Chemotherapy-induced Diarrhea
Conditions
Keywords
Colorectal cancer, diarrhea, drug therapy, octreotide, fluorouracil, irinotecan, capecitabine, prevention
Brief summary
This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer.
Detailed description
Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin, Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin, Bevacizumab or Cetuximab. Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal Growth Factor Receptor (EGFR)-inhibitors, will not be eligible. The acute treatment for diarrhea will be left to physician's discretion in both groups. Patients in the control arm will be treated without Octreotide LAR. Patients in the experimental arm will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. Patient evaluation will be done at each cycle for efficacy and toxicity.
Interventions
DRUGOctreotide Long Acting Release
Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first.
OTHERStandard Treatment
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Providing a written informed consent 2. Age between 18 and 80 years; 3. Histological diagnosis of colorectal cancer, presence of metastatic disease and no prior systemic therapy for metastatic disease (prior adjuvant therapy will be allowed if completed 6 months or longer before inclusion in the study); 4. Indication of treatment, according to the judgment of the investigator, with a chemotherapy regimen containing either 5-FU, capecitabine, or irinotecan; any such regimen may also include oxaliplatin, bevacizumab, or cetuximab; 5. A performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale 6. Adequate organ function and lab values within specific ranges 7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration; 8. Fertile patients (male or female) must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months after study termination; 9. No prior use of octreotide in any formulation.
Exclusion criteria
1. Use of concomitant antineoplastic treatments, other than regimens containing either 5-FU, capecitabine, or irinotecan with or without oxaliplatin, bevacizumab, or cetuximab; 2. Previous or concomitant need for radiotherapy to the abdomen or pelvis; 3. Indication of treatment, according to the judgment of the investigator, with erlotinib, gefitinib, panitumumab, or other EGFR-inhibitors other than cetuximab; 4. A second malignancy (except in situ carcinoma of the cervix, in situ carcinoma of the bladder, adequately treated basal-cell or squamous-cell carcinoma of the skin, or another malignancy treated more than 5 years prior to enrollment and without recurrence); 5. Any type of condition leading to chronic diarrhea, including, but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), chronic diarrhea of presumed or confirmed infectious origin, and irritable bowel syndrome; 6. Active or uncontrolled concurrent medical condition, including, but not limited to, unstable angina, congestive heart failure, coronary artery disease, hypertension, diabetes mellitus, and hyper- or hypothyroidism; 7. Active and ongoing systemic infection; 8. Serious uncontrolled psychiatric illness; 9. Ongoing pregnancy or lactation; 10. Female patients who are pregnant or lactating, or are of childbearing potential and would not practice a medically acceptable method for birth control; 11. Lesions that have been irradiated cannot be included as sites of measurable disease. If the only measurable lesion was previously irradiated the patient cannot be included; 12. Use of any investigational agent within 30 days prior to enrollment in the study or foreseen use of an investigational agent during the study; 13. History of chronic (≥ 30 nonconsecutive days) use of laxatives; 14. Concurrent use of antidiarrheal agents; 15. Inability to comply with the study protocol. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Developing Diarrhea (Grade 1 to 4) | 6 month overall | The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Episodes of Diarrhea by Patient by Cycle | at each cycle (28 days per cycle) | Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.) |
| Percentage of Patients by Grade of Diarrhea | 6 months overall | Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. |
| Percentage of Participants Who Need Opioids for Control of Diarrhea | 6 months overall | — |
| Percentage of Episodes by Grade | 6 months overall | Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. |
| Number of Episodes of Diarrhea by Patient | 6 months overall | Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis. |
| Percentage of Patients Hospitalized Due to Diarrhea | 6 months overall | — |
| Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea | 6 months overall | — |
| Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 56, Day 84, Day 112, Day 140, Day 168 | Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as \> 20 mm with conventional techniques (CT, MRI) or as \> 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. |
| Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) | Baseline to Day 168 | Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point. |
| Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea | 6 months overall | For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octreotide Long Acting Release Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy. | 68 |
| Standard Treatment Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. | 71 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Death | 4 | 3 |
| Overall Study | Disease Progression | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 6 | 2 |
| Overall Study | Use of illicit drugs | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Octreotide Long Acting Release | Standard Treatment | Total |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 12.8 | 55.5 years STANDARD_DEVIATION 11.4 | 55.85 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 37 Participants | 41 Participants | 78 Participants |
| Sex: Female, Male Male | 31 Participants | 30 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 68 | 68 / 71 |
| serious Total, serious adverse events | 15 / 68 | 14 / 71 |
Outcome results
Primary
Percentage of Participants Developing Diarrhea (Grade 1 to 4)
The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Time frame: 6 month overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octreotide Long Acting Release | Percentage of Participants Developing Diarrhea (Grade 1 to 4) | 76.1 Percentage of Participants |
| Standard Treatment | Percentage of Participants Developing Diarrhea (Grade 1 to 4) | 78.9 Percentage of Participants |
Secondary
Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)
Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.
Time frame: Baseline to Day 168
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octreotide Long Acting Release | Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) | 0.5 Units on a scale | Standard Deviation 1.9 |
| Standard Treatment | Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) | 3.4 Units on a scale | Standard Deviation 2 |
Secondary
Number of Episodes of Diarrhea by Patient
Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient | 21.6 Episodes/patients/day | Standard Deviation 24.3 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient | 20.4 Episodes/patients/day | Standard Deviation 19.6 |
Secondary
Number of Episodes of Diarrhea by Patient by Cycle
Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)
Time frame: at each cycle (28 days per cycle)
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. n indicates patients with observations during each cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 3 (n=33,39) | 6.9 Episodes/patient/cycle | Standard Deviation 7.8 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 5 (n=20,29) | 8.1 Episodes/patient/cycle | Standard Deviation 7.1 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 2 (n=36,38) | 8.2 Episodes/patient/cycle | Standard Deviation 6.8 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 6 (n=22, 22) | 6.1 Episodes/patient/cycle | Standard Deviation 6.9 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 4 (n=24, 27) | 8.6 Episodes/patient/cycle | Standard Deviation 7.1 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 7 (n= 16, 20) | 4.8 Episodes/patient/cycle | Standard Deviation 6.3 |
| Octreotide Long Acting Release | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 1 (n=20, 18) | 2.6 Episodes/patient/cycle | Standard Deviation 2.2 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 7 (n= 16, 20) | 6.6 Episodes/patient/cycle | Standard Deviation 6.4 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 1 (n=20, 18) | 2.2 Episodes/patient/cycle | Standard Deviation 2 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 2 (n=36,38) | 5.9 Episodes/patient/cycle | Standard Deviation 6.2 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 3 (n=33,39) | 6.7 Episodes/patient/cycle | Standard Deviation 6.5 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 4 (n=24, 27) | 7.1 Episodes/patient/cycle | Standard Deviation 7.1 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 5 (n=20,29) | 7 Episodes/patient/cycle | Standard Deviation 8.8 |
| Standard Treatment | Number of Episodes of Diarrhea by Patient by Cycle | Cycle 6 (n=22, 22) | 5.8 Episodes/patient/cycle | Standard Deviation 5.3 |
Secondary
Percentage of Episodes by Grade
Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide Long Acting Release | Percentage of Episodes by Grade | Grade 1 | 65.4 Percentage of Episodes |
| Octreotide Long Acting Release | Percentage of Episodes by Grade | Grade 2 | 23.3 Percentage of Episodes |
| Octreotide Long Acting Release | Percentage of Episodes by Grade | Grade 3 | 11.3 Percentage of Episodes |
| Octreotide Long Acting Release | Percentage of Episodes by Grade | Grade 4 | 0 Percentage of Episodes |
| Standard Treatment | Percentage of Episodes by Grade | Grade 4 | 0 Percentage of Episodes |
| Standard Treatment | Percentage of Episodes by Grade | Grade 1 | 66.9 Percentage of Episodes |
| Standard Treatment | Percentage of Episodes by Grade | Grade 3 | 5.9 Percentage of Episodes |
| Standard Treatment | Percentage of Episodes by Grade | Grade 2 | 27.2 Percentage of Episodes |
Secondary
Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea
For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octreotide Long Acting Release | Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea | 26.9 Percentage of participants |
| Standard Treatment | Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea | 11.3 Percentage of participants |
Secondary
Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octreotide Long Acting Release | Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea | 4.5 Percentage of Participants |
| Standard Treatment | Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea | 7.0 Percentage of Participants |
Secondary
Percentage of Participants Who Need Opioids for Control of Diarrhea
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octreotide Long Acting Release | Percentage of Participants Who Need Opioids for Control of Diarrhea | 1.5 Percentage of Participants |
| Standard Treatment | Percentage of Participants Who Need Opioids for Control of Diarrhea | 1.4 Percentage of Participants |
Secondary
Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)
Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as \> 20 mm with conventional techniques (CT, MRI) or as \> 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.
Time frame: Day 56, Day 84, Day 112, Day 140, Day 168
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. N in each category indicates the number of patients analyzed with observations at that timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide Long Acting Release | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 84 (N=5,3) | 60.0 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 140 (N=9,1) | 44.4 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 112 (N=1,1) | 100 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 168 (N=2,1) | 100 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 56 (N=11,2) | 45.5 Percentage of Participants |
| Standard Treatment | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 168 (N=2,1) | 100 Percentage of Participants |
| Standard Treatment | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 56 (N=11,2) | 0.0 Percentage of Participants |
| Standard Treatment | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 84 (N=5,3) | 100 Percentage of Participants |
| Standard Treatment | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 112 (N=1,1) | 0.0 Percentage of Participants |
| Standard Treatment | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Day 140 (N=9,1) | 100 Percentage of Participants |
Secondary
Percentage of Patients by Grade of Diarrhea
Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide Long Acting Release | Percentage of Patients by Grade of Diarrhea | Grade 4 | 0 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Patients by Grade of Diarrhea | Grade 1 | 41.2 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Patients by Grade of Diarrhea | Grade 2 | 25.5 Percentage of Participants |
| Octreotide Long Acting Release | Percentage of Patients by Grade of Diarrhea | Grade 3 | 33.3 Percentage of Participants |
| Standard Treatment | Percentage of Patients by Grade of Diarrhea | Grade 3 | 21.4 Percentage of Participants |
| Standard Treatment | Percentage of Patients by Grade of Diarrhea | Grade 4 | 0 Percentage of Participants |
| Standard Treatment | Percentage of Patients by Grade of Diarrhea | Grade 2 | 51.8 Percentage of Participants |
| Standard Treatment | Percentage of Patients by Grade of Diarrhea | Grade 1 | 26.8 Percentage of Participants |
Secondary
Percentage of Patients Hospitalized Due to Diarrhea
Time frame: 6 months overall
Population: ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octreotide Long Acting Release | Percentage of Patients Hospitalized Due to Diarrhea | 6 Percentage of patients |
| Standard Treatment | Percentage of Patients Hospitalized Due to Diarrhea | 4.2 Percentage of patients |