participants
n=93 Participants
|
121 participants
n=4 Participants
|
254 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
265 participants
n=93 Participants
|
277 participants
n=4 Participants
|
542 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2 - Ambulatory, No Work Activities
|
54 participants
n=93 Participants
|
55 participants
n=4 Participants
|
109 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
3 - Partially Confined to Bed, Limited Self Care
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Not Reported
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
History of Brain Metastases
No
|
410 participants
n=93 Participants
|
412 participants
n=4 Participants
|
822 participants
n=27 Participants
|
|
History of Brain Metastases
Yes
|
43 participants
n=93 Participants
|
41 participants
n=4 Participants
|
84 participants
n=27 Participants
|
|
History of Brain Metastases
Not Reported
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity
Caucasian
|
391 participants
n=93 Participants
|
379 participants
n=4 Participants
|
770 participants
n=27 Participants
|
|
Race/Ethnicity
East Asian
|
43 participants
n=93 Participants
|
49 participants
n=4 Participants
|
92 participants
n=27 Participants
|
|
Race/Ethnicity
West Asian
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Race/Ethnicity
African
|
5 participants
n=93 Participants
|
8 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Race/Ethnicity
Hispanic
|
1 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Race/Ethnicity
Aboriginal and/or Torres Strait Islander
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity
Native American
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline to date of death from any cause (up to 19.6 months)Population: Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=211 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=167 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Overall Survival
|
8.1 months
Interval 7.3 to 9.1
|
10.6 months
Interval 9.7 to 11.6
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (up to 19.6 months)Population: Number of randomized participants.
The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH\<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=453 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=455 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Overall Survival (Subgroups)
Region: United States (n=92, n=83)
|
8.1 months
Interval 7.3 to 9.8
|
11.3 months
Interval 9.3 to 12.9
|
|
Overall Survival (Subgroups)
Sex: Male (n=325, n=330)
|
8.2 months
Interval 7.2 to 9.1
|
10.4 months
Interval 9.3 to 11.5
|
|
Overall Survival (Subgroups)
Sex: Female (n=128, n=125)
|
8.1 months
Interval 7.2 to 9.7
|
11.6 months
Interval 10.3 to 13.0
|
|
Overall Survival (Subgroups)
Race: Caucasian (n=391, n=379)
|
8.2 months
Interval 7.6 to 9.4
|
11.2 months
Interval 9.9 to 12.0
|
|
Overall Survival (Subgroups)
Race: Non-Caucasian (n=62, n=76)
|
7.1 months
Interval 5.7 to 9.1
|
8.7 months
Interval 7.2 to 14.9
|
|
Overall Survival (Subgroups)
ECOG: 0 or 1 (n=398, n=398)
|
8.5 months
Interval 7.8 to 9.4
|
11.3 months
Interval 10.1 to 12.0
|
|
Overall Survival (Subgroups)
ECOG: 2 (n=54, n=55)
|
6.2 months
Interval 3.7 to 7.3
|
5.2 months
Interval 3.9 to 9.5
|
|
Overall Survival (Subgroups)
Region: European Union (n=279, n=278)
|
8.5 months
Interval 7.2 to 9.7
|
11.2 months
Interval 9.5 to 12.9
|
|
Overall Survival (Subgroups)
Region: Intercontinential Region (n=82, n=94)
|
7.2 months
Interval 6.1 to 8.6
|
9.9 months
Interval 8.5 to 11.9
|
|
Overall Survival (Subgroups)
LDH: >Upper Limit of Normal (n=276, n=273)
|
7.2 months
Interval 6.5 to 8.3
|
9.3 months
Interval 8.0 to 10.4
|
|
Overall Survival (Subgroups)
Age: <= 65 years (n=267, n=275)
|
8.4 months
Interval 7.5 to 9.7
|
11.5 months
Interval 10.3 to 12.9
|
|
Overall Survival (Subgroups)
Age: >65 years (n=186, n=180)
|
7.7 months
Interval 7.1 to 9.0
|
9.7 months
Interval 8.7 to 11.3
|
|
Overall Survival (Subgroups)
Number Metastatic Sites: <=2 (n=172, n=204)
|
10.0 months
Interval 8.6 to 13.5
|
11.5 months
Interval 10.1 to 13.2
|
|
Overall Survival (Subgroups)
Number Metastatic Sites: >=3 (n=273, n=246)
|
7.7 months
Interval 7.2 to 8.2
|
10.3 months
Interval 9.3 to 11.3
|
|
Overall Survival (Subgroups)
History of Brain Metastases: No (n=410, n=412)
|
8.2 months
Interval 7.3 to 9.1
|
10.6 months
Interval 9.5 to 11.6
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 14.7 months)Population: All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.
The period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=453 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=455 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Progression Free Survival
|
3.8 months
Interval 3.5 to 4.2
|
5.4 months
Interval 5.2 to 5.7
|
SECONDARY outcome
Timeframe: baseline and 6 cycles (21-day cycles)Population: Number of randomized participants with baseline and non-missing value at respective cycle.
FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=384 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=383 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Baseline (n=384, n=383)
|
87.42 units on a scale
Standard Deviation 15.40
|
87.79 units on a scale
Standard Deviation 16.63
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 1 Change from Baseline (n=270, n=275)
|
-0.22 units on a scale
Standard Deviation 12.48
|
1.55 units on a scale
Standard Deviation 11.11
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 2 Change from Baseline (n=283, n=310)
|
0.17 units on a scale
Standard Deviation 13.72
|
1.73 units on a scale
Standard Deviation 12.73
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 3 Change from Baseline (n=225, n=277)
|
0.06 units on a scale
Standard Deviation 14.61
|
1.70 units on a scale
Standard Deviation 13.98
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 4 Change from Baseline (n=199, n=259)
|
-0.14 units on a scale
Standard Deviation 15.28
|
1.69 units on a scale
Standard Deviation 13.42
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 5 Change from Baseline (n=140, n=203)
|
0.27 units on a scale
Standard Deviation 16.34
|
1.94 units on a scale
Standard Deviation 14.06
|
|
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Cycle 6 Change from Baseline (n=98, n=146)
|
0.34 units on a scale
Standard Deviation 17.56
|
3.73 units on a scale
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: baseline to date of death due to any cause (up to 19.6 months)Population: The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.
The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: baseline to date of death due to any cause (up to 19.6 months)Population: Number of randomized participants.
Number of participants with Low Density Lipoprotein \<=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH\<=Upper Limit of Normal and History of Brain Metastases=Yes).
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=453 Participants
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
Etoposide + Carboplatin
n=455 Participants
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
|
|---|---|---|
|
Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes
LDH: <=Upper Limit of Normal
|
167 participants
|
169 participants
|
|
Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes
History of Brain Metastases: Yes
|
43 participants
|
41 participants
|
Adverse Events
Pemetrexed + Carboplatin
Serious events: 150 serious events
Other events: 425 other events
Deaths: 0 deaths
Etoposide + Carboplatin
Serious events: 134 serious events
Other events: 438 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
|
Etoposide + Carboplatin
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
(Participants who received at least one dose of study drug)
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
18/433 • Number of events 20
|
1.6%
7/447 • Number of events 7
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
7/433 • Number of events 8
|
3.1%
14/447 • Number of events 14
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.92%
4/433 • Number of events 4
|
0.89%
4/447 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
11/433 • Number of events 12
|
4.3%
19/447 • Number of events 21
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
15/433 • Number of events 18
|
1.6%
7/447 • Number of events 8
|
|
Cardiac disorders
Acute coronary syndrome
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Acute left ventricular failure
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
5/433 • Number of events 5
|
0.00%
0/447
|
|
Cardiac disorders
Atrial flutter
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
2/433 • Number of events 2
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Cardiac fibrillation
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.46%
2/433 • Number of events 2
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
4/433 • Number of events 4
|
0.22%
1/447 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.23%
1/433 • Number of events 1
|
0.45%
2/447 • Number of events 2
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
4/433 • Number of events 4
|
0.22%
1/447 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.46%
2/433 • Number of events 2
|
0.45%
2/447 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Gastrointestinal disorders
Constipation
|
0.92%
4/433 • Number of events 4
|
0.89%
4/447 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
11/433 • Number of events 11
|
0.67%
3/447 • Number of events 3
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.69%
3/433 • Number of events 3
|
0.22%
1/447 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Nausea
|
3.5%
15/433 • Number of events 18
|
0.45%
2/447 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Gastrointestinal disorders
Oral discomfort
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Gastrointestinal disorders
Proctitis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
11/433 • Number of events 11
|
0.89%
4/447 • Number of events 4
|
|
General disorders
Asthenia
|
0.92%
4/433 • Number of events 4
|
0.45%
2/447 • Number of events 2
|
|
General disorders
Chest discomfort
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
General disorders
Chest pain
|
0.92%
4/433 • Number of events 4
|
0.89%
4/447 • Number of events 4
|
|
General disorders
Condition aggravated
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
General disorders
Fatigue
|
0.69%
3/433 • Number of events 3
|
0.45%
2/447 • Number of events 2
|
|
General disorders
General physical health deterioration
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
General disorders
Malaise
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
General disorders
Mucosal inflammation
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
General disorders
Pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
General disorders
Performance status decreased
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
General disorders
Pyrexia
|
0.69%
3/433 • Number of events 3
|
1.1%
5/447 • Number of events 6
|
|
General disorders
Sudden death
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
General disorders
Visceral oedema
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Immune system disorders
Anaphylactic shock
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Cellulitis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Empyema
|
0.69%
3/433 • Number of events 3
|
0.45%
2/447 • Number of events 3
|
|
Infections and infestations
Encephalitis herpes
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Enteritis infectious
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Febrile infection
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Infection
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Klebsiella sepsis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Lower respiratory tract infection
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Infections and infestations
Lung abscess
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Infections and infestations
Necrotising fasciitis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Neutropenic sepsis
|
0.23%
1/433 • Number of events 1
|
0.45%
2/447 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
4.6%
20/433 • Number of events 24
|
3.4%
15/447 • Number of events 16
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Pneumonia primary atypical
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/433 • Number of events 1
|
0.67%
3/447 • Number of events 3
|
|
Infections and infestations
Sepsis
|
1.2%
5/433 • Number of events 5
|
1.1%
5/447 • Number of events 5
|
|
Infections and infestations
Septic shock
|
0.69%
3/433 • Number of events 3
|
0.00%
0/447
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.69%
3/433 • Number of events 3
|
0.67%
3/447 • Number of events 3
|
|
Infections and infestations
Wound infection
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.23%
1/433 • Number of events 2
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Overdose
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Investigations
Blood bilirubin increased
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Investigations
Blood creatinine increased
|
0.46%
2/433 • Number of events 2
|
0.22%
1/447 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Investigations
C-reactive protein increased
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
6/433 • Number of events 6
|
0.89%
4/447 • Number of events 5
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.46%
2/433 • Number of events 2
|
0.00%
0/447
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
6/433 • Number of events 6
|
1.1%
5/447 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.69%
3/433 • Number of events 3
|
0.22%
1/447 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Ataxia
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Carotid artery occlusion
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Convulsion
|
0.46%
2/433 • Number of events 2
|
1.3%
6/447 • Number of events 6
|
|
Nervous system disorders
Diplegia
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Epilepsy
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Nervous system disorder
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Nervous system disorders
Spinal cord compression
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/433 • Number of events 1
|
0.45%
2/447 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Psychiatric disorders
Tobacco withdrawal symptoms
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.2%
5/433 • Number of events 5
|
0.22%
1/447 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.46%
2/433 • Number of events 2
|
0.22%
1/447 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/433
|
0.45%
2/447 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
15/433 • Number of events 16
|
3.4%
15/447 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.69%
3/433 • Number of events 3
|
0.67%
3/447 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
1/433 • Number of events 1
|
0.67%
3/447 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
2/433 • Number of events 2
|
0.67%
3/447 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/433
|
0.45%
2/447 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.23%
1/433 • Number of events 1
|
0.22%
1/447 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
4/433 • Number of events 4
|
0.00%
0/447
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/433
|
0.22%
1/447 • Number of events 1
|
|
Vascular disorders
Superior vena caval occlusion
|
0.92%
4/433 • Number of events 4
|
0.45%
2/447 • Number of events 2
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Vascular disorders
Thrombosis
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
|
Vascular disorders
Vascular insufficiency
|
0.23%
1/433 • Number of events 1
|
0.00%
0/447
|
Other adverse events
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
|
Etoposide + Carboplatin
Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
(Participants who received at least one dose of study drug)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
135/433 • Number of events 175
|
34.7%
155/447 • Number of events 200
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.6%
33/433 • Number of events 67
|
19.2%
86/447 • Number of events 179
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.9%
82/433 • Number of events 141
|
56.4%
252/447 • Number of events 524
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.1%
61/433 • Number of events 117
|
21.0%
94/447 • Number of events 151
|
|
Cardiac disorders
Coronary artery disease
|
5.3%
23/433 • Number of events 23
|
5.4%
24/447 • Number of events 24
|
|
Endocrine disorders
Hypothyroidism
|
6.0%
26/433 • Number of events 26
|
2.7%
12/447 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
24/433 • Number of events 26
|
6.0%
27/447 • Number of events 27
|
|
Gastrointestinal disorders
Constipation
|
31.2%
135/433 • Number of events 165
|
27.7%
124/447 • Number of events 155
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
62/433 • Number of events 72
|
13.2%
59/447 • Number of events 69
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
24/433 • Number of events 24
|
5.4%
24/447 • Number of events 26
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
28/433 • Number of events 28
|
4.7%
21/447 • Number of events 21
|
|
Gastrointestinal disorders
Nausea
|
38.3%
166/433 • Number of events 261
|
35.6%
159/447 • Number of events 267
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
22/433 • Number of events 23
|
3.4%
15/447 • Number of events 19
|
|
Gastrointestinal disorders
Vomiting
|
16.4%
71/433 • Number of events 96
|
16.1%
72/447 • Number of events 106
|
|
General disorders
Asthenia
|
11.1%
48/433 • Number of events 55
|
9.6%
43/447 • Number of events 51
|
|
General disorders
Chest pain
|
22.6%
98/433 • Number of events 104
|
25.5%
114/447 • Number of events 127
|
|
General disorders
Fatigue
|
35.3%
153/433 • Number of events 177
|
40.7%
182/447 • Number of events 221
|
|
General disorders
Mucosal inflammation
|
5.1%
22/433 • Number of events 26
|
5.8%
26/447 • Number of events 33
|
|
General disorders
Oedema peripheral
|
8.8%
38/433 • Number of events 40
|
7.4%
33/447 • Number of events 41
|
|
General disorders
Pyrexia
|
6.0%
26/433 • Number of events 29
|
11.0%
49/447 • Number of events 59
|
|
Investigations
Haemoglobin decreased
|
5.1%
22/433 • Number of events 24
|
3.4%
15/447 • Number of events 15
|
|
Investigations
Weight decreased
|
13.9%
60/433 • Number of events 64
|
11.2%
50/447 • Number of events 53
|
|
Metabolism and nutrition disorders
Anorexia
|
24.9%
108/433 • Number of events 130
|
21.9%
98/447 • Number of events 120
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.4%
45/433 • Number of events 45
|
9.8%
44/447 • Number of events 44
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
10.4%
45/433 • Number of events 45
|
10.5%
47/447 • Number of events 47
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
23/433 • Number of events 25
|
4.0%
18/447 • Number of events 26
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
23/433 • Number of events 24
|
3.8%
17/447 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.8%
25/433 • Number of events 31
|
6.0%
27/447 • Number of events 37
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
23/433 • Number of events 24
|
8.5%
38/447 • Number of events 43
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.1%
61/433 • Number of events 67
|
18.1%
81/447 • Number of events 91
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.5%
15/433 • Number of events 16
|
5.8%
26/447 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
23/433 • Number of events 23
|
6.9%
31/447 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
29/433 • Number of events 30
|
3.8%
17/447 • Number of events 18
|
|
Nervous system disorders
Dizziness
|
6.9%
30/433 • Number of events 34
|
9.2%
41/447 • Number of events 43
|
|
Nervous system disorders
Headache
|
11.3%
49/433 • Number of events 62
|
13.6%
61/447 • Number of events 78
|
|
Psychiatric disorders
Anxiety
|
10.4%
45/433 • Number of events 45
|
8.1%
36/447 • Number of events 36
|
|
Psychiatric disorders
Depression
|
9.5%
41/433 • Number of events 41
|
8.5%
38/447 • Number of events 38
|
|
Psychiatric disorders
Insomnia
|
16.6%
72/433 • Number of events 78
|
15.2%
68/447 • Number of events 78
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
15.9%
69/433 • Number of events 69
|
15.9%
71/447 • Number of events 71
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.5%
210/433 • Number of events 218
|
49.4%
221/447 • Number of events 239
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.3%
49/433 • Number of events 50
|
9.4%
42/447 • Number of events 43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
41.1%
178/433 • Number of events 189
|
40.7%
182/447 • Number of events 200
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.6%
33/433 • Number of events 34
|
7.2%
32/447 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.2%
31/433 • Number of events 31
|
4.5%
20/447 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
27/433 • Number of events 29
|
34.9%
156/447 • Number of events 158
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
23/433 • Number of events 24
|
5.6%
25/447 • Number of events 36
|
|
Vascular disorders
Hypertension
|
41.6%
180/433 • Number of events 181
|
38.5%
172/447 • Number of events 175
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60