Trial Outcomes & Findings for Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma (NCT NCT01032070)

NCT ID: NCT01032070

Last Updated: 2024-12-12

Results Overview

Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks. CR: • Complete disappearance of all enhancing tumor and mass effect • On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses) • Stable or improving neurologic examination sustained for ≥ 4 weeks • If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings). PR: • ≥ 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
• Results posted on: 2024-12-12

Participant Flow

Participant milestones

Measure	Erlotinib Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Overall Study STARTED	13	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Measure	Erlotinib Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Overall Study Disease progression	13	8
Overall Study Medical or ethical reasons	0	2
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

Baseline characteristics by cohort

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Total n=25 Participants Total of all reporting groups
Age, Continuous	12.8 years STANDARD_DEVIATION 5.87 • n=5 Participants	9.2 years STANDARD_DEVIATION 4.99 • n=7 Participants	11.1 years STANDARD_DEVIATION 5.67 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Indian Subcontinent	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian - Southeast Asia	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Body Surface Area (BSA)	1.51 m^2 STANDARD_DEVIATION 0.556 • n=5 Participants	1.17 m^2 STANDARD_DEVIATION 0.439 • n=7 Participants	1.35 m^2 STANDARD_DEVIATION 0.521 • n=5 Participants
Tumor Type for Initial Disease Diagnosis Anaplastic Ependymoma	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Tumor Type for Initial Disease Diagnosis Ependymoma	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Tumor Type for Initial Disease Diagnosis Myxopapillary Ependymoma	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Total Number of Disease Recurrences	3 recurrences FULL_RANGE 2.1 • n=5 Participants	2 recurrences FULL_RANGE 0.8 • n=7 Participants	2 recurrences FULL_RANGE 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization.

Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks. CR: • Complete disappearance of all enhancing tumor and mass effect • On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses) • Stable or improving neurologic examination sustained for ≥ 4 weeks • If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings). PR: • ≥ 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Percentage of Participants With an Objective Response	0 percentage of participants Interval 0.0 to 24.7	16.7 percentage of participants Interval 2.1 to 48.4

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: Full Analysis Set participants whose best overall response was CR or PR.

Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.

Outcome measures

Measure	Erlotinib Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=2 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Duration of Response	—	NA days Two participants achieving PR were censored at 174 and 463 days, respectively.

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: The Full Analysis Set

Participants with a best overall response of minor response (MR), defined as: • ≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Percentage of Participants With a Minor Response	0 percentage of participants Interval 0.0 to 24.7	25.0 percentage of participants Interval 5.5 to 57.2

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: The Full Analysis Set

Disease control is a best overall response of CR or PR or MR or Stable disease (SD). CR: • Complete disappearance of all enhancing tumor and mass effect • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks • If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively). PR: • ≥ 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks. MR: • ≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks. SD: • Neurologic examination is at least stable • Maintenance corticosteroid dose is not increased • MRI meets neither the criteria for minor response nor for progressive disease • Sustained for ≥ 8 weeks.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Percentage of Participants With Disease Control	15.4 percentage of participants Interval 1.9 to 45.4	41.7 percentage of participants Interval 15.2 to 72.3

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: The Full Analysis Set

Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first. Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Progression Free Survival (PFS)	52 days Interval 29.0 to 62.0	65 days Interval 23.0 to Upper limit could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: The Full Analysis Set

Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Percentage of Participants With Prolonged Stable Disease	0 percentage of participants Interval 0.0 to 24.7	41.7 percentage of participants Interval 15.2 to 72.3

SECONDARY outcome

Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: Full Analysis Set participants whose best overall response was CR, PR, MR or SD.

Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.

Outcome measures

Measure	Erlotinib n=2 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=5 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Duration of Stable Disease	79 days Interval 78.0 to 80.0	NA days Interval 117.0 to Not calculable due to the low number of events (disease progression or death)

SECONDARY outcome

Timeframe: From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.

Population: The Full Analysis Set

Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Overall Survival (OS)	NA days Interval 114.0 to Could not be estimated due to the low number of events.	261 days Interval 154.0 to Could not be estimated due to the low number of events.

SECONDARY outcome

Timeframe: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Population: All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set).

An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs. An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related.

Outcome measures

Measure	Erlotinib n=13 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 Participants Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Any adverse event	13 participants	11 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Drug-related adverse event	11 participants	10 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Adverse event leading to death	1 participants	0 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Drug-related adverse event leading to death	0 participants	0 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Serious adverse event	6 participants	5 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Drug-related serious adverse event	0 participants	1 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) AE leading to discontinuation	0 participants	0 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Drug-related AE leading to discontinuation	0 participants	0 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) AE leading to dose interruption	2 participants	5 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Drug-related AE leading to dose interruption	1 participants	3 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) AE leading to dose interruption and reduction	1 participants	2 participants
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) Related AE leading to dose interruption/ reduction	1 participants	2 participants

SECONDARY outcome

Timeframe: Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.

Population: The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation.

Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.

Outcome measures

Measure	Erlotinib n=11 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib	26716.7 h*ng/mL Interval 20269.0 to 35215.4	—

SECONDARY outcome

Timeframe: Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.

Population: The Pharmacokinetics Analysis Set

Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.

Outcome measures

Measure	Erlotinib n=11 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Maximum Observed Plasma Concentration of Erlotinib (Cmax)	1969.5 ng/mL Interval 1627.7 to 2382.9	—

SECONDARY outcome

Timeframe: Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.

Population: The Pharmacokinetics Analysis Set

Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.

Outcome measures

Measure	Erlotinib n=11 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)	2.100 hours Interval 1.6 to 2.7	—

SECONDARY outcome

Timeframe: Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.

Population: The Pharmacokinetics Analysis Set

Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.

Outcome measures

Measure	Erlotinib n=11 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Apparent Body Clearance (CL/F) of Erlotinib	2922.1 mL/h/m^2 Interval 2233.4 to 3823.3	—

SECONDARY outcome

Timeframe: Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.

Population: The Pharmacokinetics Analysis Set

Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.

Outcome measures

Measure	Erlotinib n=11 Participants Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Apparent Volume of Distribution (Vz/F) of Erlotinib	71628.5 mL/m^2 Interval 59572.0 to 86124.9	—

Adverse Events

Erlotinib

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Etoposide

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib n=13 participants at risk Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 participants at risk Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Nervous system disorders Convulsion	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Hydrocephalus	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Grand mal convulsion	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Headache	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Hemiparesis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Loss of consciousness	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Gastritis haemorrhagic	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Pyrexia	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Viral upper respiratory tract infection	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Lung infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Confusional state	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Weight decreased	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Renal and urinary disorders Pollakiuria	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Renal and urinary disorders Urinary hesitation	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Other adverse events

Measure	Erlotinib n=13 participants at risk Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.	Etoposide n=12 participants at risk Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Skin and subcutaneous tissue disorders Hypoaethesia facial	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Gastrointestinal haemorrhage	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Mouth ulceration	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Lip ulceration	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Retching	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Rash	30.8% 4/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Dermatitis acneiform	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Pruritus	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Erythema	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Rash maculo-papular	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Purpura	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Rash macular	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Skin fissures	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Skin ulcer	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Acne	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Diarrhoea	46.2% 6/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Vomiting	46.2% 6/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	66.7% 8/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Constipation	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	50.0% 6/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Nausea	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	41.7% 5/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Stomatitis	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Gastrointestinal disorders Gastritis	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Skin striae	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Headache	38.5% 5/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	58.3% 7/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Nystagmus	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Ataxia	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Peripheral sensory neuropathy	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Cerebellar syndrome	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Dizziness	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Facial palsy	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Hypoaethesia	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Loss of consciousness	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Meningism	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Nervous system disorder	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Somnolence	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Ageusia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Amnesia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Coordination abnormal	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Cranial nerve disorder	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Hypersomnia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Muscle spasticity	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders Tongue paralysis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Upper motor neurone lesion	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders VIIth nerve paralysis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Nervous system disorders VIth nerve paralysis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Fatigue	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	66.7% 8/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Oedema peripheral	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Pain	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Pyrexia	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Mucosal inflammation	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Chills	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Irritability	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
General disorders Malaise	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Muscular weakness	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Weight decreased	23.1% 3/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Neutrophil count decreased	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Platelet count decreased	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Blood pressure increased	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Blood urine present	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Heart rate increased	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Urine output decreased	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Investigations Weight increased	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	33.3% 4/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	25.0% 3/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	25.0% 3/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Eye disorders Diplopia	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Eye disorders Eye movement disorder	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Eye disorders Vision blurred	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Eye disorders Optic nerve disorder	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Eye disorders Strabismus	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Escherichia urinary tract infection	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Otitis media	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Paronychia	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Bronchitis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Conjunctivitis infective	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Corneal infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Fungal skin infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Mucosal infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Nasopharyngitis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Pneumonia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Sinusitis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	25.0% 3/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Infections and infestations urinary tract infection	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Contusion	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Procedural pain	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Anthropod bite	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Catheter site pain	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Head injury	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Decreased appetite	15.4% 2/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Ear and labyrinth disorders Ear pain	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Ear and labyrinth disorders Tympanic membrane perforation	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Ear and labyrinth disorders Tinnitus	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Vascular disorders Hypotension	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Vascular disorders Vena cava thrombosis	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Vascular disorders Epistaxis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Vascular disorders Hypertension	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Immune system disorders Multiple allergies	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Confusional state	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	0.00% 0/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Agitation	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Depressed mood	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Depression	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Psychiatric disorders Insomnia	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	25.0% 3/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Renal and urinary disorders Urinary incontinence	7.7% 1/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Renal and urinary disorders Bladder spasm	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Renal and urinary disorders Enuresis	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Endocrine disorders Cushingoid	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	16.7% 2/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Reproductive system and breast disorders Breast enlargement	0.00% 0/13 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	8.3% 1/12 • From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.

Additional Information

Senior Medical Director, Medical Oncology

Astellas Pharma Global Development, Inc

Email: ClinicalTrials.Disclosure@us.astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
• Publication restrictions are in place

Restriction type: OTHER