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The study was stopped due to challenges recruiting eligible patients.
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to determine if naloxegol can be used in the treatment of opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of a two week randomized double blind period followed by a two week open-label period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo once daily for two weeks |
|
| Naloxegol | Active Comparator | Naloxegol 25mg tablets once daily for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol | Drug | Naloxegol 25mg tablets for two weeks, followed by a two week open-label period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) for Pain Change From Baseline | Change from baseline in mean daily NRS (Numerical Rating Scale) values will be calculated as the post-baseline value minus the baseline. Baseline NRS is the mean daily NRS values recorded during the Opioid Induced Constipation (OIC) Confirmation period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome. Post-baseline values were calculated as the mean of NRS scores during visits 2-4. | Assessed from screening/Opioid Induced Constipation (OIC) Confirmation period through study completion, approximately 6 weeks. |
| Daily Opioid Use Change From Baseline | Change from baseline in mean daily opioid dose will be calculated as the post-baseline value minus the baseline value. Positive changes from baseline indicate there was a need to increase the opioid dose. Baseline daily opioid dose is the mean daily opioid dose recorded during the Opioid Induced Constipation (OIC) Confirmation period. | Assessed from screening through study completion, approximately 6 weeks. |
| Adverse Events Associated With Blood Laboratory Result Changes From Baseline | Changes from Baseline to Visit 3 (approximately Day 15) for all patients will be calculated as the post-baseline test value minus the baseline test value. | Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
| Electrocardiogram QTC Interval | Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) QTC interval data will be derived by subtracting the baseline value from the final assessment data. | Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
| Electrocardiogram Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Free Bowel Movements (RFBM) Responder Rate | Daily diary data will be used to identify RFBMs. The weekly RFBM frequency within each time period will be calculated as: (Total number of RFBMs during the time period of interest/number of days) x 7. RFBM rate calculated from post baseline period. | Assessed from Baseline through Study Completion, approximately 6 weeks. |
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Inclusion Criteria:
History of constipation, defined through history and through participation in the Screening/OIC Confirmation/Baseline period:
Note: (spontaneous bowel movements (SBMs) are defined as not using a laxative if not already taking daily laxatives, or if taking daily laxatives, not using an additional laxative).
Exclusion Criteria:
Cancer-related/medical comorbidity-related
Other gastrointestinal disorders
Pain-related
Any of the following findings or conditions between the enrollment and randomization visits:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Bull, MD | Hospice of Henderson County, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MJHS Institute for Innovation in Palliative Care | New York | New York | 10006 | United States | ||
| Hospice of Henderson County, Inc |
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To confirm eligibility participants underwent a 7 day baseline assessment/OIC confirmation period. 12 patients provided consent for this study, however 7 did not fulfill eligibility criteria during the 7 day baseline period.
This multi center was conducted at 3 sites in the US. Enrollment to the study was stopped due to recruitment challenges and no new patients have been screened as of January 2018. 5 patients were randomized across the 2 treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo once daily for two weeks Placebo: Placebo once daily for two weeks, followed by two week open-label period |
| FG001 | Naloxegol | Naloxegol 25mg tablets once daily for two weeks Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Period |
| |||||||||||||
| Open-Label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo once daily for two weeks Placebo: Placebo once daily for two weeks, followed by two week open-label period |
| BG001 | Naloxegol | Naloxegol 25mg tablets once daily for two weeks Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numerical Rating Scale (NRS) for Pain Change From Baseline | Change from baseline in mean daily NRS (Numerical Rating Scale) values will be calculated as the post-baseline value minus the baseline. Baseline NRS is the mean daily NRS values recorded during the Opioid Induced Constipation (OIC) Confirmation period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome. Post-baseline values were calculated as the mean of NRS scores during visits 2-4. | Posted | Mean | Full Range | score on a scale | Assessed from screening/Opioid Induced Constipation (OIC) Confirmation period through study completion, approximately 6 weeks. |
|
Occurrences from Baseline through study completion, approximately 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo once daily for two weeks Placebo: Placebo once daily for two weeks, followed by two week open-label period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Due to significant recruitment challenges enrollment was stopped. Only 5 patients were randomized (less than 12% of expected). There was insufficient data to perform the protocol specified analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Bull, MD | Four Seasons Compassion for Life | 8286926178 | 302 | jbull@fourseasonscfl.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2017 | Oct 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003248 | Constipation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Placebo | Drug | Placebo once daily for two weeks, followed by two week open-label period |
|
Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) heart rate data will be derived by subtracting the baseline value from the final assessment data.
| Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
| Change From Baseline in Systolic Blood Pressure | Change from Baseline in systolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Change from Baseline in systolic blood pressure through study completion, approximately 6 weeks. |
| Change From Baseline in Diastolic Blood Pressure | Change from Baseline in diastolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Change from Baseline in diastolic blood pressure through study completion, approximately 6 weeks. |
| Change From Baseline in Respiratory Rate | Change from Baseline in respiratory rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Change from Baseline in respiratory rate through study completion, approximately 6 weeks. |
| Change From Baseline in Pulse Rate | Change from Baseline in pulse rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Change from Baseline in pulse rate through study completion, approximately 6 weeks. |
| Time to First Post-dose Rescue Free Laxation | Time (in hours) to first post-dose rescue free bowel movement minus first dose date and time. | First dose date to first post-dose rescue free bowel movement |
| Bristol Stool Scale (BSS) Score | The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes. Bristol Stool Scale (BSS) Score calculated by the sum of daily BSS scores divided by the number of bowel movements that occurred from baseline to study completion. Change from Baseline calculated as the Baseline value minus the post-baseline value. | Assessed from baseline through Study Completion, approximately 6 weeks. |
| Patient Assessment of Constipation Symptoms (PAC-SYM) | The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse. The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. Change from baseline in mean values calculated as post-baseline value minus baseline value for each scale, and for total. Post-baseline values defined as the mean of day 15 and day 29. | day 1, day 15, day 29 |
| Patient Assessment of Constipation Quality of Life (PAC-QOL) | The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Items 1-4 measure physical discomfort (subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse. The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. Change from baseline in mean values calculated as post-baseline value minus baseline value for each subscale, and for total. Post-baseline values defined as the mean of day 15 and day 29. | day 1, day 15, day 29 |
| Degree of Straining Question With Each Bowel Movement | Degree of straining scale is 1 to 5 with 1 being "not at all" and 5 being "an extreme amount". Lower scores are better and higher scores are worse. Change from baseline in mean values calculated as the post baseline value minus the baseline. Degree of Straining scale change from baseline mean scores calculated from baseline to study completion. | Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks. |
| Complete Evacuation Question With Each Bowel Movement | Change from Baseline in mean values calculated as the post baseline value minus the baseline. The post baseline value is the percentage of days from baseline to study completion with at least one complete bowel evacuation. | Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks. |
| Flat Rock |
| North Carolina |
| 28731 |
| United States |
| Hospice of the Western Reserve, Inc. | Cleveland | Ohio | 44110 | United States |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Numerical Rating Scale (NRS) for Pain | Baseline Numerical Rating Scale (NRS) for Pain during the OIC Confirmation Period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome. | Mean | Full Range | score on a scale |
|
| Baseline Electrocardiogram QTC Interval | Mean | Full Range | Milliseconds |
|
| Baseline Electrocardiogram Heart Rate | Mean | Full Range | beats per minute |
|
| Baseline Daily Opioid Use | Mean | Full Range | morphine milligram equivalents per day |
|
| Baseline Systolic Blood Pressure | Mean | Full Range | mmHg |
|
| Baseline Diastolic Blood Pressure | Mean | Full Range | mmHg |
|
| Baseline Pulse Rate | Mean | Full Range | beats per minute |
|
| Baseline Bristol Stool Scale score | The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes. | Mean | Full Range | score on a scale |
|
| Baseline Respiratory Rate | Mean | Full Range | breaths per minute |
|
| Baseline Degree of Straining | Degree of straining scale measures the amount of straining during a bowel movement. The scale is 1 to 5 with 1 being "not at all" and 5 being "an extreme amount". Lower scores are better and higher scores are worse. | Mean | Full Range | score on a scale |
|
| Baseline Complete Evacuation with Bowel Movements | Mean | Full Range | % of days with complete evacuation |
|
| Baseline Patient Assessment of Constipation Symptom Assessments (PAC-SYM) | The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse. The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. | Mean | Full Range | score on a scale |
|
| Baseline Patient Assessment of Constipation (PAC-QOL) | The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Each item is scored 0-4. Items 1-4 measure physical discomfort (total subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse. The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. | Mean | Full Range | score on a scale |
|
| OG001 |
| Naloxegol |
Naloxegol 25mg tablets once daily for two weeks Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period |
|
|
| Primary | Daily Opioid Use Change From Baseline | Change from baseline in mean daily opioid dose will be calculated as the post-baseline value minus the baseline value. Positive changes from baseline indicate there was a need to increase the opioid dose. Baseline daily opioid dose is the mean daily opioid dose recorded during the Opioid Induced Constipation (OIC) Confirmation period. | Posted | Mean | Full Range | morphine milligram equivalents per day | Assessed from screening through study completion, approximately 6 weeks. |
|
|
|
| Primary | Adverse Events Associated With Blood Laboratory Result Changes From Baseline | Changes from Baseline to Visit 3 (approximately Day 15) for all patients will be calculated as the post-baseline test value minus the baseline test value. | All abnormal lab values were deemed not clinically significant by Investigators. Therefore, changes did not meet the criteria for an adverse event and changes were not collected. | Posted | Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
|
|
| Primary | Electrocardiogram QTC Interval | Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) QTC interval data will be derived by subtracting the baseline value from the final assessment data. | Posted | Mean | Full Range | milliseconds | Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
|
|
|
| Primary | Electrocardiogram Heart Rate | Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) heart rate data will be derived by subtracting the baseline value from the final assessment data. | Posted | Mean | Full Range | beats per minute | Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15) |
|
|
|
| Primary | Change From Baseline in Systolic Blood Pressure | Change from Baseline in systolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Posted | Mean | Full Range | mmHg | Change from Baseline in systolic blood pressure through study completion, approximately 6 weeks. |
|
|
|
| Primary | Change From Baseline in Diastolic Blood Pressure | Change from Baseline in diastolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Posted | Mean | Full Range | mmHg | Change from Baseline in diastolic blood pressure through study completion, approximately 6 weeks. |
|
|
|
| Primary | Change From Baseline in Respiratory Rate | Change from Baseline in respiratory rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Posted | Mean | Full Range | breaths per minute | Change from Baseline in respiratory rate through study completion, approximately 6 weeks. |
|
|
|
| Primary | Change From Baseline in Pulse Rate | Change from Baseline in pulse rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4. | Posted | Mean | Full Range | beats per minute | Change from Baseline in pulse rate through study completion, approximately 6 weeks. |
|
|
|
| Secondary | Rescue Free Bowel Movements (RFBM) Responder Rate | Daily diary data will be used to identify RFBMs. The weekly RFBM frequency within each time period will be calculated as: (Total number of RFBMs during the time period of interest/number of days) x 7. RFBM rate calculated from post baseline period. | Posted | Mean | Full Range | RFBMs/days *7 | Assessed from Baseline through Study Completion, approximately 6 weeks. |
|
|
|
| Secondary | Time to First Post-dose Rescue Free Laxation | Time (in hours) to first post-dose rescue free bowel movement minus first dose date and time. | Posted | Mean | Full Range | Hours | First dose date to first post-dose rescue free bowel movement |
|
|
|
| Secondary | Bristol Stool Scale (BSS) Score | The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes. Bristol Stool Scale (BSS) Score calculated by the sum of daily BSS scores divided by the number of bowel movements that occurred from baseline to study completion. Change from Baseline calculated as the Baseline value minus the post-baseline value. | Posted | Mean | Full Range | score on a scale | Assessed from baseline through Study Completion, approximately 6 weeks. |
|
|
|
| Secondary | Patient Assessment of Constipation Symptoms (PAC-SYM) | The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse. The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. Change from baseline in mean values calculated as post-baseline value minus baseline value for each scale, and for total. Post-baseline values defined as the mean of day 15 and day 29. | Posted | Mean | Full Range | score on a scale | day 1, day 15, day 29 |
|
|
|
| Secondary | Patient Assessment of Constipation Quality of Life (PAC-QOL) | The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Items 1-4 measure physical discomfort (subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse. The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes. Change from baseline in mean values calculated as post-baseline value minus baseline value for each subscale, and for total. Post-baseline values defined as the mean of day 15 and day 29. | Posted | Mean | Full Range | score on a scale | day 1, day 15, day 29 |
|
|
|
| Secondary | Degree of Straining Question With Each Bowel Movement | Degree of straining scale is 1 to 5 with 1 being "not at all" and 5 being "an extreme amount". Lower scores are better and higher scores are worse. Change from baseline in mean values calculated as the post baseline value minus the baseline. Degree of Straining scale change from baseline mean scores calculated from baseline to study completion. | Posted | Mean | Full Range | score on a scale | Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks. |
|
|
|
| Secondary | Complete Evacuation Question With Each Bowel Movement | Change from Baseline in mean values calculated as the post baseline value minus the baseline. The post baseline value is the percentage of days from baseline to study completion with at least one complete bowel evacuation. | Posted | Mean | Full Range | % of days with complete evacuation | Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks. |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Naloxegol | Naloxegol 25mg tablets once daily for two weeks Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period | 0 | 3 | 0 | 3 | 3 | 3 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| chills | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal distention | General disorders | Systematic Assessment |
|
| bladder spasms | Renal and urinary disorders | Systematic Assessment |
|
| increased back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| increased abdominal pain | General disorders | Systematic Assessment |
|
| worsening constipation | Gastrointestinal disorders | Systematic Assessment |
|
| mental status changes | Nervous system disorders | Systematic Assessment |
|
| abdominal cramping | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
| Stool Symptoms |
|
| Total Score |
|
| Worries/concerns |
|
| Satisfaction |
|
| Total Score |
|