Trial Outcomes & Findings for Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer (NCT NCT00520676)
NCT ID: NCT00520676
Last Updated: 2011-08-10
Results Overview
Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
COMPLETED
PHASE3
260 participants
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
2011-08-10
Participant Flow
Analyses were conducted on the qualified intent-to-treat population (Q-ITT) unless otherwise specified. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Participant milestones
| Measure |
Pemetrexed Plus Carboplatin
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
132
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
118
|
127
|
|
Overall Study
Qualified Intent-to-treat (Q-ITT)
|
106
|
105
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
101
|
103
|
Reasons for withdrawal
| Measure |
Pemetrexed Plus Carboplatin
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Overall Study
Death
|
84
|
81
|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
|
Overall Study
Physician Decision
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
11
|
Baseline Characteristics
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
35 participants
n=5 Participants
|
25 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
China
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Smoking Status
Never Smoking
|
34 participants
n=5 Participants
|
41 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Smoking Status
Ever Smoking but Quit
|
61 participants
n=5 Participants
|
53 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Smoking Status
Currently Smoking
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Histology
Adenocarcinoma, lung
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Histology
Adenocarcinoma, not otherwise specified
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Histology
Large cell carcinoma, lung
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Histology
Carcinoma, lung
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Survival Without Grade 3 or 4 Toxicity
|
3.2 months
Interval 2.1 to 3.7
|
0.7 months
Interval 0.5 to 1.2
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Overall Survival (OS)
|
14.9 months
Interval 12.2 to 19.0
|
14.7 months
Interval 10.8 to 19.8
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.8 months
Interval 4.8 to 6.4
|
6.0 months
Interval 4.8 to 6.6
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed \*100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed \*100.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=104 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Percentage of Participants With Tumor Response (Response Rate)
Tumor Response Rate
|
34.0 percentage of participants
Interval 25.0 to 43.8
|
23.1 percentage of participants
Interval 15.4 to 32.4
|
|
Percentage of Participants With Tumor Response (Response Rate)
Disease Control Rate
|
74.5 percentage of participants
Interval 65.1 to 82.5
|
64.4 percentage of participants
Interval 54.4 to 73.6
|
|
Percentage of Participants With Tumor Response (Response Rate)
Complete Response
|
0.9 percentage of participants
Interval 0.0 to 5.1
|
0 percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants With Tumor Response (Response Rate)
Partial Response
|
33.0 percentage of participants
Interval 24.2 to 42.8
|
23.1 percentage of participants
Interval 15.4 to 32.4
|
|
Percentage of Participants With Tumor Response (Response Rate)
Stable Disease
|
40.6 percentage of participants
Interval 31.1 to 50.5
|
41.3 percentage of participants
Interval 31.8 to 51.4
|
|
Percentage of Participants With Tumor Response (Response Rate)
Progressive Disease
|
16.0 percentage of participants
Interval 9.6 to 24.4
|
17.3 percentage of participants
Interval 10.6 to 26.0
|
|
Percentage of Participants With Tumor Response (Response Rate)
Unknown
|
9.4 percentage of participants
Interval 4.6 to 16.7
|
18.3 percentage of participants
Interval 11.4 to 27.1
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.
Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0: neutropenia (lasting \>5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Survival Without Clinically Important Grade 3 or 4 Toxicity
|
3.6 months
Interval 3.0 to 8.0
|
1.3 months
Interval 1.1 to 1.9
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Survival Without Grade 4 Toxicity
|
12.2 participants
Interval 8.4 to 14.9
|
2.0 participants
Interval 1.6 to 3.8
|
SECONDARY outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.
Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Non-Serious Adverse Events (AEs)
|
94 participants
|
100 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Events (SAEs)
|
28 participants
|
35 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).Population: Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Pemetrexed Plus Carboplatin
n=106 Participants
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=104 Participants
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Duration of Response
|
5.5 months
Interval 4.0 to 8.1
|
5.4 months
Interval 4.4 to 6.7
|
Adverse Events
Pemetrexed Plus Carboplatin
Docetaxel Plus Carboplatin
Serious adverse events
| Measure |
Pemetrexed Plus Carboplatin
n=106 participants at risk
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 participants at risk
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/106 • Number of events 2
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/106
|
8.6%
9/105 • Number of events 10
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.94%
1/106 • Number of events 1
|
2.9%
3/105 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/106 • Number of events 2
|
7.6%
8/105 • Number of events 9
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.9%
2/106 • Number of events 2
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
3/106 • Number of events 3
|
1.9%
2/105 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/106
|
2.9%
3/105 • Number of events 3
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Cor pulmonale
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Cardiac disorders
Tachycardia
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/106
|
2.9%
3/105 • Number of events 3
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.94%
1/106 • Number of events 1
|
1.9%
2/105 • Number of events 2
|
|
General disorders
Asthenia
|
0.94%
1/106 • Number of events 1
|
1.9%
2/105 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
General disorders
Death
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
General disorders
Pain
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
General disorders
Pyrexia
|
0.94%
1/106 • Number of events 1
|
1.9%
2/105 • Number of events 2
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Infections and infestations
Device related infection
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.7%
5/106 • Number of events 5
|
6.7%
7/105 • Number of events 7
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Investigations
Platelet count decreased
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Investigations
Troponin increased
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Cerebrovascular accident
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Convulsion
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Neuralgia
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/106
|
2.9%
3/105 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/106
|
2.9%
3/105 • Number of events 3
|
|
Vascular disorders
Arterial occlusive disease
|
0.94%
1/106 • Number of events 1
|
0.00%
0/105
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
2/106 • Number of events 2
|
0.00%
0/105
|
|
Vascular disorders
Hypotension
|
0.00%
0/106
|
0.95%
1/105 • Number of events 1
|
|
Vascular disorders
Superior vena caval occlusion
|
0.94%
1/106 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed Plus Carboplatin
n=106 participants at risk
pemetrexed 500 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
Docetaxel Plus Carboplatin
n=105 participants at risk
docetaxel 75 mg/m\^2 plus carboplatin AUC 5 mg\*min/mL on Day 1 every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.0%
36/106 • Number of events 46
|
17.1%
18/105 • Number of events 25
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.1%
33/106 • Number of events 80
|
53.3%
56/105 • Number of events 139
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.2%
14/106 • Number of events 26
|
23.8%
25/105 • Number of events 38
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.7%
40/106 • Number of events 109
|
70.5%
74/105 • Number of events 203
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.3%
12/106 • Number of events 23
|
3.8%
4/105 • Number of events 6
|
|
Cardiac disorders
Arrhythmia
|
2.8%
3/106 • Number of events 3
|
5.7%
6/105 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
11/106 • Number of events 14
|
12.4%
13/105 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
17.0%
18/106 • Number of events 23
|
14.3%
15/105 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
12/106 • Number of events 21
|
28.6%
30/105 • Number of events 43
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
5/106 • Number of events 6
|
6.7%
7/105 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
40.6%
43/106 • Number of events 71
|
35.2%
37/105 • Number of events 66
|
|
Gastrointestinal disorders
Stomatitis
|
8.5%
9/106 • Number of events 17
|
10.5%
11/105 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
18/106 • Number of events 22
|
18.1%
19/105 • Number of events 31
|
|
General disorders
Asthenia
|
14.2%
15/106 • Number of events 20
|
18.1%
19/105 • Number of events 30
|
|
General disorders
Chest pain
|
3.8%
4/106 • Number of events 4
|
6.7%
7/105 • Number of events 7
|
|
General disorders
Fatigue
|
12.3%
13/106 • Number of events 15
|
20.0%
21/105 • Number of events 24
|
|
General disorders
Mucosal inflammation
|
6.6%
7/106 • Number of events 11
|
4.8%
5/105 • Number of events 7
|
|
General disorders
Oedema
|
3.8%
4/106 • Number of events 4
|
5.7%
6/105 • Number of events 6
|
|
General disorders
Pyrexia
|
10.4%
11/106 • Number of events 12
|
6.7%
7/105 • Number of events 15
|
|
Infections and infestations
Conjunctivitis infective
|
6.6%
7/106 • Number of events 8
|
0.00%
0/105
|
|
Infections and infestations
Nail infection
|
0.00%
0/106
|
6.7%
7/105 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
9/106 • Number of events 11
|
2.9%
3/105 • Number of events 3
|
|
Investigations
Platelet count decreased
|
6.6%
7/106 • Number of events 13
|
4.8%
5/105 • Number of events 11
|
|
Investigations
Weight decreased
|
2.8%
3/106 • Number of events 3
|
5.7%
6/105 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.5%
27/106 • Number of events 37
|
28.6%
30/105 • Number of events 35
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
4/106 • Number of events 4
|
5.7%
6/105 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
3/106 • Number of events 3
|
7.6%
8/105 • Number of events 11
|
|
Nervous system disorders
Dizziness
|
6.6%
7/106 • Number of events 8
|
6.7%
7/105 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
6.6%
7/106 • Number of events 12
|
10.5%
11/105 • Number of events 15
|
|
Nervous system disorders
Headache
|
7.5%
8/106 • Number of events 9
|
6.7%
7/105 • Number of events 9
|
|
Nervous system disorders
Neurotoxicity
|
1.9%
2/106 • Number of events 2
|
6.7%
7/105 • Number of events 11
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/106
|
6.7%
7/105 • Number of events 8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.6%
7/106 • Number of events 10
|
13.3%
14/105 • Number of events 18
|
|
Psychiatric disorders
Insomnia
|
6.6%
7/106 • Number of events 7
|
5.7%
6/105 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
13/106 • Number of events 14
|
7.6%
8/105 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
10/106 • Number of events 10
|
9.5%
10/105 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
8/106 • Number of events 9
|
1.9%
2/105 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.4%
10/106 • Number of events 11
|
42.9%
45/105 • Number of events 46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
7/106 • Number of events 8
|
4.8%
5/105 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
8/106 • Number of events 9
|
8.6%
9/105 • Number of events 9
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60