Trial Outcomes & Findings for Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer (NCT NCT00126581)
NCT ID: NCT00126581
Last Updated: 2019-08-07
Results Overview
The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
At 18 weeks
Results posted on
2019-08-07
Participant Flow
Between August 2005 and April 2009, 188 participants were enrolled.
Seven participants withdrew consent before initiating study therapy, therefore, 181 participants were randomized to either arm.
Participant milestones
| Measure |
Arm A: Erlotinib
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
100
|
|
Overall Study
COMPLETED
|
68
|
80
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
Reasons for withdrawal
| Measure |
Arm A: Erlotinib
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
7
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Alternative therapy
|
3
|
3
|
|
Overall Study
Other illness/MD discretion
|
3
|
4
|
Baseline Characteristics
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Erlotinib
n=81 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=100 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
100 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
ECOG Performance Status
0 - fully active
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
ECOG Performance Status
1 - minimal symptoms
|
31 participants
n=5 Participants
|
52 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Smoking history
Never smoker
|
64 participants
n=5 Participants
|
79 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Smoking history
Light former smoker
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
71 participants
n=5 Participants
|
84 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Histology
Bronhioloalveolar cancer
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Histology
Adenocarcinoma with bronchioloalveolar features
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 18 weeksThe product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.
Outcome measures
| Measure |
Arm A: Erlotinib
n=81 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=100 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
18 Weeks Progression Free Survival (PFS) Rate
|
52 percentage of participants
The 80% Confidence Interval was computed = (45, 59).
|
69 percentage of participants
The 80% Confidence Interval was computed = (62, 74).
|
SECONDARY outcome
Timeframe: Duration of Study (up to 3 years)The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions
Outcome measures
| Measure |
Arm A: Erlotinib
n=81 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=100 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Response Rate
|
35 percentage of participants
Interval 24.0 to 46.0
|
46 percentage of participants
Interval 36.0 to 56.0
|
SECONDARY outcome
Timeframe: Duration of study (up to 3 years)The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Outcome measures
| Measure |
Arm A: Erlotinib
n=81 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=99 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.
|
20 participants
|
52 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from randomization to death (up to 3 years)Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm A: Erlotinib
n=81 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=100 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Survival
|
24.6 months
Interval 18.4 to 33.8
|
19.8 months
Interval 14.4 to 27.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of treatment (up to 3 years)Population: EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.
PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome.
Outcome measures
| Measure |
Arm A: Erlotinib
n=77 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=87 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status
EGFR Mutant
|
14.1 months
Interval 7.0 to 19.6
|
17.2 months
Interval 8.2 to 28.7
|
|
Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status
EGFR Wild Type
|
2.6 months
Interval 1.4 to 3.9
|
4.8 months
Interval 2.8 to 5.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of study (up to 3 years)Population: EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.
Response and EGFR mutation status are defined in previous outcome measures.
Outcome measures
| Measure |
Arm A: Erlotinib
n=77 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=87 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Response Rate by EGFR Mutation Status
EGFR Mutant
|
70 percentage of participants
Interval 51.0 to 84.0
|
73 percentage of participants
Interval 18.0 to 44.0
|
|
Overall Response Rate by EGFR Mutation Status
EGFR Wild Type
|
9 percentage of participants
Interval 3.0 to 22.0
|
30 percentage of participants
Interval 18.0 to 44.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of study (up to 3 years)Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.
Outcome measures
| Measure |
Arm A: Erlotinib
n=17 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=147 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Progression Free Survival With KRAS Mutation Status
|
4 months
Interval 2.8 to 12.4
|
6.7 months
Interval 5.3 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of study (up to 3 years)Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.
Outcome measures
| Measure |
Arm A: Erlotinib
n=17 Participants
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=147 Participants
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Overall Response Rate With KRAS Mutational Status
|
29 percentage of participants
Interval 10.0 to 56.0
|
42 percentage of participants
Interval 34.0 to 51.0
|
Adverse Events
Arm A: Erlotinib
Serious events: 21 serious events
Other events: 78 other events
Deaths: 0 deaths
Arm B: Erlotinib/Carboplatin/Paclitaxel
Serious events: 39 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Erlotinib
n=81 participants at risk
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=99 participants at risk
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/81
|
8.1%
8/99 • Number of events 9
|
|
Blood and lymphatic system disorders
Hemoglobin
|
11.1%
9/81 • Number of events 10
|
20.2%
20/99 • Number of events 25
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Cardiac General - Other
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Eye disorders
Watery eye (epiphora tearing)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/81 • Number of events 3
|
7.1%
7/99 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
9.9%
8/81 • Number of events 9
|
20.2%
20/99 • Number of events 26
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
2/81 • Number of events 3
|
3.0%
3/99 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/81
|
3.0%
3/99 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
2.5%
2/81 • Number of events 2
|
4.0%
4/99 • Number of events 5
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
2.5%
2/81 • Number of events 3
|
4.0%
4/99 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
6.2%
5/81 • Number of events 5
|
21.2%
21/99 • Number of events 25
|
|
Gastrointestinal disorders
Pain
|
7.4%
6/81 • Number of events 6
|
6.1%
6/99 • Number of events 6
|
|
Gastrointestinal disorders
Ulcer GI
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
5/81 • Number of events 5
|
12.1%
12/99 • Number of events 14
|
|
General disorders
Death not associated with CTCAE term
|
3.7%
3/81 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
|
General disorders
Edema: limb
|
4.9%
4/81 • Number of events 4
|
3.0%
3/99 • Number of events 3
|
|
General disorders
Edema: viscera
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Fatigue
|
12.3%
10/81 • Number of events 12
|
25.3%
25/99 • Number of events 34
|
|
General disorders
Fever
|
4.9%
4/81 • Number of events 4
|
6.1%
6/99 • Number of events 6
|
|
General disorders
Pain - Other
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
General disorders
Rigors/chills
|
2.5%
2/81 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Infection
|
2.5%
2/81 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
2.5%
2/81 • Number of events 2
|
5.1%
5/99 • Number of events 5
|
|
Infections and infestations
Infection with unknown ANC
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
1.2%
1/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.2%
1/81 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
2/81 • Number of events 2
|
5.1%
5/99 • Number of events 6
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Investigations
Amylase
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
5/81 • Number of events 5
|
8.1%
8/99 • Number of events 11
|
|
Investigations
Blood bilirubin increased
|
4.9%
4/81 • Number of events 4
|
7.1%
7/99 • Number of events 9
|
|
Investigations
CPK (creatine phosphokinase)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Creatinine
|
1.2%
1/81 • Number of events 1
|
7.1%
7/99 • Number of events 8
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
2.5%
2/81 • Number of events 2
|
6.1%
6/99 • Number of events 8
|
|
Investigations
Leukocytes (total WBC)
|
1.2%
1/81 • Number of events 1
|
24.2%
24/99 • Number of events 25
|
|
Investigations
Lipase increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Lymphopenia
|
2.5%
2/81 • Number of events 2
|
9.1%
9/99 • Number of events 13
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/81
|
19.2%
19/99 • Number of events 19
|
|
Investigations
Platelet count decreased
|
2.5%
2/81 • Number of events 2
|
14.1%
14/99 • Number of events 18
|
|
Investigations
Weight loss
|
2.5%
2/81 • Number of events 2
|
4.0%
4/99 • Number of events 4
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
7.4%
6/81 • Number of events 6
|
10.1%
10/99 • Number of events 13
|
|
Metabolism and nutrition disorders
Anorexia
|
8.6%
7/81 • Number of events 8
|
13.1%
13/99 • Number of events 17
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 2
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
1.2%
1/81 • Number of events 1
|
9.1%
9/99 • Number of events 11
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/81
|
9.1%
9/99 • Number of events 9
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
1.2%
1/81 • Number of events 1
|
12.1%
12/99 • Number of events 15
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
1.2%
1/81 • Number of events 1
|
8.1%
8/99 • Number of events 12
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
0.00%
0/81
|
4.0%
4/99 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
1.2%
1/81 • Number of events 1
|
4.0%
4/99 • Number of events 4
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
2.5%
2/81 • Number of events 2
|
6.1%
6/99 • Number of events 8
|
|
Metabolism and nutrition disorders
Sodium serum-high (hypernatremia)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
3.7%
3/81 • Number of events 3
|
11.1%
11/99 • Number of events 11
|
|
Metabolism and nutrition disorders
Triglyceride serum-high (hypertriglyceridemia)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
2/81 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
3/81 • Number of events 3
|
3.0%
3/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/81 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
|
Nervous system disorders
Ataxia
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
1.2%
1/81 • Number of events 2
|
7.1%
7/99 • Number of events 9
|
|
Nervous system disorders
Headache
|
2.5%
2/81 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
2/81 • Number of events 2
|
20.2%
20/99 • Number of events 30
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/81
|
3.0%
3/99 • Number of events 3
|
|
Psychiatric disorders
Depression
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.5%
2/81 • Number of events 3
|
4.0%
4/99 • Number of events 5
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage GU
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
1.2%
1/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
2.5%
2/81 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
5/81 • Number of events 5
|
10.1%
10/99 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.6%
11/81 • Number of events 11
|
12.1%
12/99 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/81 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/81 • Number of events 2
|
13.1%
13/99 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
2.5%
2/81 • Number of events 3
|
2.0%
2/99 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/81
|
4.0%
4/99 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.5%
2/81 • Number of events 2
|
9.1%
9/99 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
18.5%
15/81 • Number of events 16
|
16.2%
16/99 • Number of events 22
|
|
Vascular disorders
Flushing
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.00%
0/81
|
3.0%
3/99 • Number of events 3
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.7%
3/81 • Number of events 3
|
9.1%
9/99 • Number of events 9
|
Other adverse events
| Measure |
Arm A: Erlotinib
n=81 participants at risk
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm B: Erlotinib/Carboplatin/Paclitaxel
n=99 participants at risk
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
1.2%
1/81 • Number of events 7
|
0.00%
0/99
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
1/81 • Number of events 1
|
6.1%
6/99 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
23.5%
19/81 • Number of events 89
|
62.6%
62/99 • Number of events 357
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
0.00%
0/81
|
5.1%
5/99 • Number of events 7
|
|
Cardiac disorders
Palpitations
|
2.5%
2/81 • Number of events 4
|
2.0%
2/99 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/81 • Number of events 4
|
0.00%
0/99
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/81
|
1.0%
1/99 • Number of events 3
|
|
Ear and labyrinth disorders
Otitis external ear (non-infectious)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/81 • Number of events 8
|
5.1%
5/99 • Number of events 8
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
2/81 • Number of events 8
|
2.0%
2/99 • Number of events 9
|
|
Eye disorders
Cataract
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/81
|
3.0%
3/99 • Number of events 6
|
|
Eye disorders
Dry eye syndrome
|
9.9%
8/81 • Number of events 30
|
5.1%
5/99 • Number of events 54
|
|
Eye disorders
Eye pain
|
2.5%
2/81 • Number of events 2
|
0.00%
0/99
|
|
Eye disorders
Eyelid dysfunction
|
2.5%
2/81 • Number of events 4
|
3.0%
3/99 • Number of events 4
|
|
Eye disorders
Keratitis
|
2.5%
2/81 • Number of events 30
|
0.00%
0/99
|
|
Eye disorders
Ocular/Visual - Other
|
3.7%
3/81 • Number of events 6
|
3.0%
3/99 • Number of events 12
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Eye disorders
Photophobia
|
3.7%
3/81 • Number of events 21
|
1.0%
1/99 • Number of events 1
|
|
Eye disorders
Retinopathy
|
1.2%
1/81 • Number of events 2
|
0.00%
0/99
|
|
Eye disorders
Vision-blurred vision
|
4.9%
4/81 • Number of events 6
|
6.1%
6/99 • Number of events 12
|
|
Eye disorders
Vision-flashing lights/floaters
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Eye disorders
Watery eye (epiphora tearing)
|
1.2%
1/81 • Number of events 4
|
2.0%
2/99 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/81 • Number of events 4
|
0.00%
0/99
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/81
|
2.0%
2/99 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
19.8%
16/81 • Number of events 99
|
34.3%
34/99 • Number of events 97
|
|
Gastrointestinal disorders
Dental: teeth
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
81.5%
66/81 • Number of events 480
|
76.8%
76/99 • Number of events 401
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
7/81 • Number of events 42
|
9.1%
9/99 • Number of events 68
|
|
Gastrointestinal disorders
Dyspepsia
|
21.0%
17/81 • Number of events 68
|
18.2%
18/99 • Number of events 60
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
4/81 • Number of events 4
|
11.1%
11/99 • Number of events 15
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/81 • Number of events 5
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.7%
3/81 • Number of events 6
|
1.0%
1/99 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/81
|
1.0%
1/99 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
2.5%
2/81 • Number of events 12
|
3.0%
3/99 • Number of events 5
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.5%
2/81 • Number of events 4
|
4.0%
4/99 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
6.2%
5/81 • Number of events 15
|
11.1%
11/99 • Number of events 18
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
16.0%
13/81 • Number of events 109
|
16.2%
16/99 • Number of events 37
|
|
Gastrointestinal disorders
Nausea
|
40.7%
33/81 • Number of events 127
|
53.5%
53/99 • Number of events 156
|
|
Gastrointestinal disorders
Oral pain
|
7.4%
6/81 • Number of events 15
|
3.0%
3/99 • Number of events 4
|
|
Gastrointestinal disorders
Pain
|
19.8%
16/81 • Number of events 65
|
24.2%
24/99 • Number of events 84
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
2.5%
2/81 • Number of events 6
|
0.00%
0/99
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic) GI
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
12/81 • Number of events 18
|
27.3%
27/99 • Number of events 50
|
|
General disorders
Constitutional Symptoms - Other
|
1.2%
1/81 • Number of events 12
|
2.0%
2/99 • Number of events 2
|
|
General disorders
Death not associated with CTCAE term
|
4.9%
4/81 • Number of events 7
|
1.0%
1/99 • Number of events 1
|
|
General disorders
Edema: limb
|
11.1%
9/81 • Number of events 39
|
12.1%
12/99 • Number of events 26
|
|
General disorders
Edema:head and neck
|
2.5%
2/81 • Number of events 3
|
0.00%
0/99
|
|
General disorders
Facial pain
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
General disorders
Fatigue
|
54.3%
44/81 • Number of events 350
|
79.8%
79/99 • Number of events 528
|
|
General disorders
Fever
|
7.4%
6/81 • Number of events 6
|
8.1%
8/99 • Number of events 11
|
|
General disorders
Flu-like syndrome
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
General disorders
Injection site reaction/extravasation changes
|
0.00%
0/81
|
1.0%
1/99 • Number of events 5
|
|
General disorders
Pain - Other
|
8.6%
7/81 • Number of events 28
|
8.1%
8/99 • Number of events 17
|
|
General disorders
Rigors/chills
|
7.4%
6/81 • Number of events 6
|
3.0%
3/99 • Number of events 11
|
|
General disorders
Syndromes - Other
|
0.00%
0/81
|
3.0%
3/99 • Number of events 5
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Hepatobiliary disorders
Gallbladder pain
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 5
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
3.7%
3/81 • Number of events 6
|
14.1%
14/99 • Number of events 20
|
|
Immune system disorders
Autoimmune reaction
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Infection
|
14.8%
12/81 • Number of events 26
|
17.2%
17/99 • Number of events 31
|
|
Infections and infestations
Infection - Other
|
4.9%
4/81 • Number of events 6
|
5.1%
5/99 • Number of events 15
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
17.3%
14/81 • Number of events 40
|
13.1%
13/99 • Number of events 53
|
|
Infections and infestations
Infection with unknown ANC
|
3.7%
3/81 • Number of events 6
|
5.1%
5/99 • Number of events 7
|
|
Infections and infestations
Infection without neutropenia
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Prostate infection
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.2%
1/81 • Number of events 3
|
1.0%
1/99 • Number of events 7
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.5%
2/81 • Number of events 43
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/81
|
2.0%
2/99 • Number of events 4
|
|
Injury, poisoning and procedural complications
Intra-operative injury
|
1.2%
1/81 • Number of events 4
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Injury, poisoning and procedural complications
Vessel injury-vein
|
0.00%
0/81
|
1.0%
1/99 • Number of events 4
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
23.5%
19/81 • Number of events 50
|
18.2%
18/99 • Number of events 48
|
|
Investigations
Alkaline phosphatase
|
16.0%
13/81 • Number of events 31
|
19.2%
19/99 • Number of events 65
|
|
Investigations
Amylase
|
0.00%
0/81
|
1.0%
1/99 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
18/81 • Number of events 74
|
39.4%
39/99 • Number of events 91
|
|
Investigations
Blood bilirubin increased
|
23.5%
19/81 • Number of events 137
|
32.3%
32/99 • Number of events 214
|
|
Investigations
Cholesterol serum-high (hypercholesteremia)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Creatinine
|
16.0%
13/81 • Number of events 45
|
18.2%
18/99 • Number of events 119
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Haptoglobin
|
0.00%
0/81
|
1.0%
1/99 • Number of events 2
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
1.2%
1/81 • Number of events 1
|
12.1%
12/99 • Number of events 21
|
|
Investigations
Leukocytes (total WBC)
|
12.3%
10/81 • Number of events 56
|
63.6%
63/99 • Number of events 259
|
|
Investigations
Lipase increased
|
0.00%
0/81
|
1.0%
1/99 • Number of events 5
|
|
Investigations
Lymphopenia
|
9.9%
8/81 • Number of events 72
|
18.2%
18/99 • Number of events 69
|
|
Investigations
Metabolic/Laboratory - Other
|
1.2%
1/81 • Number of events 3
|
3.0%
3/99 • Number of events 6
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.5%
2/81 • Number of events 11
|
45.5%
45/99 • Number of events 117
|
|
Investigations
Platelet count decreased
|
6.2%
5/81 • Number of events 62
|
43.4%
43/99 • Number of events 123
|
|
Investigations
Weight loss
|
3.7%
3/81 • Number of events 4
|
13.1%
13/99 • Number of events 29
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
18.5%
15/81 • Number of events 46
|
25.3%
25/99 • Number of events 115
|
|
Metabolism and nutrition disorders
Anorexia
|
38.3%
31/81 • Number of events 94
|
35.4%
35/99 • Number of events 120
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/81
|
2.0%
2/99 • Number of events 5
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
4.9%
4/81 • Number of events 24
|
2.0%
2/99 • Number of events 2
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
7.4%
6/81 • Number of events 10
|
15.2%
15/99 • Number of events 27
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/81 • Number of events 1
|
7.1%
7/99 • Number of events 14
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
18.5%
15/81 • Number of events 41
|
33.3%
33/99 • Number of events 105
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
0.00%
0/81
|
5.1%
5/99 • Number of events 5
|
|
Metabolism and nutrition disorders
Magnesium serum-high (hypermagnesemia)
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 2
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
8.6%
7/81 • Number of events 14
|
18.2%
18/99 • Number of events 77
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
1.2%
1/81 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
13.6%
11/81 • Number of events 33
|
7.1%
7/99 • Number of events 10
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
19.8%
16/81 • Number of events 31
|
20.2%
20/99 • Number of events 60
|
|
Metabolism and nutrition disorders
Sodium serum-high (hypernatremia)
|
1.2%
1/81 • Number of events 1
|
5.1%
5/99 • Number of events 5
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
7.4%
6/81 • Number of events 19
|
17.2%
17/99 • Number of events 47
|
|
Metabolism and nutrition disorders
Triglyceride serum-high (hypertriglyceridemia)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.8%
16/81 • Number of events 107
|
21.2%
21/99 • Number of events 88
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.5%
2/81 • Number of events 11
|
2.0%
2/99 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
12/81 • Number of events 35
|
16.2%
16/99 • Number of events 91
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.3%
10/81 • Number of events 46
|
10.1%
10/99 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.2%
1/81 • Number of events 2
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.9%
8/81 • Number of events 26
|
9.1%
9/99 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/81
|
1.0%
1/99 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
3.7%
3/81 • Number of events 3
|
2.0%
2/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
2.5%
2/81 • Number of events 3
|
7.1%
7/99 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.3%
10/81 • Number of events 51
|
21.2%
21/99 • Number of events 39
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
2/81 • Number of events 9
|
4.0%
4/99 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
9/81 • Number of events 36
|
14.1%
14/99 • Number of events 33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/81
|
3.0%
3/99 • Number of events 7
|
|
Nervous system disorders
Depressed level of consciousness
|
1.2%
1/81 • Number of events 3
|
0.00%
0/99
|
|
Nervous system disorders
Dizziness
|
12.3%
10/81 • Number of events 25
|
17.2%
17/99 • Number of events 28
|
|
Nervous system disorders
Dysgeusia
|
12.3%
10/81 • Number of events 58
|
23.2%
23/99 • Number of events 84
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.2%
1/81 • Number of events 14
|
0.00%
0/99
|
|
Nervous system disorders
Headache
|
14.8%
12/81 • Number of events 65
|
12.1%
12/99 • Number of events 28
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
0.00%
0/81
|
1.0%
1/99 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/81 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/81
|
2.0%
2/99 • Number of events 7
|
|
Nervous system disorders
Neuropathy: cranial
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
3/81 • Number of events 10
|
4.0%
4/99 • Number of events 8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
18/81 • Number of events 78
|
58.6%
58/99 • Number of events 632
|
|
Nervous system disorders
Seizure
|
1.2%
1/81 • Number of events 2
|
1.0%
1/99 • Number of events 2
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Vasovagal episode
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Psychiatric disorders
Agitation
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
17.3%
14/81 • Number of events 53
|
8.1%
8/99 • Number of events 53
|
|
Psychiatric disorders
Confusion
|
2.5%
2/81 • Number of events 5
|
3.0%
3/99 • Number of events 3
|
|
Psychiatric disorders
Depression
|
6.2%
5/81 • Number of events 25
|
11.1%
11/99 • Number of events 49
|
|
Psychiatric disorders
Insomnia
|
21.0%
17/81 • Number of events 99
|
24.2%
24/99 • Number of events 85
|
|
Psychiatric disorders
Personality change
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/81
|
1.0%
1/99 • Number of events 4
|
|
Renal and urinary disorders
Hemorrhage GU
|
0.00%
0/81
|
2.0%
2/99 • Number of events 2
|
|
Renal and urinary disorders
Obstruction, GU
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.5%
2/81 • Number of events 3
|
3.0%
3/99 • Number of events 4
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/81
|
1.0%
1/99 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.5%
2/81 • Number of events 25
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
1.2%
1/81 • Number of events 2
|
0.00%
0/99
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Reproductive system and breast disorders
Breast pain
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Reproductive system and breast disorders
Ejaculatory dysfunction
|
0.00%
0/81
|
1.0%
1/99 • Number of events 2
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/81
|
2.0%
2/99 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.2%
1/81 • Number of events 4
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
12.3%
10/81 • Number of events 73
|
9.1%
9/99 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
1.2%
1/81 • Number of events 2
|
2.0%
2/99 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.3%
44/81 • Number of events 174
|
45.5%
45/99 • Number of events 142
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
2/81 • Number of events 2
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
38.3%
31/81 • Number of events 158
|
35.4%
35/99 • Number of events 92
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
9/81 • Number of events 29
|
10.1%
10/99 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
3.7%
3/81 • Number of events 3
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/81 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/81
|
4.0%
4/99 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.5%
2/81 • Number of events 3
|
6.1%
6/99 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.7%
3/81 • Number of events 8
|
2.0%
2/99 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.5%
2/81 • Number of events 2
|
1.0%
1/99 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
8.6%
7/81 • Number of events 29
|
5.1%
5/99 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
|
0.00%
0/81
|
7.1%
7/99 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
18/81 • Number of events 103
|
58.6%
58/99 • Number of events 325
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
13.6%
11/81 • Number of events 46
|
11.1%
11/99 • Number of events 65
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.9%
25/81 • Number of events 232
|
29.3%
29/99 • Number of events 144
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
16.0%
13/81 • Number of events 80
|
11.1%
11/99 • Number of events 113
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.5%
2/81 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.5%
2/81 • Number of events 4
|
2.0%
2/99 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.3%
10/81 • Number of events 99
|
11.1%
11/99 • Number of events 32
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
29.6%
24/81 • Number of events 131
|
42.4%
42/99 • Number of events 180
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
85.2%
69/81 • Number of events 632
|
73.7%
73/99 • Number of events 806
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
3.7%
3/81 • Number of events 27
|
4.0%
4/99 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.7%
3/81 • Number of events 4
|
0.00%
0/99
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/81
|
3.0%
3/99 • Number of events 4
|
|
Vascular disorders
Flushing
|
1.2%
1/81 • Number of events 1
|
0.00%
0/99
|
|
Vascular disorders
Hematoma
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
1.2%
1/81 • Number of events 2
|
3.0%
3/99 • Number of events 12
|
|
Vascular disorders
Hot flashes/flushes
|
1.2%
1/81 • Number of events 1
|
2.0%
2/99 • Number of events 4
|
|
Vascular disorders
Hypertension
|
9.9%
8/81 • Number of events 97
|
7.1%
7/99 • Number of events 35
|
|
Vascular disorders
Hypotension
|
0.00%
0/81
|
3.0%
3/99 • Number of events 3
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.00%
0/81
|
2.0%
2/99 • Number of events 4
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.7%
3/81 • Number of events 3
|
3.0%
3/99 • Number of events 5
|
|
Vascular disorders
Vascular - Other
|
0.00%
0/81
|
1.0%
1/99 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60