Trial Outcomes & Findings for A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer (NCT NCT01017874)
NCT ID: NCT01017874
Last Updated: 2015-07-08
Results Overview
PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
236 participants
Primary outcome timeframe
Randomization to the first date of measured PD or death up to 37.32 months
Results posted on
2015-07-08
Participant Flow
Participants who died or continued on study but discontinued receiving study drug were considered to be completed.
Participant milestones
| Measure |
Pemetrexed + Cisplatin + Gefitinib
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
118
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
114
|
118
|
|
Overall Study
COMPLETED
|
88
|
92
|
|
Overall Study
NOT COMPLETED
|
30
|
26
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin + Gefitinib
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
20
|
|
Overall Study
Sponsor decision
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
3
|
Baseline Characteristics
A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.53 years
STANDARD_DEVIATION 10.730 • n=5 Participants
|
59.36 years
STANDARD_DEVIATION 10.672 • n=7 Participants
|
58.95 years
STANDARD_DEVIATION 10.686 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
118 participant
n=5 Participants
|
118 participant
n=7 Participants
|
236 participant
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
39 participants
n=5 Participants
|
28 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
54 participants
n=5 Participants
|
60 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to the first date of measured PD or death up to 37.32 monthsPopulation: Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed+Cisplatin+Gefitinib=32, Gefitinib=22.
PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Progression Free Survival (PFS)
|
8.38 months
Interval 6.44 to 11.14
|
9.63 months
Interval 6.74 to 11.1
|
SECONDARY outcome
Timeframe: Randomization up to date of death from any cause up to 57.13 monthsPopulation: ITT population: All data from all randomized participants according to the treatment they were assigned.
OS was the duration from randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date for a particular analysis, OS was censored at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date included adverse event date, lesion assessment date, visit date, and last known alive date).
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Overall Survival (OS)
|
26.87 months
Interval 20.76 to 35.12
|
27.86 months
Interval 21.26 to 31.36
|
SECONDARY outcome
Timeframe: Randomization up to 37.52 monthsPopulation: Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.
TRR was defined as the percentage of randomized participants having a best overall study response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and the appearance of no new lesions.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
|
41.5 percentage of participants
Interval 32.5 to 51.0
|
47.5 percentage of participants
Interval 38.2 to 56.9
|
SECONDARY outcome
Timeframe: Randomization up to 37.52 monthsPopulation: Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.
DCR was defined as the percentage of randomized participants with overall response of CR, PR or SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared; SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD. PD defined as at least 20% increase in the sum of LD of target, lesions taking as reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions or progression of nontarget lesions.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
|
71.2 percentage of participants
Interval 62.1 to 79.2
|
64.4 percentage of participants
Interval 55.1 to 73.0
|
SECONDARY outcome
Timeframe: Randomization to the first date of measured PD up to 37.32 monthsPopulation: Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed + Cisplatin + Gefitinib (G) =37, G=26.
TtPD was defined as the time from randomization to the first date of objectively determined progressive disease (PD). For participants who were not known to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, or who had died without objective progression of disease, TtPD was censored at the date of the participant's last objective progression-free disease assessment prior to cut-off date.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=118 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Time to Progressive Disease (TtPD)
|
8.61 months
Interval 6.6 to 11.2
|
9.69 months
Interval 6.87 to 11.2
|
SECONDARY outcome
Timeframe: Date of initial response to the date of measured PD or death up to 34.43 monthsPopulation: A subset of the Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned who had confirmed CR or PR. Pemetrexed + Cisplatin + Gefitinib= 19, Gefitinib= 9.
The duration of a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria was defined as the time from first objective status assessment of CR or PR to the first time of objective disease progression or death as a result of any cause. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared. Participants who were not known to have died or had objective progression of disease as of the data-inclusion cut-off date were censored at the date of the participant's last complete objective progression-free disease assessment prior to that cut-off date.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=49 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=56 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Duration of Tumor Response
|
12.09 months
Interval 7.16 to 22.11
|
11.93 months
Interval 9.63 to 14.09
|
SECONDARY outcome
Timeframe: Every cycle while on-study therapy and at 3 months post last dosePopulation: Participants who received at least 1 dose of study treatment and had LCSS data available. Participants censored (Pemetrexed + Cisplatin + Gefitinib, Gefitinib): Loss of appetite (33,59), Fatigue (42,54), Cough (52,65), Dyspnea (51,66), Hemoptysis (69,74), Pain (48,67), Overall symptoms (52,63), Interference (42,59), Overall QoL (51,51).
The LCSS data included participant ratings of 6 symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) and 3 summary items (overall symptom severity, interference with daily activities, and overall QoL). Participants recorded their ratings for each item, by placing a mark on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (lower symptom burden, less interference with normal activity, or better QoL) to 100 mm (higher symptom burden, more interference with normal activity, or worse QoL). TWQ was evaluated from date of randomization to first date of worsening, defined as a half standard deviation change as determined from the corresponding baseline item score in the pooled treatment group. For participants not known to have worsened or who were lost to follow-up, TWQ was censored at date of the participant's last LCSS assessment.
Outcome measures
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=109 Participants
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=109 Participants
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Loss of appetite
|
2.99 months
Interval 1.71 to 3.68
|
7.95 months
Interval 4.9 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Fatigue
|
4.83 months
Interval 2.92 to 6.83
|
7.29 months
Interval 3.75 to 13.63
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Cough
|
8.57 months
Interval 5.68 to 10.94
|
16.69 months
Interval 6.51 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Dyspnea
|
6.97 months
Interval 3.15 to 15.44
|
18.23 months
Interval 7.06 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Hemoptysis
|
19.45 months
Interval 9.89 to
upper bound not generated due to small sample size
|
17.05 months
Interval 10.02 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Pain
|
6.44 months
Interval 2.92 to 11.4
|
15.57 months
Interval 9.95 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Overall symptoms
|
4.76 months
Interval 3.12 to 12.81
|
13.63 months
Interval 7.06 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Interference
|
4.50 months
Interval 3.02 to 7.03
|
8.34 months
Interval 4.9 to
upper bound not generated due to small sample size
|
|
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
Overall quality of life
|
6.14 months
Interval 3.52 to 12.78
|
6.93 months
Interval 3.22 to 13.63
|
Adverse Events
Pemetrexed + Cisplatin + Gefitinib
Serious events: 35 serious events
Other events: 111 other events
Deaths: 0 deaths
Gefitinib
Serious events: 32 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=114 participants at risk
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 participants at risk
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.7%
2/118 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/114 • Number of events 4
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Asthenia
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Fatigue
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Multi-organ failure
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Pyrexia
|
2.6%
3/114 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Device related infection
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Empyema
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Pneumonia
|
6.1%
7/114 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
7.6%
9/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Septic shock
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Wound infection
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Cervical cord compression
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Somnolence
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Personality change
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/84
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.1%
1/89 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
3/114 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
2.5%
3/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/114
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 4
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
2/114 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin + Gefitinib
n=114 participants at risk
Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
|
Gefitinib
n=118 participants at risk
Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
9/114 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 4
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.4%
21/114 • Number of events 46
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.4%
13/114 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.9%
7/118 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
7/114 • Number of events 11
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.7%
2/118 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
31.6%
36/114 • Number of events 52
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
12.7%
15/118 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
30/114 • Number of events 38
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
42.4%
50/118 • Number of events 68
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
4.2%
5/118 • Number of events 5
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
7/114 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.7%
2/118 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
61.4%
70/114 • Number of events 133
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
22.0%
26/118 • Number of events 27
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
10/114 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
10.2%
12/118 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
41/114 • Number of events 69
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
11.0%
13/118 • Number of events 14
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Asthenia
|
8.8%
10/114 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
2.5%
3/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Chest pain
|
7.9%
9/114 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.9%
7/118 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Fatigue
|
28.1%
32/114 • Number of events 49
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
17.8%
21/118 • Number of events 22
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Influenza like illness
|
7.0%
8/114 • Number of events 18
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.1%
6/118 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Mucosal inflammation
|
5.3%
6/114 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
10.2%
12/118 • Number of events 13
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Pyrexia
|
7.0%
8/114 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
11.0%
13/118 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Paronychia
|
7.9%
9/114 • Number of events 14
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
7.6%
9/118 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
9/114 • Number of events 12
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
6.8%
8/118 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
17.5%
20/114 • Number of events 23
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
25.4%
30/118 • Number of events 33
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
16/114 • Number of events 18
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
20.3%
24/118 • Number of events 30
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Blood creatinine increased
|
5.3%
6/114 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.7%
2/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Haemoglobin decreased
|
11.4%
13/114 • Number of events 15
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Neutrophil count decreased
|
12.3%
14/114 • Number of events 28
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.00%
0/118
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
White blood cell count decreased
|
7.0%
8/114 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
0.85%
1/118 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.7%
43/114 • Number of events 57
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
24.6%
29/118 • Number of events 32
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
9.3%
11/118 • Number of events 16
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
7/114 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
8.5%
10/118 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
15/114 • Number of events 17
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
8.5%
10/118 • Number of events 10
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 5
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
7/114 • Number of events 11
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.9%
7/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.1%
6/118 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Dizziness
|
18.4%
21/114 • Number of events 22
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
13.6%
16/118 • Number of events 19
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Headache
|
15.8%
18/114 • Number of events 23
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
13.6%
16/118 • Number of events 19
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.3%
14/114 • Number of events 14
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
1.7%
2/118 • Number of events 2
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.5%
12/114 • Number of events 14
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
3.4%
4/118 • Number of events 5
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Insomnia
|
12.3%
14/114 • Number of events 14
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
9.3%
11/118 • Number of events 12
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
25/114 • Number of events 33
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
17.8%
21/118 • Number of events 23
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
17/114 • Number of events 19
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
16.9%
20/118 • Number of events 21
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.3%
6/114 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
6.8%
8/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.3%
6/114 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
2.5%
3/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
6/114 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
6.8%
8/118 • Number of events 11
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.4%
13/114 • Number of events 15
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
14.4%
17/118 • Number of events 20
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.6%
11/114 • Number of events 11
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
6.8%
8/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.0%
8/114 • Number of events 8
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
10.2%
12/118 • Number of events 12
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
16/114 • Number of events 18
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
7.6%
9/118 • Number of events 9
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
9.6%
11/114 • Number of events 12
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
16.9%
20/118 • Number of events 23
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
10/114 • Number of events 12
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
21.2%
25/118 • Number of events 27
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.4%
5/114 • Number of events 5
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.9%
7/118 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.9%
7/118 • Number of events 7
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.8%
34/114 • Number of events 43
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
32.2%
38/118 • Number of events 47
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.6%
36/114 • Number of events 51
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
44.1%
52/118 • Number of events 72
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.88%
1/114 • Number of events 1
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.1%
6/118 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
2.6%
3/114 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
5.1%
6/118 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
|
Vascular disorders
Hypertension
|
5.3%
6/114 • Number of events 6
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
2.5%
3/118 • Number of events 3
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60