Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
RRMS, Multiple Sclerosis, MS, Alkermes, ALKS 8700, Dimethyl Fumarate, DMF, Tecfidera
Brief summary
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
Interventions
DRUGDimethyl Fumarate
Administered as specified in the treatment arm.
DRUGALKS 8700
Administered as specified in the treatment arm.
Sponsors
Alkermes, Inc.
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Capable of understanding and complying with the protocol * Has a confirmed diagnosis of RRMS * Neurologically stable with no evidence of relapse within 30 days prior to randomization * Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal Key
Exclusion criteria
* Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study * Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS * History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial * History of GI surgery (except appendectomy that occurred more than 6 months prior to screening * History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening * Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening * History of a myocardial infarction, including a silent myocardial infarction or unstable angina * History of clinically significant drug or alcohol abuse within the past year prior to screening * Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months * Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration * Prior use of Dimethyl Fumarate (DMF) NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B | End of treatment (up to Week 6) for Part B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. |
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. |
| Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. |
| Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. |
| Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. |
| Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period. |
| Number of Participants With Adverse Events (AEs) | End of study (up to Week 10) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | End of treatment (up to Week 6) for both Parts A and B | GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries. |
Countries
Germany, Poland, United States
Participant flow
Recruitment details
Participants were enrolled at 70 investigative sites in the United States (US), Germany, and Poland from March 15, 2017 to June 27, 2019.
Pre-assignment details
A total of 506 participants with relapsing remitting multiple-sclerosis were enrolled in this study. Of which 504 participants received study drug and randomized in Parts A and B of the study (253 participants in ALKS 8700 group and 251 in Dimethyl Fumarate group). A total of 478 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 8700 Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. | 253 |
| Dimethyl Fumarate (DMF) Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5. | 251 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 15 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Deviation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Dimethyl Fumarate (DMF) | Total | ALKS 8700 |
|---|---|---|---|
| Age, Continuous | 43.7 years STANDARD_DEVIATION 9.9 | 43.7 years STANDARD_DEVIATION 10.44 | 43.7 years STANDARD_DEVIATION 10.96 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 40 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 15 Participants | 5 Participants |
| Race/Ethnicity, Customized Multiple races | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 241 Participants | 489 Participants | 248 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 227 Participants | 459 Participants | 232 Participants |
| Sex: Female, Male Female | 190 Participants | 367 Participants | 177 Participants |
| Sex: Female, Male Male | 61 Participants | 137 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 253 | 0 / 251 |
| other Total, other adverse events | 175 / 253 | 191 / 251 |
| serious Total, serious adverse events | 4 / 253 | 3 / 251 |
Outcome results
Primary
Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The full analysis set (FAS) population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | 1.5 days | Standard Deviation 2.85 |
| Dimethyl Fumarate (DMF) | Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | 2.5 days | Standard Deviation 4.68 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.000395% CI: [0.39, 0.754]Negative Binomial Regression Model
Secondary
Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | 1.1 days | Standard Deviation 3.25 |
| Dimethyl Fumarate (DMF) | Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B | 1.5 days | Standard Deviation 3.53 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.06895% CI: [0.425, 1.031]Negative Binomial Regression Model
Secondary
Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | 0.7 days | Standard Deviation 2.26 |
| Dimethyl Fumarate (DMF) | Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | 0.9 days | Standard Deviation 2.57 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.21595% CI: [0.417, 1.217]Negative Binomial Regression Model
Secondary
Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | 2.1 days | Standard Deviation 4.43 |
| Dimethyl Fumarate (DMF) | Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | 2.8 days | Standard Deviation 5.19 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.03395% CI: [0.499, 0.972]Negative Binomial Regression Model
Secondary
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | 2.9 days | Standard Deviation 4.46 |
| Dimethyl Fumarate (DMF) | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B | 3.9 days | Standard Deviation 5.84 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.00995% CI: [0.554, 0.921]Negative Binomial Regression Model
Secondary
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for Part B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B | 1.3 days | Standard Deviation 2.7 |
| Dimethyl Fumarate (DMF) | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B | 2.2 days | Standard Deviation 4.22 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.000795% CI: [0.356, 0.76]Negative Binomial Regression Model
Secondary
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 8700 | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | 0.9 days | Standard Deviation 2.25 |
| Dimethyl Fumarate (DMF) | Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B | 1.5 days | Standard Deviation 3.85 |
Comparison: Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).p-value: 0.00995% CI: [0.357, 0.862]Negative Binomial Regression Model
Secondary
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: End of study (up to Week 10)
Population: The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALKS 8700 | Number of Participants With Adverse Events (AEs) | 198 participants |
| Dimethyl Fumarate (DMF) | Number of Participants With Adverse Events (AEs) | 210 participants |
Secondary
Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period.
Time frame: End of treatment (up to Week 6) for both Parts A and B
Population: The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALKS 8700 | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Vomiting | 0.2 score on a scale | Standard Deviation 0.74 |
| ALKS 8700 | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Lower Abdominal Pain | 0.8 score on a scale | Standard Deviation 1.6 |
| ALKS 8700 | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Nausea | 0.9 score on a scale | Standard Deviation 1.55 |
| ALKS 8700 | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Diarrhea | 1.1 score on a scale | Standard Deviation 2.09 |
| ALKS 8700 | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Upper Abdominal Pain | 0.8 score on a scale | Standard Deviation 1.58 |
| Dimethyl Fumarate (DMF) | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Diarrhea | 1.3 score on a scale | Standard Deviation 2.19 |
| Dimethyl Fumarate (DMF) | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Nausea | 1.2 score on a scale | Standard Deviation 1.98 |
| Dimethyl Fumarate (DMF) | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Vomiting | 0.6 score on a scale | Standard Deviation 1.84 |
| Dimethyl Fumarate (DMF) | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Upper Abdominal Pain | 1.3 score on a scale | Standard Deviation 2.06 |
| Dimethyl Fumarate (DMF) | Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B | Lower Abdominal Pain | 1.0 score on a scale | Standard Deviation 1.84 |
Comparison: Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.p-value: 0.04395% CI: [-0.6, 0]ANCOVA
Comparison: Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.p-value: <0.00195% CI: [-0.7, -0.2]ANCOVA
Comparison: Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.p-value: 0.00195% CI: [-0.9, -0.2]ANCOVA
Comparison: Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.p-value: 0.40395% CI: [-0.4, 0.2]ANCOVA
Comparison: Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.p-value: 0.26195% CI: [-0.6, 0.2]ANCOVA