Trial Outcomes & Findings for Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC (NCT NCT00294762)
NCT ID: NCT00294762
Last Updated: 2012-08-09
Results Overview
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
6 months after first dose
Results posted on
2012-08-09
Participant Flow
The first patient was treated 28 March 2006 and the analysis database locked 20 March 2009
All enrolled patients were randomly assigned to 1 of 2 treatment groups.
Participant milestones
| Measure |
Erlotinib
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
69
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Erlotinib
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Overall Study
Did not receive study treatment
|
3
|
3
|
Baseline Characteristics
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
Baseline characteristics by cohort
| Measure |
Erlotinib
n=72 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=71 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after first dosePopulation: All patients who received at least one dose of study drug.
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Outcome measures
| Measure |
Erlotinib
n=69 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
6-month Progression-free Survival
|
30.7 Percentage of Patients
Interval 20.2 to 41.9
|
26.4 Percentage of Patients
Interval 15.9 to 38.0
|
SECONDARY outcome
Timeframe: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)Population: All patients who received at least 1 dose of study drug
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Outcome measures
| Measure |
Erlotinib
n=69 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Progression-free Survival
|
2.69 months
Interval 0.03 to 28.85
|
4.57 months
Interval 0.03 to 24.51
|
SECONDARY outcome
Timeframe: 12 months from 1st dosePopulation: All patients who received at least 1 dose of study drug
Percentage of patients alive after 12 months of study treatment
Outcome measures
| Measure |
Erlotinib
n=69 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Overall Survival at 12 Months
|
58.6 Percent of Patients
Interval 45.6 to 69.5
|
46.4 Percent of Patients
Interval 33.3 to 58.6
|
SECONDARY outcome
Timeframe: From first study treatment until time of death (maximum 29.0 months)Population: All patients who received at least 1 dose of study drug
Median number of months from first study treatment until time of death
Outcome measures
| Measure |
Erlotinib
n=69 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Overall Survival
|
16.72 Months
Interval 0.26 to 29.01
|
11.43 Months
Interval 0.49 to 29.04
|
SECONDARY outcome
Timeframe: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)Population: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Outcome measures
| Measure |
Erlotinib
n=69 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=67 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Best Tumor Response
Complete Response (CR)
|
0 Percent of Patients
|
0 Percent of Patients
|
|
Best Tumor Response
Partial Response (PR)
|
11.6 Percent of Patients
|
22.4 Percent of Patients
|
|
Best Tumor Response
Stable Disease (SD)
|
34.8 Percent of Patients
|
49.3 Percent of Patients
|
|
Best Tumor Response
Progressive Disease (PD)
|
46.4 Percent of Patients
|
17.9 Percent of Patients
|
|
Best Tumor Response
Unable to Determine/Not Evaluable
|
7.2 Percent of Patients
|
10.4 Percent of Patients
|
SECONDARY outcome
Timeframe: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).Population: All patients who had any type of tumor response, ie, CR, PR, or SD
Median length of time that tumor showed any type of response, ie, CR, PR, or SD
Outcome measures
| Measure |
Erlotinib
n=32 Participants
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=48 Participants
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Duration of Tumor Response
|
6.4 Months
Interval 1.2 to 26.1
|
4.1 Months
Interval 1.0 to 23.1
|
Adverse Events
Erlotinib
Serious events: 27 serious events
Other events: 67 other events
Deaths: 0 deaths
Erlotinib + Chemotherapy (Intercalated)
Serious events: 27 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=69 participants at risk
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 participants at risk
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxix
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Bacterial infection
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Bronchitis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Meningitis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Sepsis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Wound infection
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Cardiac tamponade
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Transient ischaemic attack
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Arterial thrombosis
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Haematoma
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Phlebitis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Thrombophlebitis superfical
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Thrombosis
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
7.4%
5/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Convulsion
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Spinal chord compression
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Pyrexia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Heparin-induced thrombocytopenia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Oedema peripheral
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Confusional state
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
0.00%
0/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Investigations
Liver function test abnormal
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
Other adverse events
| Measure |
Erlotinib
n=69 participants at risk
150 mg erlotinib daily
|
Erlotinib + Chemotherapy (Intercalated)
n=68 participants at risk
carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
RASH
|
81.2%
56/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
76.5%
52/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.0%
40/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
50.0%
34/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
13/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
47.1%
32/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.9%
22/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
25.0%
17/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.5%
10/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
20.6%
14/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
13/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
16.2%
11/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.0%
9/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
7.4%
5/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
52.2%
36/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
63.2%
43/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
36.2%
25/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
61.8%
42/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
18.8%
13/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
33.8%
23/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
15.9%
11/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
36.8%
25/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dysgeusia
|
11.6%
8/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
19.1%
13/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
13.0%
9/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
9/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
11.8%
8/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
6/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Fatigue
|
40.6%
28/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
60.3%
41/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Pyrexia
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Oedema peripheral
|
14.5%
10/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Asthenia
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
13.2%
9/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Chills
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Pain
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Feeling cold
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Chest discomfort
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Influenza like illness
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
General disorders
Mucosal inflammation
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
7.4%
5/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Anorexia
|
30.4%
21/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
45.6%
31/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
23.5%
16/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
6/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
10.3%
7/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.2%
16/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
25.0%
17/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
15/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
23.5%
16/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
16.2%
11/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
15/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
10.3%
7/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
7/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
16.2%
11/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.1%
7/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Investigations
Weight decreased
|
21.7%
15/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
51.5%
35/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Investigations
Breath sounds abnormal
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Neuropathy peripheral
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
22.1%
15/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
16.2%
11/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
14.7%
10/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
8.7%
6/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Oral candidiasis
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
7.4%
5/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Rash pustular
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Infections and infestations
Paronychia
|
4.3%
3/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
2.9%
2/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Insomnia
|
14.5%
10/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
26.5%
18/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
10.1%
7/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
7.4%
5/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Anxiety
|
7.2%
5/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
8.8%
6/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
5.9%
4/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
26.5%
18/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
20.6%
14/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Eye disorders
Dry eye
|
5.8%
4/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Deep vein thrombosis
|
8.7%
6/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
1.5%
1/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
10.3%
7/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Vascular disorders
Hot flush
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Cardiac disorders
Tachycardia
|
2.9%
2/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
10.1%
7/69 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
4.4%
3/68 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60