Trial Outcomes & Findings for A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas (NCT NCT01118377)

Last Updated: 2014-02-06

Results Overview

Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Baseline to the end of the study (up to 20 weeks)

Results posted on

2014-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine + Radiation Therapy Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Overall Study STARTED	45
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine + Radiation Therapy Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Overall Study Did Not Receive Study Medication	1
Overall Study Death	38
Overall Study Failure to Return	3

Baseline Characteristics

A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Radiation Therapy n=44 Participants Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Age, Continuous	7.5 years STANDARD_DEVIATION 3.69 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the study (up to 20 weeks)

Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.

Outcome measures

Outcome measures
Measure	Capecitabine + Radiation Therapy n=44 Participants Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Progression-free Survival	4.9 Months Interval 4.5 to 6.0

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 20 weeks)

Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.

Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.

Outcome measures

Outcome measures
Measure	Capecitabine + Radiation Therapy n=44 Participants Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Overall Survival	10.3 Months Interval 7.7 to 12.9

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 20 weeks)

Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.

Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.

Outcome measures

Outcome measures
Measure	Capecitabine + Radiation Therapy n=44 Participants Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Percentage of Participants With a Tumor Response	2.3 Percentage of participants Interval 0.1 to 12.0

Adverse Events

Capecitabine + Radiation Therapy

Serious events: 23 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine + Radiation Therapy n=44 participants at risk Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Nervous system disorders Central nervous system necrosis	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Hydrocephalus	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Convulsion	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Neurological symptom	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Depressed level of consciousness	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Dysarthria	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Haemorrhage intracranial	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Headache	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Somnolence	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Disease progression	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Pyrexia	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Death	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Device malfunction	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Irritability	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Oedema peripheral	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Neutrophil count decreased	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations White blood cell count decreased	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Alanine aminotransferase increased	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Diarrhoea	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Dysphagia	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Enterocolitis	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Vomiting	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Dehydration	4.5% 2/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hyperglycaemia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypoalbuminaemia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypokalaemia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypovolaemia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Infections and infestations Clostridial infection	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Infections and infestations Enterocolitis infectious	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Infections and infestations Gastroenteritis	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Infections and infestations Nail infection	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Aspiration	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Blood and lymphatic system disorders Anaemia	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Injury, poisoning and procedural complications Wound dehiscence	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Renal and urinary disorders Nephrolithiasis	2.3% 1/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.

Other adverse events

Other adverse events
Measure	Capecitabine + Radiation Therapy n=44 participants at risk Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Investigations Alanine aminotransferase increased	75.0% 33/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Lymphocyte count decreased	72.7% 32/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations White blood cell count decreased	61.4% 27/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Platelet count decreased	56.8% 25/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Blood bilirubin increased	31.8% 14/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Neutrophil count decreased	31.8% 14/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Aspartate aminotransferase increased	25.0% 11/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Weight increased	25.0% 11/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Gamma-glutamyltransferase increased	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Haemoglobin	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Weight decreased	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Haemoglobin increased	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Investigations Neutrophil count	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypoalbuminaemia	47.7% 21/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypokalaemia	40.9% 18/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypocalcaemia	38.6% 17/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypermagnesaemia	36.4% 16/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hyponatraemia	36.4% 16/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hyperglycaemia	34.1% 15/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypophosphataemia	31.8% 14/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Decreased appetite	25.0% 11/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypercalcaemia	18.2% 8/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypernatraemia	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Metabolism and nutrition disorders Hypoglycaemia	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Vomiting	79.5% 35/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Nausea	34.1% 15/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Constipation	31.8% 14/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Abdominal pain	25.0% 11/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Diarrhoea	25.0% 11/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Stomatitis	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Gastrointestinal disorders Abdominal distension	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	36.4% 16/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Dermatitis acneiform	15.9% 7/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Dry skin	15.9% 7/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Skin exfoliation	15.9% 7/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Alopecia	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Pruritus	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Headache	45.5% 20/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Ataxia	20.5% 9/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Facial nerve disorder	20.5% 9/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders VIth nerve disorder	18.2% 8/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Hemiparesis	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Dysarthria	11.4% 5/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Somnolence	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Vagus nerve disorder	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Central nervous system necrosis	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Dizziness	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Nervous system disorders Tremor	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Blood and lymphatic system disorders Anaemia	36.4% 16/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Blood and lymphatic system disorders Lymphopenia	20.5% 9/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Blood and lymphatic system disorders Leukopenia	18.2% 8/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Fatigue	40.9% 18/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Pyrexia	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Irritability	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
General disorders Pain	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Musculoskeletal and connective tissue disorders Muscular weakness	20.5% 9/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Musculoskeletal and connective tissue disorders Pain in extremity	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Musculoskeletal and connective tissue disorders Back pain	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Endocrine disorders Cushingoid	31.8% 14/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Endocrine disorders Adrenal insufficiency	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Psychiatric disorders Anxiety	13.6% 6/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Psychiatric disorders Insomnia	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Infections and infestations Mucosal infection	18.2% 8/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Renal and urinary disorders Pollakiuria	9.1% 4/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Cardiac disorders Sinus tachycardia	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.
Eye disorders Extraocular muscle paresis	6.8% 3/44 • Adverse events were reported from Baseline up to 30 days after the last treatment (up to 24 weeks). Safety population: All enrolled participants who received at least 1 dose of capecitabine. One of the 45 participants did not receive treatment and was not included in the safety population.

Additional Information

Medical Communications

Hoffmann-La Roche

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Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER