Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) for Liver Mets (NCT NCT01360606)

Last Updated: 2024-10-10

Results Overview

MTD as determined by dose limiting toxicities (DLT), defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity per RTOG criteria. Only toxicities observed prior to 7 months after the last fraction of radiation were considered. The MTD is the highest dose level at which no more than 1 of 6 treated patients experiences a DLT.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

Up to 16 Months

Results posted on

2024-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT - 50 Gy Stereotactic Body Radiation Therapy: SBRT: Patients received 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
50 Gy STARTED	3	0
50 Gy COMPLETED	3	0
50 Gy NOT COMPLETED	0	0
60 Gy STARTED	0	6
60 Gy COMPLETED	0	6
60 Gy NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiation Therapy (SBRT) for Liver Mets

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 16 Months

Population: All patients that received study treatment.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Maximum Tolerated Dose (MTD)	60 Gy	—

PRIMARY outcome

Timeframe: Up to 16 Months

Population: All patients that received study treatment.

Dose limiting toxicity (DLT) will be defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity as defined by the Radiation Therapy Oncology Group (RTOG).

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 years and 4 months (study population)

Population: All patients treated per protocol and radiologically evaluable.

Proportion of treated patients with stable disease (SD), partial response (PR), or complete response (CR) in the target lesion(s) per Response Evaluation Criteria in Solid Tumors (RECIST) in the target lesion(s) at one-year post-treatment. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. All lymph nodes must be non-pathological in size (\<10mm short axis); PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	All Participants n=2 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Local Control Complete Response	1 Participants	1 Participants
Local Control Partial Response	0 Participants	3 Participants
Local Control Stable Disease	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 6 years and 4 months (study population)

Population: All patients treated per protocol and radiologically evaluable.

Proportion of patients who experience local partial response (PR), or complete response (CR) in the target lesion(s) per Response Evaluation Criteria in Solid Tumors (RECIST) at any point in the first year of follow-up. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis); PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	All Participants n=2 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Local Response Rate Complete Response	1 Participants	1 Participants
Local Response Rate Partial Response	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

Population: All treated patients that completed QoL surveys.

Health related quality of life associated with this SBRT will be assessed over time using the FACT-G assessment tool, a self-administered questionnaire that measures quality of life within the prior 7 days in patients being treated for cancer. The tool has 27 items with a 5-point Likert-type scale, (0 = Not at all to 5 = Very Much). Subscales include Physical Well-Being max score=28), Social/Family Well-Being (max score=28), Emotional Well-Being (max score=24), Functional Well-Being (max score=28). Total scores range from 0 to 108. Questions are phrased so that higher numbers indicate a better health state, with some items reverse-scored.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
FACT-G - Health Related Quality of Life (HRQL) Over Time Screening	90.3 score on a scale Standard Deviation 15.0	88.0 score on a scale Standard Deviation 16.3
FACT-G - Health Related Quality of Life (HRQL) Over Time Initial Rx Therapy	82.6 score on a scale Standard Deviation 35.9	82.5 score on a scale Standard Deviation 23.0
FACT-G - Health Related Quality of Life (HRQL) Over Time Post completion of RX Therapy	107.0 score on a scale	91.0 score on a scale Standard Deviation 14.7
FACT-G - Health Related Quality of Life (HRQL) Over Time 1-2 months post final Rx	69.0 score on a scale Standard Deviation 5.7	78.0 score on a scale Standard Deviation 20.9
FACT-G - Health Related Quality of Life (HRQL) Over Time 3-5 months post final Rx	86.5 score on a scale Standard Deviation 6.4	83.1 score on a scale Standard Deviation 17.4
FACT-G - Health Related Quality of Life (HRQL) Over Time 6-8 months post final Rx	87.0 score on a scale	85.1 score on a scale Standard Deviation 17.0
FACT-G - Health Related Quality of Life (HRQL) Over Time 9-11 months post final Rx	—	80.4 score on a scale Standard Deviation 21.7
FACT-G - Health Related Quality of Life (HRQL) Over Time 12-14 months post final Rx	—	84.7 score on a scale Standard Deviation 16.1
FACT-G - Health Related Quality of Life (HRQL) Over Time 15-17 months post final Rx	—	71.0 score on a scale
FACT-G - Health Related Quality of Life (HRQL) Over Time 18-20 months post final Rx	78.0 score on a scale Standard Deviation 0.0	74.5 score on a scale Standard Deviation 17.7
FACT-G - Health Related Quality of Life (HRQL) Over Time 21-23 months post final Rx	—	69.0 score on a scale Standard Deviation 9.9
FACT-G - Health Related Quality of Life (HRQL) Over Time 24-26 months post final Rx	—	69.0 score on a scale

SECONDARY outcome

Timeframe: 1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

Population: All patients on study that completed QoL surveys

Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) subscale was used to assess health-related quality of life associated with SBRT. The FACT-Hep is part of the Functional Assessment of Chronic Illness Therapy (FACIT; 13) measurement system and includes the FACT-General (FACT-G) and an 8-item module specifically designed for patients diagnosed with hepatobiliary carcinomas. FACT-Hep questions are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much), with overall scores ranging from 0-32. Questions are phrased so that higher numbers indicate a better health state, with some items reverse-scored.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time Screening	27.0 score on a scale Standard Deviation 5.0	27.2 score on a scale Standard Deviation 4.6
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time Initial Rx Therapy	29.5 score on a scale Standard Deviation 3.5	24.5 score on a scale Standard Deviation 8.2
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time Post completion of RX Therapy	31.0 score on a scale	25.3 score on a scale Standard Deviation 5.8
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 1-2 months post final Rx	24.5 score on a scale Standard Deviation 2.1	21.2 score on a scale Standard Deviation 7.7
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 3-5 months post final Rx	25.0 score on a scale Standard Deviation 0.0	24.3 score on a scale Standard Deviation 5.8
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 6-8 months post final Rx	29.0 score on a scale	26.7 score on a scale Standard Deviation 4.6
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 9-11 months post final Rx	—	24.2 score on a scale Standard Deviation 5.7
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 12-14 months post final Rx	—	24.2 score on a scale Standard Deviation 4.6
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 15-17 months post final Rx	—	18.0 score on a scale
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 18-20 months post final Rx	23.0 score on a scale	22.0 score on a scale Standard Deviation 4.2
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 21-23 months post final Rx	—	22.5 score on a scale Standard Deviation 0.7
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time 24-26 months post final Rx	—	21.0 score on a scale

SECONDARY outcome

Timeframe: 1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

Population: All patients on study that completed QoL surveys

Trial Outcome Index (TOI), the sum of the physical and functional well-being subscales and the additional concerns subscale is calculated. The TOI is a commonly used endpoint in clinical trials because it is responsive to change, whereas the social/family and emotional well-being subscale scores do not change as quickly over time or have as great of change subsequent to pharmacological treatment. The FACT-Hep is part of the Functional Assessment of Chronic Illness Therapy (FACIT 13) measurement system and includes the FACT-General (FACT-G) and an 18-item module specifically designed for patients diagnosed with hepatobiliary carcinomas with domain scores ranging from 0-32. FACT-Hep questions are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total Index scores range from 0 to 128. Higher scores are associated with better QoL or fewer symptoms.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Stereotactic Body Radiation Therapy (SBRT) Patients that received at least one dose of either 50 Gy or 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
FACT-Hep-Trial Outcome Index (TOI) Screening	108.3 score on a scale Standard Deviation 13.7	106.0 score on a scale Standard Deviation 17.6
FACT-Hep-Trial Outcome Index (TOI) Initial Rx therapy session	107.0 score on a scale Standard Deviation 25.5	98.5 score on a scale Standard Deviation 29.0
FACT-Hep-Trial Outcome Index (TOI) After completion of final Rx	126.0 score on a scale	104.0 score on a scale Standard Deviation 21.4
FACT-Hep-Trial Outcome Index (TOI) 01-02 months post final Rx	92.5 score on a scale Standard Deviation 10.6	90.4 score on a scale Standard Deviation 27.2
FACT-Hep-Trial Outcome Index (TOI) 03-05 months post final Rx	101.0 score on a scale Standard Deviation 4.2	92.5 score on a scale Standard Deviation 16.3
FACT-Hep-Trial Outcome Index (TOI) 06-08 months post final Rx	117.0 score on a scale	106.0 score on a scale Standard Deviation 14.8
FACT-Hep-Trial Outcome Index (TOI) 09-11 months post final Rx	—	94.0 score on a scale Standard Deviation 24.8
FACT-Hep-Trial Outcome Index (TOI) 12-14 months post final Rx	—	99.8 score on a scale Standard Deviation 20.1
FACT-Hep-Trial Outcome Index (TOI) 15-17 months post final Rx	—	73.5 score on a scale
FACT-Hep-Trial Outcome Index (TOI) 18-20 months post final Rx	103.0 score on a scale	85.0 score on a scale Standard Deviation 18.4
FACT-Hep-Trial Outcome Index (TOI) 21-23 months post final Rx	—	83.5 score on a scale Standard Deviation 6.4
FACT-Hep-Trial Outcome Index (TOI) 24-26 months post final Rx	—	83.0 score on a scale

Adverse Events

SBRT - 50 Gy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SBRT - 60 Gy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Barbara Stadterman, MPH, CCRP, Clinical Research Manager

UPMC Hillman Cancer Center

Phone: 4126475554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SBRT - 50 Gy n=3 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 Participants Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.	Total n=9 Participants Total of all reporting groups
Age, Continuous	66.0 years n=5 Participants	68.0 years n=7 Participants	66.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
ECOG Performance Score ECOG = 1	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
ECOG Performance Score Unknown	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Karnofsky Score of Performance Status Karnofsky Score = 70	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Karnofsky Score of Performance Status Karnofsky Score = 90	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Karnofsky Score of Performance Status Karnofsky Score = 100	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Karnofsky Score of Performance Status Unknown	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

Measure	SBRT - 50 Gy n=3 participants at risk Stereotactic Body Radiation Therapy: SBRT: Patients received 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.	SBRT - 60 Gy n=6 participants at risk Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
General disorders Fatigue	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	66.7% 4/6 • Adverse event data were collected for a period of up to 5 years.
Hepatobiliary disorders Hepatobiliary disorders - Other, specifyLDH increased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Investigations - Other, specifyedema in lower extremities	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Investigations - Other, specifyLDH increased	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Investigations - Other, specifyRib pain	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Lymphocyte count decreased	66.7% 2/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Neutrophil count decreased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Investigations Platelet count decreased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Investigations White blood cell decreased	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Metabolism and nutrition disorders Hypermagnesemia	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Musculoskeletal and connective tissue disorders Chest wall pain	33.3% 1/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	33.3% 2/6 • Adverse event data were collected for a period of up to 5 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyErythema-right breast	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Adverse event data were collected for a period of up to 5 years.	0.00% 0/6 • Adverse event data were collected for a period of up to 5 years.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse event data were collected for a period of up to 5 years.	16.7% 1/6 • Adverse event data were collected for a period of up to 5 years.