Trial Outcomes & Findings for Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors (NCT NCT00095940)

Last Updated: 2014-05-23

Results Overview

Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

52 participants

Primary outcome timeframe

7-14 days after starting therapy and prior to surgery

Results posted on

2014-05-23

Participant Flow

Participants from institutions in the Pediatric Brain Tumor Consortium were enrolled between November 2006 and October 2008.

Participants with tumors for whom surgical resection was indicated enrolled on the molecular biology phase and randomized to 1) receive lapatinib for 7-14 days pre-surgery or 2) no lapatinib pre-surgery. Those in group 2 who had measurable disease post-surgery would be included in the phase II part as well, but no participant met this criteria.

Participant milestones

Participant milestones
Measure	Medulloblastoma: Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Medulloblastoma: No Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Medulloblastoma: No Surgery Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	High Grade Glioma: No Surgery Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	Ependymoma: Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Ependymoma: No Lapatnib Prior to Surgery Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Ependymoma: No Surgery Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
Molecular Biology Phase STARTED	2	2	0	0	2	2	0
Molecular Biology Phase COMPLETED	2	2	0	0	2	2	0
Molecular Biology Phase NOT COMPLETED	0	0	0	0	0	0	0
Lapatinib Continuation/Phase II STARTED	2	2	17	13	2	2	14
Lapatinib Continuation/Phase II COMPLETED	0	0	1	0	0	0	1
Lapatinib Continuation/Phase II NOT COMPLETED	2	2	16	13	2	2	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Medulloblastoma: Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Medulloblastoma: No Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Medulloblastoma: No Surgery Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	High Grade Glioma: No Surgery Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	Ependymoma: Lapatinib Prior to Surgery Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Ependymoma: No Lapatnib Prior to Surgery Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Ependymoma: No Surgery Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
Lapatinib Continuation/Phase II Disease Progression	1	1	15	13	2	1	12
Lapatinib Continuation/Phase II Withdrawal by Subject	1	1	1	0	0	0	1
Lapatinib Continuation/Phase II Adverse Event	0	0	0	0	0	1	0

Baseline Characteristics

Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medulloblastoma: Lapatinib Prior to Surgery n=2 Participants Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Medulloblastoma: No Lapatinib Prior to Surgery n=2 Participants Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Medulloblastoma: No Surgery n=17 Participants Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	High Grade Glioma: No Surgery n=13 Participants Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	Ependymoma: Lapatinib Prior to Surgery n=2 Participants Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.	Ependymoma: No Lapatnib Prior to Surgery n=2 Participants Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.	Ependymoma: No Surgery n=14 Participants Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	14 Participants n=8 Participants	45 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	7 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Continuous	11.6 years STANDARD_DEVIATION 12.0 • n=5 Participants	8.7 years STANDARD_DEVIATION .27 • n=7 Participants	14.2 years STANDARD_DEVIATION 5.9 • n=5 Participants	13.5 years STANDARD_DEVIATION 4.5 • n=4 Participants	7.1 years STANDARD_DEVIATION 1.8 • n=21 Participants	9.9 years STANDARD_DEVIATION 1.8 • n=8 Participants	8.0 years STANDARD_DEVIATION 4.1 • n=8 Participants	11.6 years STANDARD_DEVIATION 5.6 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants	26 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants	26 Participants n=24 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	17 participants n=5 Participants	13 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	14 participants n=8 Participants	52 participants n=24 Participants

PRIMARY outcome

Timeframe: 7-14 days after starting therapy and prior to surgery

Population: Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=4 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery n=3 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Relative Phosphorylation of ERBB2 (Molecular Biology Objective)	.21 ratio Interval 0.03 to 0.44	.50 ratio Interval 0.05 to 1.66	—

PRIMARY outcome

Timeframe: From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)

Population: Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.

A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=15 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery n=13 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma n=13 Participants Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of lapatinib prior to surgery

Population: The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.

For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=3 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)	18 percent Interval 11.0 to 22.0	—	—

SECONDARY outcome

Timeframe: First dose of lapatinib in course 1

Population: The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.

Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=13 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Maximum Concentration of Lapatinib in Plasma (Phase II Objective)	5050 nanogram/milliliter Interval 1915.0 to 10500.0	—	—

SECONDARY outcome

Timeframe: Pre-treatment

Population: Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.

Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=9 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery n=7 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma n=9 Participants Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Number of Participants With Tumors Expressing Total ERBB2	1 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: Pre-treatment

Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.

Outcome measures

Outcome measures
Measure	Lapatinib Prior to Surgery n=9 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	No Lapatinib Prior to Surgery n=7 Participants Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Recurrent Ependymoma n=9 Participants Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)	1 Participants	4 Participants	6 Participants

Adverse Events

Medulloblastoma: Lapatinib Prior to Surgery

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Medulloblastoma: No Lapatinib Prior to Surgery

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Medulloblastoma: No Surgery

Serious events: 9 serious events

Other events: 16 other events

Deaths: 0 deaths

High Grade Glioma: No Surgery

Serious events: 10 serious events

Other events: 13 other events

Deaths: 0 deaths

Ependymoma: Lapatinib Prior to Surgery

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Ependymoma: No Lapatnib Prior to Surgery

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Ependymoma: No Surgery

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medulloblastoma: Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	Medulloblastoma: No Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.	Medulloblastoma: No Surgery n=16 participants at risk Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.	High Grade Glioma: No Surgery n=13 participants at risk Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.	Ependymoma: Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	Ependymoma: No Lapatnib Prior to Surgery n=2 participants at risk Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Ependymoma: No Surgery n=14 participants at risk Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations AST,SGOT (serum glutamic oxaloacetic transaminase)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Ataxia (incoordination)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Bilirubin (hyperbilirubinemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
General disorders Fever (in the absence of neutropenia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Leak, cerebrospinal fluid	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Leukocytes	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Lymphopenia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Neutrophils/granulocytes	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Platelets	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Seizure	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Somnolence/depressed level of consciousness	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Speech impairment	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Tremor	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.

Other adverse events

Other adverse events
Measure	Medulloblastoma: Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	Medulloblastoma: No Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.	Medulloblastoma: No Surgery n=16 participants at risk Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.	High Grade Glioma: No Surgery n=13 participants at risk Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.	Ependymoma: Lapatinib Prior to Surgery n=2 participants at risk Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.	Ependymoma: No Lapatnib Prior to Surgery n=2 participants at risk Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.	Ependymoma: No Surgery n=14 participants at risk Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
Gastrointestinal disorders Incontinence, anal	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Renal and urinary disorders Incontinence, urinary	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	30.8% 4/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 7/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	30.8% 4/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	35.7% 5/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	28.6% 4/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Alkaline phosphatase	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Amylase	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Anorexia	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Ataxia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Bicarbonate, serum-low	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	28.6% 4/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Bilirubin (hyperbilirubinemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	28.6% 4/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Cholesterol, serum-high (hypercholesteremia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Psychiatric disorders Confusion	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	21.4% 3/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Creatinine	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Endocrine disorders Cushingoid appearance	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Renal and urinary disorders Cystitis	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	81.2% 13/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	53.8% 7/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	85.7% 12/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Dizziness	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Enteritis	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Musculoskeletal and connective tissue disorders Extremity-upper (function)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
General disorders Fever (in the absence of neutropenia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	35.7% 5/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Flatulence	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Vascular disorders Flushing	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations GGT (gamma-Glutamyl transpeptidase)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Gastritis	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	35.7% 5/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Hair loss/alopecia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Hydrocephalus	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
General disorders Irritability (children < 3 years of age)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Leak, cerebrospinal fluid	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Leukocytes	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	31.2% 5/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Lymphopenia	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	43.8% 7/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	38.5% 5/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Nail changes	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	35.7% 5/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Neutrophils/granulocytes	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Nystagmus	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Eye disorders Ophthalmoplegia/diplopia (double vision)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Psychiatric disorders Personality/behavioral	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	23.1% 3/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	42.9% 6/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Platelets	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	25.0% 4/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	38.5% 5/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	28.6% 4/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Renal and urinary disorders Proteinuria	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Pruritus/itching	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Rash/desquamation	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 7/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	18.8% 3/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Seizure	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	15.4% 2/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Somnolence/depressed level of consciousness	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Speech impairment	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Nervous system disorders Tremor	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Renal and urinary disorders Urinary frequency/urgency	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Renal and urinary disorders Urine color change	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Eye disorders Vision-photophobia	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	6.2% 1/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.1% 1/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	56.2% 9/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	30.8% 4/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 1/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	50.0% 7/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
Investigations Weight loss	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	100.0% 2/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	12.5% 2/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	7.7% 1/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
General disorders Extremity-lower (gait/walking)	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/16 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/13 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	0.00% 0/2 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.	14.3% 2/14 • Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected. One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.

Additional Information

Assistant Director Operations and Biostatistics Center

Pediatric Brain Tumor Consortium

Phone: 901-595-2617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60