A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01998919
Collaborator
(none)
154
19
2
63
8.1
0.1
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tarceva + gemcitabine/platinum
|
Drug: erlotinib [Tarceva]
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
Drug: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Drug: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Drug: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
|
| Placebo Comparator: Placebo + gemcitabine/platinum
|
Drug: placebo
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
Drug: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Drug: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Drug: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [Week 8]
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Secondary Outcome Measures
- Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST [Week 16]
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.
- Percentage of Participants With Confirmed CR or PR as Assessed by RECIST [Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases]
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
- Duration of Response [Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases]
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
- Time to Progression [Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases]
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
- Progression-Free Survival (PFS) [Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases]
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
- Overall Survival [Date of randomization until date of death or date of last follow-up assessment]
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
adult patients, >=18 years of age;
-
histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
-
measurable disease;
-
no previous chemotherapy for non-small cell lung cancer.
Exclusion Criteria:
-
unstable systemic disease;
-
any other malignancies in the last 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Campbelltown | Australia | 2560 | ||
| 2 | Camperdown | Australia | 2050 | ||
| 3 | Liverpool | Australia | 2170 | ||
| 4 | Guangzhou | China | 510060 | ||
| 5 | Guangzhou | China | 510080 | ||
| 6 | Shanghai | China | 200030 | ||
| 7 | Shanghai | China | 200433 | ||
| 8 | Hong Kong | Hong Kong | |||
| 9 | Jakarta | Indonesia | 10410 | ||
| 10 | Jakarta | Indonesia | 10430 | ||
| 11 | Jogjakarta | Indonesia | 55284 | ||
| 12 | Semarang | Indonesia | 50136 | ||
| 13 | Kyunggi-do | Korea, Republic of | 411-769 | ||
| 14 | Manila | Philippines | 1000 | ||
| 15 | Metro Manila | Philippines | 1502 | ||
| 16 | Taipei | Taiwan | 100 | ||
| 17 | Taipei | Taiwan | |||
| 18 | Bangkok | Thailand | 10400 | ||
| 19 | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Chair: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01998919
Other Study ID Numbers:
- MO18633
First Posted:
Dec 2, 2013
Last Update Posted:
Jan 13, 2015
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Period Title: Overall Study | ||
| STARTED | 79 | 74 |
| Randomized | 78 | 76 |
| COMPLETED | 37 | 39 |
| NOT COMPLETED | 42 | 35 |
Baseline Characteristics
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy | Total |
|---|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. | Total of all reporting groups |
| Overall Participants | 78 | 76 | 154 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.5
(10.06)
|
56.4
(10.43)
|
56.45
(10.245)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
30.8%
|
22
28.9%
|
46
29.9%
|
| Male |
54
69.2%
|
54
71.1%
|
108
70.1%
|
Outcome Measures
| Title | Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) |
|---|---|
| Description | Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started. |
| Time Frame | Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received. |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Number (95% Confidence Interval) [percentage of participants] |
76.9
98.6%
|
80.3
105.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.34 | |
| Confidence Interval |
(2-Sided) 95% -10.3 to 17.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Approximate 95% CI for difference of two rates using Hauck-Anderson method. | |
| Title | Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST |
|---|---|
| Description | Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Number (95% Confidence Interval) [percentage of participants] |
53.8
69%
|
64.5
84.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.63 | |
| Confidence Interval |
(2-Sided) 95% -5.6 to 26.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Approximate 95% CI for difference of two rates using Hauck-Anderson method. | |
| Title | Percentage of Participants With Confirmed CR or PR as Assessed by RECIST |
|---|---|
| Description | CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. |
| Time Frame | Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Number (95% Confidence Interval) [percentage of participants] |
24.4
31.3%
|
36.8
48.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 12.48 | |
| Confidence Interval |
(2-Sided) 95% -2.7 to 27.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Approximate 95% CI for difference of two rates using Hauck-Anderson method. | |
| Title | Duration of Response |
|---|---|
| Description | Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death. |
| Time Frame | Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR or PR were included in the analysis. |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 19 | 28 |
| Median (95% Confidence Interval) [weeks] |
24.1
|
38.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0075 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0099 |
| Comments | ||
| Method | Wald test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.42 | |
| Confidence Interval |
(2-Sided) 95% 0.22 to 0.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Progression |
|---|---|
| Description | Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization. |
| Time Frame | Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS Population |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Median (95% Confidence Interval) [weeks] |
24.1
|
31.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Wald Test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.48 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first. |
| Time Frame | Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS Population |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Median (95% Confidence Interval) [weeks] |
23.4
|
30.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wald test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.47 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 0.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Survival |
|---|---|
| Description | Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. |
| Time Frame | Date of randomization until date of death or date of last follow-up assessment |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS Population |
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy |
|---|---|---|
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. |
| Measure Participants | 78 | 76 |
| Median (95% Confidence Interval) [weeks] |
75.7
|
74.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5991 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo Plus Chemotherapy, Erlotinib Plus Chemotherapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3774 |
| Comments | ||
| Method | Wald test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment. | |||
| Arm/Group Title | Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy | ||
| Arm/Group Description | Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily. | Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily. | ||
All Cause Mortality |
||||
| Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/79 (21.5%) | 17/74 (23%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 5/79 (6.3%) | 5/74 (6.8%) | ||
| Febrile neutropenia | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Thrombocytopenia | 2/79 (2.5%) | 0/74 (0%) | ||
| Bone marrow failure | 1/79 (1.3%) | 0/74 (0%) | ||
| Cardiac disorders | ||||
| Myocardial infarction | 0/79 (0%) | 1/74 (1.4%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Vomiting | 2/79 (2.5%) | 0/74 (0%) | ||
| Constipation | 1/79 (1.3%) | 0/74 (0%) | ||
| Upper gastrointestinal haemorrhage | 1/79 (1.3%) | 0/74 (0%) | ||
| General disorders | ||||
| Fatigue | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Pain | 1/79 (1.3%) | 0/74 (0%) | ||
| Pyrexia | 1/79 (1.3%) | 0/74 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic function abnormal | 0/79 (0%) | 1/74 (1.4%) | ||
| Infections and infestations | ||||
| Pneumonia | 0/79 (0%) | 2/74 (2.7%) | ||
| Diverticulitis | 1/79 (1.3%) | 0/74 (0%) | ||
| Infection | 1/79 (1.3%) | 0/74 (0%) | ||
| Lower Respiratory Tract Infection | 0/79 (0%) | 1/74 (1.4%) | ||
| Lymphangitis | 0/79 (0%) | 1/74 (1.4%) | ||
| Pyelonephritis acute | 0/79 (0%) | 1/74 (1.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Femur fracture | 1/79 (1.3%) | 0/74 (0%) | ||
| Forearm fracture | 0/79 (0%) | 1/74 (1.4%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus inadequate control | 0/79 (0%) | 1/74 (1.4%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Cerebral infarction | 1/79 (1.3%) | 0/74 (0%) | ||
| Haemorrhage intracranial | 0/79 (0%) | 1/74 (1.4%) | ||
| Renal and urinary disorders | ||||
| Renal Impairment | 0/79 (0%) | 1/74 (1.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 3/79 (3.8%) | 1/74 (1.4%) | ||
| Haemoptysis | 1/79 (1.3%) | 0/74 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo Plus Chemotherapy | Erlotinib Plus Chemotherapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 74/79 (93.7%) | 73/74 (98.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 12/79 (15.2%) | 19/74 (25.7%) | ||
| Neutropenia | 17/79 (21.5%) | 17/74 (23%) | ||
| Thrombocytopenia | 6/79 (7.6%) | 6/74 (8.1%) | ||
| Leukopenia | 4/79 (5.1%) | 4/74 (5.4%) | ||
| Lymph node pain | 0/79 (0%) | 1/74 (1.4%) | ||
| Lymphadenopathy | 0/79 (0%) | 1/74 (1.4%) | ||
| Cardiac disorders | ||||
| Palpitations | 1/79 (1.3%) | 2/74 (2.7%) | ||
| Angina pectoris | 0/79 (0%) | 1/74 (1.4%) | ||
| Arrhythmia | 1/79 (1.3%) | 0/74 (0%) | ||
| Tachycardia | 1/79 (1.3%) | 0/74 (0%) | ||
| Ear and labyrinth disorders | ||||
| Tinnitus | 4/79 (5.1%) | 1/74 (1.4%) | ||
| Deafness | 0/79 (0%) | 1/74 (1.4%) | ||
| Ear disorder | 0/79 (0%) | 1/74 (1.4%) | ||
| Hypoacusis | 1/79 (1.3%) | 0/74 (0%) | ||
| Vertigo | 0/79 (0%) | 1/74 (1.4%) | ||
| Eye disorders | ||||
| Dry eye | 1/79 (1.3%) | 3/74 (4.1%) | ||
| Vision blurred | 2/79 (2.5%) | 1/74 (1.4%) | ||
| Conjunctivitis | 0/79 (0%) | 2/74 (2.7%) | ||
| Abnormal sensation in eye | 1/79 (1.3%) | 0/74 (0%) | ||
| Conjunctivitis allergic | 0/79 (0%) | 1/74 (1.4%) | ||
| Eye pain | 0/79 (0%) | 1/74 (1.4%) | ||
| Eye pruritus | 1/79 (1.3%) | 0/74 (0%) | ||
| Eyelid oedema | 0/79 (0%) | 1/74 (1.4%) | ||
| Lacrimation increased | 1/79 (1.3%) | 0/74 (0%) | ||
| Meibomian gland dysfunction | 0/79 (0%) | 1/74 (1.4%) | ||
| Visual impairment | 0/79 (0%) | 1/74 (1.4%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 37/79 (46.8%) | 34/74 (45.9%) | ||
| Vomiting | 29/79 (36.7%) | 22/74 (29.7%) | ||
| Constipation | 25/79 (31.6%) | 22/74 (29.7%) | ||
| Diarrhoea | 20/79 (25.3%) | 26/74 (35.1%) | ||
| Stomatitis | 3/79 (3.8%) | 9/74 (12.2%) | ||
| Abdominal pain upper | 4/79 (5.1%) | 5/74 (6.8%) | ||
| Abdominal pain | 3/79 (3.8%) | 5/74 (6.8%) | ||
| Mouth ulceration | 0/79 (0%) | 6/74 (8.1%) | ||
| Abdominal distension | 4/79 (5.1%) | 3/74 (4.1%) | ||
| Dry mouth | 4/79 (5.1%) | 1/74 (1.4%) | ||
| Toothache | 3/79 (3.8%) | 3/74 (4.1%) | ||
| Dysphagia | 2/79 (2.5%) | 2/74 (2.7%) | ||
| Dyspepsia | 1/79 (1.3%) | 2/74 (2.7%) | ||
| Gastritis | 0/79 (0%) | 3/74 (4.1%) | ||
| Glossitis | 0/79 (0%) | 2/74 (2.7%) | ||
| Abdominal discomfort | 1/79 (1.3%) | 0/74 (0%) | ||
| Epigastric discomfort | 1/79 (1.3%) | 0/74 (0%) | ||
| Gastrointestinal haemorrhage | 1/79 (1.3%) | 0/74 (0%) | ||
| Gastrointestinal pain | 0/79 (0%) | 1/74 (1.4%) | ||
| Gastrooesophageal reflux disease | 1/79 (1.3%) | 0/74 (0%) | ||
| Haematochezia | 0/79 (0%) | 1/74 (1.4%) | ||
| Haemorrhoidal haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| Haemorrhoids | 0/79 (0%) | 1/74 (1.4%) | ||
| Ileus | 1/79 (1.3%) | 0/74 (0%) | ||
| Lip ulceration | 1/79 (1.3%) | 0/74 (0%) | ||
| Oesophageal pain | 0/79 (0%) | 1/74 (1.4%) | ||
| Parotid gland enlargement | 1/79 (1.3%) | 0/74 (0%) | ||
| Periodontal disease | 0/79 (0%) | 1/74 (1.4%) | ||
| Rectal haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| Tongue ulceration | 0/79 (0%) | 1/74 (1.4%) | ||
| Tooth socket haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| General disorders | ||||
| Fatigue | 18/79 (22.8%) | 23/74 (31.1%) | ||
| Pyrexia | 11/79 (13.9%) | 10/74 (13.5%) | ||
| Chest pain | 10/79 (12.7%) | 5/74 (6.8%) | ||
| Asthenia | 5/79 (6.3%) | 5/74 (6.8%) | ||
| Mucosal inflammation | 1/79 (1.3%) | 6/74 (8.1%) | ||
| Malaise | 7/79 (8.9%) | 2/74 (2.7%) | ||
| Chest discomfort | 2/79 (2.5%) | 3/74 (4.1%) | ||
| Pain | 3/79 (3.8%) | 2/74 (2.7%) | ||
| Chills | 2/79 (2.5%) | 2/74 (2.7%) | ||
| Influenza like illness | 2/79 (2.5%) | 2/74 (2.7%) | ||
| Oedema peripheral | 1/79 (1.3%) | 2/74 (2.7%) | ||
| Oedema | 2/79 (2.5%) | 0/74 (0%) | ||
| Catheter site swelling | 0/79 (0%) | 1/74 (1.4%) | ||
| Discomfort | 0/79 (0%) | 1/74 (1.4%) | ||
| Face oedema | 1/79 (1.3%) | 0/74 (0%) | ||
| Gait disturbance | 0/79 (0%) | 1/74 (1.4%) | ||
| Local swelling | 1/79 (1.3%) | 0/74 (0%) | ||
| Hepatobiliary disorders | ||||
| Hyperbilirubinaemia | 2/79 (2.5%) | 4/74 (5.4%) | ||
| Hepatic function abnormal | 1/79 (1.3%) | 0/74 (0%) | ||
| Hepatic lesion | 1/79 (1.3%) | 0/74 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/79 (1.3%) | 0/74 (0%) | ||
| Infections and infestations | ||||
| Paronychia | 0/79 (0%) | 7/74 (9.5%) | ||
| Upper respiratory tract infection | 6/79 (7.6%) | 3/74 (4.1%) | ||
| Nasopharyngitis | 4/79 (5.1%) | 2/74 (2.7%) | ||
| Urinary tract infection | 3/79 (3.8%) | 1/74 (1.4%) | ||
| Pneumonia | 2/79 (2.5%) | 1/74 (1.4%) | ||
| Infection | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Nail infection | 0/79 (0%) | 2/74 (2.7%) | ||
| Oral herpes | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Abscess limb | 0/79 (0%) | 1/74 (1.4%) | ||
| Candidiasis | 1/79 (1.3%) | 0/74 (0%) | ||
| Cellulitis | 1/79 (1.3%) | 0/74 (0%) | ||
| Herpes virus infection | 0/79 (0%) | 1/74 (1.4%) | ||
| Laryngitis | 0/79 (0%) | 1/74 (1.4%) | ||
| Lower respiratory tract infection | 0/79 (0%) | 1/74 (1.4%) | ||
| Oral candidiasis | 0/79 (0%) | 1/74 (1.4%) | ||
| Pharyngitis | 0/79 (0%) | 1/74 (1.4%) | ||
| Sepsis | 1/79 (1.3%) | 0/74 (0%) | ||
| Tinea infection | 0/79 (0%) | 1/74 (1.4%) | ||
| Tinea versicolour | 1/79 (1.3%) | 0/74 (0%) | ||
| Tonsillitis | 0/79 (0%) | 1/74 (1.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 0/79 (0%) | 2/74 (2.7%) | ||
| Wound | 0/79 (0%) | 1/74 (1.4%) | ||
| Investigations | ||||
| Platelet count decreased | 5/79 (6.3%) | 7/74 (9.5%) | ||
| White blood cell count decreased | 7/79 (8.9%) | 5/74 (6.8%) | ||
| Neutrophil count decreased | 5/79 (6.3%) | 6/74 (8.1%) | ||
| Haemoglobin decreased | 4/79 (5.1%) | 6/74 (8.1%) | ||
| Alanine aminotransferase increased | 8/79 (10.1%) | 3/74 (4.1%) | ||
| White blood cell count | 6/79 (7.6%) | 2/74 (2.7%) | ||
| Aspartate aminotransferase increased | 5/79 (6.3%) | 2/74 (2.7%) | ||
| Neutrophil count | 4/79 (5.1%) | 1/74 (1.4%) | ||
| Blood creatinine increased | 2/79 (2.5%) | 1/74 (1.4%) | ||
| Platelet count | 2/79 (2.5%) | 1/74 (1.4%) | ||
| Blood sodium decreased | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Haemoglobin | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Hepatic enzyme increased | 2/79 (2.5%) | 0/74 (0%) | ||
| Weight decreased | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Weight increased | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Alanine aminotransferase | 1/79 (1.3%) | 0/74 (0%) | ||
| Aspartate aminotransferase | 1/79 (1.3%) | 0/74 (0%) | ||
| Blood albumin decreased | 0/79 (0%) | 1/74 (1.4%) | ||
| Blood bilirubin increased | 0/79 (0%) | 1/74 (1.4%) | ||
| Blood creatinine abnormal | 0/79 (0%) | 1/74 (1.4%) | ||
| Blood potassium decreased | 0/79 (0%) | 1/74 (1.4%) | ||
| Blood pressure increased | 1/79 (1.3%) | 0/74 (0%) | ||
| Creatinine renal clearance decreased | 1/79 (1.3%) | 0/74 (0%) | ||
| Liver function test abnormal | 0/79 (0%) | 1/74 (1.4%) | ||
| Neutrophil percentage decreased | 0/79 (0%) | 1/74 (1.4%) | ||
| Sputum abnormal | 0/79 (0%) | 1/74 (1.4%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 33/79 (41.8%) | 30/74 (40.5%) | ||
| Hypokalaemia | 3/79 (3.8%) | 1/74 (1.4%) | ||
| Hyponatraemia | 3/79 (3.8%) | 0/74 (0%) | ||
| Hyperglycaemia | 2/79 (2.5%) | 0/74 (0%) | ||
| Hypoalbuminaemia | 2/79 (2.5%) | 0/74 (0%) | ||
| Diabetes mellitus | 1/79 (1.3%) | 0/74 (0%) | ||
| Hyperkalaemia | 0/79 (0%) | 1/74 (1.4%) | ||
| Hyperuricaemia | 1/79 (1.3%) | 0/74 (0%) | ||
| Hypoproteinaemia | 1/79 (1.3%) | 0/74 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 6/79 (7.6%) | 7/74 (9.5%) | ||
| Back pain | 7/79 (8.9%) | 4/74 (5.4%) | ||
| Arthralgia | 4/79 (5.1%) | 4/74 (5.4%) | ||
| Bone pain | 6/79 (7.6%) | 1/74 (1.4%) | ||
| Musculoskeletal pain | 3/79 (3.8%) | 1/74 (1.4%) | ||
| Pain in extremity | 1/79 (1.3%) | 3/74 (4.1%) | ||
| Flank pain | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Musculoskeletal chest pain | 0/79 (0%) | 2/74 (2.7%) | ||
| Neck pain | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Muscle fatigue | 0/79 (0%) | 1/74 (1.4%) | ||
| Muscle spasms | 0/79 (0%) | 1/74 (1.4%) | ||
| Nervous system disorders | ||||
| Dizziness | 6/79 (7.6%) | 7/74 (9.5%) | ||
| Dysgeusia | 2/79 (2.5%) | 5/74 (6.8%) | ||
| Neuropathy peripheral | 1/79 (1.3%) | 4/74 (5.4%) | ||
| Headache | 9/79 (11.4%) | 3/74 (4.1%) | ||
| Peripheral sensory neuropathy | 4/79 (5.1%) | 2/74 (2.7%) | ||
| Hypoaesthesia | 3/79 (3.8%) | 1/74 (1.4%) | ||
| Somnolence | 2/79 (2.5%) | 0/74 (0%) | ||
| Cognitive disorder | 1/79 (1.3%) | 0/74 (0%) | ||
| Disturbance in attention | 0/79 (0%) | 1/74 (1.4%) | ||
| Paraesthesia | 1/79 (1.3%) | 0/74 (0%) | ||
| Psychiatric disorders | ||||
| Insomnia | 11/79 (13.9%) | 9/74 (12.2%) | ||
| Anxiety | 2/79 (2.5%) | 1/74 (1.4%) | ||
| Depression | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Delirium | 0/79 (0%) | 1/74 (1.4%) | ||
| Renal and urinary disorders | ||||
| Renal impairment | 4/79 (5.1%) | 3/74 (4.1%) | ||
| Dysuria | 1/79 (1.3%) | 0/74 (0%) | ||
| Proteinuria | 0/79 (0%) | 1/74 (1.4%) | ||
| Reproductive system and breast disorders | ||||
| Breast swelling | 0/79 (0%) | 1/74 (1.4%) | ||
| Menstruation irregular | 0/79 (0%) | 1/74 (1.4%) | ||
| Uterine haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 14/79 (17.7%) | 14/74 (18.9%) | ||
| Dyspnoea | 8/79 (10.1%) | 6/74 (8.1%) | ||
| Haemoptysis | 5/79 (6.3%) | 4/74 (5.4%) | ||
| Oropharyngeal pain | 2/79 (2.5%) | 6/74 (8.1%) | ||
| Productive cough | 3/79 (3.8%) | 5/74 (6.8%) | ||
| Epistaxis | 2/79 (2.5%) | 4/74 (5.4%) | ||
| Hiccups | 6/79 (7.6%) | 3/74 (4.1%) | ||
| Rhinorrhoea | 2/79 (2.5%) | 3/74 (4.1%) | ||
| Dysphonia | 1/79 (1.3%) | 3/74 (4.1%) | ||
| Sneezing | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Dyspnoea exertional | 0/79 (0%) | 1/74 (1.4%) | ||
| Nasal dryness | 1/79 (1.3%) | 0/74 (0%) | ||
| Pharyngeal ulceration | 0/79 (0%) | 1/74 (1.4%) | ||
| Pulmonary haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| Respiratory tract haemorrhage | 0/79 (0%) | 1/74 (1.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 19/79 (24.1%) | 20/74 (27%) | ||
| Dry skin | 7/79 (8.9%) | 17/74 (23%) | ||
| Pruritus | 6/79 (7.6%) | 10/74 (13.5%) | ||
| Rash | 32/79 (40.5%) | 48/74 (64.9%) | ||
| Acne | 2/79 (2.5%) | 8/74 (10.8%) | ||
| Dermatitis acneiform | 1/79 (1.3%) | 9/74 (12.2%) | ||
| Skin exfoliation | 1/79 (1.3%) | 3/74 (4.1%) | ||
| Rash papular | 1/79 (1.3%) | 2/74 (2.7%) | ||
| Hyperhidrosis | 1/79 (1.3%) | 1/74 (1.4%) | ||
| Nail disorder | 0/79 (0%) | 2/74 (2.7%) | ||
| Purpura | 2/79 (2.5%) | 0/74 (0%) | ||
| Rash pruritic | 2/79 (2.5%) | 0/74 (0%) | ||
| Decubitus ulcer | 1/79 (1.3%) | 0/74 (0%) | ||
| Dermatitis | 0/79 (0%) | 1/74 (1.4%) | ||
| Dermatitis allergic | 1/79 (1.3%) | 0/74 (0%) | ||
| Dyshidrosis | 0/79 (0%) | 1/74 (1.4%) | ||
| Eczema | 0/79 (0%) | 1/74 (1.4%) | ||
| Pruritus generalised | 0/79 (0%) | 1/74 (1.4%) | ||
| Rash erythematous | 0/79 (0%) | 1/74 (1.4%) | ||
| Rash maculo-papular | 0/79 (0%) | 1/74 (1.4%) | ||
| Seborrhoeic dermatitis | 1/79 (1.3%) | 0/74 (0%) | ||
| Skin discolouration | 1/79 (1.3%) | 0/74 (0%) | ||
| Skin hyperpigmentation | 0/79 (0%) | 1/74 (1.4%) | ||
| Skin ulcer | 0/79 (0%) | 1/74 (1.4%) | ||
| Vascular disorders | ||||
| Hypertension | 4/79 (5.1%) | 3/74 (4.1%) | ||
| Hypotension | 2/79 (2.5%) | 0/74 (0%) | ||
| Flushing | 1/79 (1.3%) | 0/74 (0%) | ||
| Hot flush | 0/79 (0%) | 1/74 (1.4%) | ||
| Thrombosis | 0/79 (0%) | 1/74 (1.4%) | ||
| Vasculitis | 1/79 (1.3%) | 0/74 (0%) | ||
| Vein pain | 1/79 (1.3%) | 0/74 (0%) | ||
| Venous thrombosis limb | 1/79 (1.3%) | 0/74 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann- LaRoche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01998919
Other Study ID Numbers:
- MO18633
First Posted:
Dec 2, 2013
Last Update Posted:
Jan 13, 2015
Last Verified:
Dec 1, 2014