Healthy
Conditions
Keywords
BG00012, gastrointestinal events, flushing events, dose titration, pre-medication, aspirin
Brief summary
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.
Interventions
DRUGBG00012 (dimethyl fumarate)
Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.
DRUGBG00012 placebo
Placebo matching BG00012
DRUGASA
325 mg microcoated aspirin (ASA)
DRUGASA placebo
Placebo matching aspirin
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Must give written informed consent and any authorizations required by local law * Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m\^2,inclusive. * Ability to complete the tolerability scales by accurately using the hand-held subject reporting device * Subjects of childbearing potential must be willing to practice effective contraception Key
Exclusion criteria
* History of clinically significant diseases * History of severe allergic or anaphylactic reactions * Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) * Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1 NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | Week 5 to Week 8 | The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. |
| Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Day 1 to Week 4 | Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). |
| Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Week 5 to Week 8 | Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). |
| Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) | Day 2 to Week 8 | Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. |
| Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS | Day 2 to Week 4 | Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. |
| Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS | Week 5 to Week 8 | Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score. |
| Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) | Day 1 to Week 8 | The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. |
| Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Day 1 to Week 4 | The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. |
| Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Week 5 to Week 8 | The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. |
| Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Day 1 to Week 4 | Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. |
| Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Week 5 to Week 8 | Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. |
| Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | Day 1 to Week 8 | The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. |
| Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | Week 1 to Week 4 | The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. |
| Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Day 1 to Week 8 | Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). |
| Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Week 1 to Week 4 | Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). |
| Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Week 5 to Week 8 | Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Day 1 to Week 8 | Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute |
| Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Day 1 to Week 8 | Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen. |
| Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Day 1 to Week 8 | Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells. |
| Number of Participants With Abnormalities in Vital Signs | Day 1 to Week 8 | ↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute |
| Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Day 1 to Week 8 | Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.' |
| Duration of Flushing Events During the Overall Treatment Period, Based on MFSS | Day 1 to Week 8 | For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. |
| Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS | Week 1 to Week 4 | For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. |
| Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS | Week 5 to Week 8 | For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. |
| Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Day 1 to Week 8 | Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. |
| Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Week 1 to Week 4 | Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. |
| Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Week 5 to Week 8 | Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Day 1 up to end of Safety Follow-up (9 weeks) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks. | 44 |
| BG00012 Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks. | 43 |
| BG00012 + ASA Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks. | 43 |
| BG00012 Slow Titration Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks. | 42 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Randomized But Not Treated | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Physician | 1 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 0 | 7 |
| Overall Study | Withdrew due to Adverse Event | 2 | 4 | 6 | 3 |
Baseline characteristics
| Characteristic | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 8.78 | 39.0 years STANDARD_DEVIATION 9.61 | 38.1 years STANDARD_DEVIATION 10.29 | 36.2 years STANDARD_DEVIATION 9.33 | 37.2 years STANDARD_DEVIATION 9.54 |
| Age, Customized 25 to 34 years | 22 participants | 19 participants | 17 participants | 21 participants | 79 participants |
| Age, Customized 35 to 44 years | 13 participants | 7 participants | 13 participants | 10 participants | 43 participants |
| Age, Customized 45 to 55 years | 9 participants | 17 participants | 13 participants | 11 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 17 Participants | 20 Participants | 72 Participants |
| Sex: Female, Male Male | 30 Participants | 22 Participants | 26 Participants | 22 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 44 | 12 / 43 | 15 / 43 | 12 / 42 |
| serious Total, serious adverse events | 0 / 44 | 1 / 43 | 0 / 43 | 0 / 42 |
Outcome results
Primary
Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Time frame: Day 1 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) | 73 percentage of participants |
| BG00012 | Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) | 81 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) | 81 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS) | 86 percentage of participants |
95% CI: [-22, 22]
95% CI: [-16.4, 25.5]
Primary
Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Time frame: Day 1 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 59 percentage of participants |
| BG00012 | Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 70 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 79 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 79 percentage of participants |
95% CI: [-11.8, 30]
95% CI: [-11.8, 30]
Primary
Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Time frame: Week 1 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 57 percentage of participants |
| BG00012 | Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 65 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 67 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 71 percentage of participants |
95% CI: [-18.8, 23.3]
95% CI: [-14.1, 27.8]
Primary
Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Time frame: Day 1 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | 66 percentage of participants |
| BG00012 | Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | 81 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | 79 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | 79 percentage of participants |
95% CI: [-24.2, 19.7]
95% CI: [-23.3, 18.7]
Primary
Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 34 percentage of participants |
| BG00012 | Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 59 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 50 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) | 58 percentage of participants |
95% CI: [-32.1, 14.3]
95% CI: [-25, 21.7]
Primary
Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | 41 percentage of participants |
| BG00012 | Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | 59 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | 53 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | 61 percentage of participants |
95% CI: [-29.4, 17.1]
95% CI: [-22.1, 24.5]
Primary
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Day 1 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall tingling events | 23 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall redness events | 27 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall itching events | 20 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall warmth events | 41 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall flushing events | 41 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall warmth events | 93 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall tingling events | 88 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall itching events | 86 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall redness events | 86 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall flushing events | 91 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall warmth events | 84 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall flushing events | 81 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall redness events | 77 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall tingling events | 67 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall itching events | 72 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall tingling events | 86 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall redness events | 90 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall flushing events | 98 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall warmth events | 98 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS) | Overall itching events | 98 percentage of participants |
Comparison: Overall flushing events95% CI: [-30.8, 12.9]
Comparison: Overall flushing events95% CI: [-14.1, 27.8]
Comparison: Overall redness events95% CI: [-30.8, 12.9]
Comparison: Overall redness events95% CI: [-16.4, 25.5]
Comparison: Overall tingling events95% CI: [-41.7, 1.3]
Comparison: Overall tingling events95% CI: [-23.3, 18.7]
Comparison: Overall itching events95% CI: [-35.2, 8.3]
Comparison: Overall itching events95% CI: [-9.5, 32.2]
Comparison: Overall warmth events95% CI: [-30.8, 12.9]
Comparison: Overall warmth events95% CI: [-16.4, 25.5]
Primary
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Time frame: Day 2 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) | 43 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) | 86 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) | 74 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) | 93 percentage of participants |
Comparison: Overall flushing events95% CI: [-32.2, 9.5]
Comparison: Overall flushing events95% CI: [-14.1, 27.8]
Primary
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 1 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall tingling events | 23 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall redness events | 25 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall itching events | 16 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall warmth events | 41 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall flushing events | 41 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall warmth events | 88 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall tingling events | 84 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall itching events | 77 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall redness events | 81 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall flushing events | 86 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall warmth events | 67 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall flushing events | 72 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall redness events | 63 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall tingling events | 51 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall itching events | 56 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall tingling events | 83 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall redness events | 88 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall flushing events | 98 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall warmth events | 95 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS | Overall itching events | 95 percentage of participants |
Comparison: Overall flushing events95% CI: [-35.2, 8.3]
Comparison: Overall flushing events95% CI: [-9.5, 32.2]
Comparison: Redness events95% CI: [-39.6, 3.7]
Comparison: Redness events95% CI: [-14.1, 27.8]
Comparison: Warmth events95% CI: [-41.7, 1.3]
Comparison: Warmth events95% CI: [-14.1, 27.8]
Comparison: Tingling events95% CI: [-52.2, -10.6]
Comparison: Tingling events95% CI: [-21, 21]
Comparison: Itching events95% CI: [-41.7, 1.3]
Comparison: Itching events95% CI: [-2.4, 38.8]
Primary
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS
Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Time frame: Day 2 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS | 41 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS | 84 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS | 62 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS | 90 percentage of participants |
95% CI: [-41, 0.1]
95% CI: [-14.1, 27.8]
Primary
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall tingling events | 15 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall redness events | 15 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall itching events | 22 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall warmth events | 17 percentage of participants |
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall flushing events | 24 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall warmth events | 86 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall tingling events | 81 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall itching events | 78 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall redness events | 78 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall flushing events | 86 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall warmth events | 75 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall flushing events | 72 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall redness events | 64 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall tingling events | 64 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall itching events | 58 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall tingling events | 70 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall redness events | 79 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall flushing events | 85 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall warmth events | 82 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS | Overall itching events | 61 percentage of participants |
Comparison: Warmth events95% CI: [-33, 11.9]
Comparison: Warmth events95% CI: [-27.5, 18.8]
Comparison: Tingling events95% CI: [-38.1, 6.5]
Comparison: Tingling events95% CI: [-34.2, 12.2]
Comparison: Itching events95% CI: [-40.6, 3.8]
Comparison: Itching events95% CI: [-40.2, 5.5]
Comparison: Overall flushing events95% CI: [-35.6, 9.2]
Comparison: Overall flushing events95% CI: [-24.7, 21.7]
Comparison: Redness events95% CI: [-35.6, 9.2]
Comparison: Redness events95% CI: [-22.9, 23.7]
Primary
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS
Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS | 24 percentage of participants |
| BG00012 | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS | 86 percentage of participants |
| BG00012 + ASA | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS | 67 percentage of participants |
| BG00012 Slow Titration | Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS | 85 percentage of participants |
95% CI: [-40.6, 3.8]
95% CI: [-24.7, 21.7]
Primary
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Time frame: Day 1 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.4 units on a scale | Standard Deviation 1.45 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.7 units on a scale | Standard Deviation 1.29 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 1.3 units on a scale | Standard Deviation 1.73 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 0.5 units on a scale | Standard Deviation 1.21 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 0.8 units on a scale | Standard Deviation 1.38 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.0 units on a scale | Standard Deviation 1.97 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Bloating | 0.5 units on a scale | Standard Deviation 1.17 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.2 units on a scale | Standard Deviation 0.75 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Nausea | 0.7 units on a scale | Standard Deviation 1.59 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.3 units on a scale | Standard Deviation 1.28 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.9 units on a scale | Standard Deviation 2.23 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.9 units on a scale | Standard Deviation 1.83 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.8 units on a scale | Standard Deviation 2.47 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Nausea | 1.6 units on a scale | Standard Deviation 2.41 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 1.1 units on a scale | Standard Deviation 2.16 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 1.3 units on a scale | Standard Deviation 2.03 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Bloating | 1.1 units on a scale | Standard Deviation 1.96 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 1.4 units on a scale | Standard Deviation 2.14 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.3 units on a scale | Standard Deviation 1.63 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Nausea | 1.6 units on a scale | Standard Deviation 2.54 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.5 units on a scale | Standard Deviation 2.76 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 1.7 units on a scale | Standard Deviation 2.71 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 1.3 units on a scale | Standard Deviation 2.32 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.6 units on a scale | Standard Deviation 1.26 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.6 units on a scale | Standard Deviation 1.45 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Bloating | 1.3 units on a scale | Standard Deviation 2.08 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 1.4 units on a scale | Standard Deviation 1.76 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.9 units on a scale | Standard Deviation 1.85 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 1.2 units on a scale | Standard Deviation 2.12 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 1.4 units on a scale | Standard Deviation 2.47 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 1.6 units on a scale | Standard Deviation 2.2 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Bloating | 1.0 units on a scale | Standard Deviation 1.88 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.0 units on a scale | Standard Deviation 1.67 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.9 units on a scale | Standard Deviation 1.97 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.2 units on a scale | Standard Deviation 1.1 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS | Nausea | 1.5 units on a scale | Standard Deviation 2.09 |
Comparison: Nausea95% CI: [-1.1, 1.1]
Comparison: Nausea95% CI: [-1.1, 0.9]
Comparison: Diarrhea95% CI: [-1.4, 0.8]
Comparison: Diarrhea95% CI: [-1.7, 0.1]
Comparison: Upper abdominal pain95% CI: [-0.5, 1.6]
Comparison: Upper abdominal pain95% CI: [-0.7, 1.3]
Comparison: Lower abdominal pain95% CI: [-1, 0.9]
Comparison: Lower abdominal pain95% CI: [-1.1, 0.8]
Comparison: Vomiting95% CI: [-0.6, 0.7]
Comparison: Vomiting95% CI: [-0.6, 0.5]
Comparison: Indigestion95% CI: [-1, 0.3]
Comparison: Indigestion95% CI: [-0.8, 0.8]
Comparison: Constipation95% CI: [-1, 0.6]
Comparison: Constipation95% CI: [-0.8, 0.9]
Comparison: Bloating95% CI: [-0.7, 1.1]
Comparison: Bloating95% CI: [-0.9, 0.7]
Comparison: Flatulence95% CI: [-0.8, 0.9]
Comparison: Flatulence95% CI: [-0.7, 1.1]
Primary
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.4 units on a scale | Standard Deviation 1.26 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 0.8 units on a scale | Standard Deviation 1.65 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 0.6 units on a scale | Standard Deviation 1.48 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 0.6 units on a scale | Standard Deviation 1.69 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.0 units on a scale | Standard Deviation 2.01 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Bloating | 0.5 units on a scale | Standard Deviation 1.23 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.2 units on a scale | Standard Deviation 1.41 |
| Placebo | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Nausea | 0.4 units on a scale | Standard Deviation 1.51 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.1 units on a scale | Standard Deviation 0.82 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.1 units on a scale | Standard Deviation 0.59 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.5 units on a scale | Standard Deviation 1.32 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 1.4 units on a scale | Standard Deviation 2.29 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Nausea | 0.9 units on a scale | Standard Deviation 1.79 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 0.5 units on a scale | Standard Deviation 1.5 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 1.2 units on a scale | Standard Deviation 2.04 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Bloating | 0.7 units on a scale | Standard Deviation 1.61 |
| BG00012 | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 0.4 units on a scale | Standard Deviation 1.42 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.1 units on a scale | Standard Deviation 0.83 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Nausea | 0.8 units on a scale | Standard Deviation 1.94 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 0.8 units on a scale | Standard Deviation 2.13 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 0.4 units on a scale | Standard Deviation 1.21 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 0.5 units on a scale | Standard Deviation 1.38 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.5 units on a scale | Standard Deviation 1.38 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.6 units on a scale | Standard Deviation 1.63 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Bloating | 0.7 units on a scale | Standard Deviation 1.55 |
| BG00012 + ASA | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 0.4 units on a scale | Standard Deviation 1.08 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Constipation | 0.3 units on a scale | Standard Deviation 1.05 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Lower abdominal pain | 0.9 units on a scale | Standard Deviation 1.72 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Upper abdominal pain | 0.6 units on a scale | Standard Deviation 1.56 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Flatulence | 0.9 units on a scale | Standard Deviation 1.54 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Bloating | 0.8 units on a scale | Standard Deviation 1.52 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Diarrhea | 0.7 units on a scale | Standard Deviation 1.42 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Indigestion | 0.4 units on a scale | Standard Deviation 1.06 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Vomiting | 0.0 units on a scale | Standard Deviation 0 |
| BG00012 Slow Titration | Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS | Nausea | 0.9 units on a scale | Standard Deviation 1.65 |
Comparison: Nausea95% CI: [-1, 0.8]
Comparison: Nausea95% CI: [-0.8, 0.8]
Comparison: Diarrhea95% CI: [-1.7, 0.4]
Comparison: Diarrhea95% CI: [-1.7, 0.2]
Comparison: Upper abdominal pain95% CI: [-0.7, 0.6]
Comparison: Upper abdominal pain95% CI: [-0.7, 0.8]
Comparison: Lower abdominal pain95% CI: [-0.6, 0.7]
Comparison: Lower abdominal pain95% CI: [-0.2, 1.3]
Comparison: Vomiting95% CI: [-0.4, 0.4]
Comparison: Vomiting95% CI: [-0.4, 0.2]
Comparison: Indigestion95% CI: [-0.6, 0.6]
Comparison: Indigestion95% CI: [-0.7, 0.5]
Comparison: Constipation95% CI: [-0.1, 1]
Comparison: Constipation95% CI: [-0.2, 0.6]
Comparison: Bloating95% CI: [-0.8, 0.7]
Comparison: Bloating95% CI: [-0.7, 0.8]
Comparison: Flatulence95% CI: [-1.6, 0]
Comparison: Flatulence95% CI: [-1.2, 0.5]
Primary
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Day 1 to Week 4
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Tingling | 0.5 units on a scale | Standard Deviation 1 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Redness | 0.7 units on a scale | Standard Deviation 1.33 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Itching | 0.5 units on a scale | Standard Deviation 1.21 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Warmth | 1.2 units on a scale | Standard Deviation 1.76 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 1.2 units on a scale | Standard Deviation 1.7 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Warmth | 4.0 units on a scale | Standard Deviation 2.55 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Tingling | 3.4 units on a scale | Standard Deviation 2.21 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Itching | 3.2 units on a scale | Standard Deviation 2.45 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Redness | 3.8 units on a scale | Standard Deviation 2.76 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 4.4 units on a scale | Standard Deviation 2.68 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Warmth | 2.3 units on a scale | Standard Deviation 2.17 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 2.4 units on a scale | Standard Deviation 2.26 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Redness | 1.6 units on a scale | Standard Deviation 1.75 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Tingling | 1.6 units on a scale | Standard Deviation 2.13 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Itching | 1.3 units on a scale | Standard Deviation 1.72 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Tingling | 4.0 units on a scale | Standard Deviation 2.62 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Redness | 5.1 units on a scale | Standard Deviation 2.93 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 5.6 units on a scale | Standard Deviation 2.24 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Warmth | 5.2 units on a scale | Standard Deviation 2.37 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS | Itching | 4.3 units on a scale | Standard Deviation 2.1 |
Comparison: Overall flushing events95% CI: [-3, -0.9]
Comparison: Overall flushing events95% CI: [0.2, 2.3]
Comparison: Redness events95% CI: [-3.2, -1.2]
Comparison: Redness events95% CI: [0.1, 2.5]
Comparison: Warmth events95% CI: [-2.8, -0.7]
Comparison: Warmth events95% CI: [0.1, 2.3]
Comparison: Tingling events95% CI: [-2.7, -0.9]
Comparison: Tingling events95% CI: [-0.4, 1.6]
Comparison: Itching events95% CI: [-2.8, -1]
Comparison: Itching events95% CI: [0.2, 2.2]
Primary
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 8
Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Tingling | 0.3 units on a scale | Standard Deviation 0.82 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Redness | 0.4 units on a scale | Standard Deviation 1.14 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Itching | 0.7 units on a scale | Standard Deviation 1.58 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Warmth | 0.8 units on a scale | Standard Deviation 1.79 |
| Placebo | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 0.9 units on a scale | Standard Deviation 1.67 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Warmth | 3.9 units on a scale | Standard Deviation 2.53 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Tingling | 3.3 units on a scale | Standard Deviation 2.5 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Itching | 3.1 units on a scale | Standard Deviation 2.71 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Redness | 3.6 units on a scale | Standard Deviation 2.73 |
| BG00012 | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 3.8 units on a scale | Standard Deviation 2.48 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Warmth | 3.1 units on a scale | Standard Deviation 2.5 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 3.3 units on a scale | Standard Deviation 2.78 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Redness | 2.9 units on a scale | Standard Deviation 2.67 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Tingling | 2.3 units on a scale | Standard Deviation 2.36 |
| BG00012 + ASA | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Itching | 2.3 units on a scale | Standard Deviation 2.52 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Tingling | 2.2 units on a scale | Standard Deviation 1.96 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Redness | 2.9 units on a scale | Standard Deviation 2.3 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Overall flushing | 3.1 units on a scale | Standard Deviation 2.26 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Warmth | 2.9 units on a scale | Standard Deviation 2.15 |
| BG00012 Slow Titration | Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS | Itching | 1.8 units on a scale | Standard Deviation 2.04 |
Comparison: Overall flushing events95% CI: [-1.7, 0.8]
Comparison: Overall flushing events95% CI: [-1.8, 0.4]
Comparison: Redness events95% CI: [-2, 0.6]
Comparison: Redness events95% CI: [-1.9, 0.5]
Comparison: Warmth events95% CI: [-2, 0.4]
Comparison: Warmth events95% CI: [-2.1, 0.2]
Comparison: Tingling events95% CI: [-2.2, 0.1]
Comparison: Tingling events95% CI: [-2.2, 0]
Comparison: Itching events95% CI: [-2.1, 0.4]
Comparison: Itching events95% CI: [-2.4, -0.1]
Secondary
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.
Time frame: Day 1 to Week 8
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | GGT: shift to high; n=44, 41, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to low; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALP: shift to high; n=44, 42, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to low; n=43, 43, 41, 41 | 3 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALT: shift to high; n=44, 42, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to high; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Direct bilirubin: shift to high; n=44, 43, 43, 40 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to low; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to low; n=44, 42, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | AST: shift to high; n=44, 43, 43, 41 | 2 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total bilirubin: shift to high; n=44, 42, 42, 40 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to low; n=44, 43, 43, 41 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to low: n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to high; n=44, 43, 41, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to low; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to high: n=44, 42, 42, 41 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to low; n=44, 41, 43, 41 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to low; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to low; n=44, 43, 43, 42 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Direct bilirubin: shift to high; n=44, 43, 43, 40 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to low; n=44, 42, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALP: shift to high; n=44, 42, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total bilirubin: shift to high; n=44, 42, 42, 40 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to low; n=43, 43, 41, 41 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | AST: shift to high; n=44, 43, 43, 41 | 3 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALT: shift to high; n=44, 42, 43, 42 | 2 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to high; n=44, 43, 41, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to low; n=44, 43, 43, 42 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | GGT: shift to high; n=44, 41, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to low; n=44, 41, 43, 41 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to low; n=44, 43, 43, 41 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to low: n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to high: n=44, 42, 42, 41 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALT: shift to high; n=44, 42, 43, 42 | 5 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | AST: shift to high; n=44, 43, 43, 41 | 4 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | GGT: shift to high; n=44, 41, 43, 42 | 2 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total bilirubin: shift to high; n=44, 42, 42, 40 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to high; n=44, 43, 41, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to low: n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to high: n=44, 42, 42, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to low; n=44, 43, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to low; n=44, 42, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to low; n=43, 43, 41, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALP: shift to high; n=44, 42, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to low; n=44, 43, 43, 41 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Direct bilirubin: shift to high; n=44, 43, 43, 40 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to low; n=44, 41, 43, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to low; n=44, 43, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to high: n=44, 42, 42, 41 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Potassium: shift to low: n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | GGT: shift to high; n=44, 41, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Magnesium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Sodium: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to low; n=44, 43, 43, 41 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Uric Acid: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total protein: shift to low; n=44, 41, 43, 41 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Phosphorus: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Creatinine: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALP: shift to high; n=44, 42, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to high; n=44, 43, 41, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | BUN: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | AST: shift to high; n=44, 43, 43, 41 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Albumin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Total bilirubin: shift to high; n=44, 42, 42, 40 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | LDH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to low; n=43, 43, 41, 41 | 2 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Calcium: shift to low; n=44, 42, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | ALT: shift to high; n=44, 42, 43, 42 | 2 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Bicarbonate: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Direct bilirubin: shift to high; n=44, 43, 43, 40 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Glucose: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry | Chloride: shift to low; n=44, 43, 43, 42 | 0 participants |
Secondary
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute
Time frame: Day 1 to Week 8
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to low; n=43, 43, 43, 41 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to high; n=44, 43, 42, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to low; n=44, 43, 43, 40 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Basophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to low; n=43, 41, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to high; n=44, 41, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to high; n=43, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to low; n=42, 42, 42, 41 | 3 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to low; n=43, 43, 43, 41 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to high; n=44, 43, 43, 42 | 5 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Basophils abs: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to low; n=44, 43, 43, 40 | 2 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to low; n=43, 41, 43, 42 | 3 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to low; n=43, 43, 43, 41 | 5 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to high; n=44, 43, 42, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to low; n=43, 43, 43, 41 | 2 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to high; n=43, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to low; n=44, 43, 43, 42 | 2 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to low; n=42, 42, 42, 41 | 6 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to high; n=44, 41, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to high; n=43, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to low; n=43, 43, 43, 41 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to low; n=42, 42, 42, 41 | 2 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to low; n=43, 43, 43, 41 | 2 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to high; n=44, 43, 42, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to high; n=44, 43, 43, 42 | 6 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Basophils abs: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to low; n=44, 43, 43, 40 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to low; n=43, 41, 43, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to high; n=44, 41, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to high; n=44, 43, 43, 42 | 6 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Eosinophils abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | White blood cells: shift to low; n=43, 43, 43, 41 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Monocytes abs: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to high; n=44, 43, 42, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Lymphocytes abs: shift to low; n=43, 43, 43, 41 | 3 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hematocrit: shift to high; n=43, 43, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to high; n=44, 43, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Neutrophils abs: shift to low; n=42, 42, 42, 41 | 2 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to high; n=44, 41, 43, 42 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Red blood cells: shift to low; n=44, 43, 43, 40 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Platelets: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Hemoglobin: shift to low; n=43, 41, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Hematology | Basophils abs: shift to high; n=44, 43, 43, 42 | 0 participants |
Secondary
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.
Time frame: Day 1 to Week 8
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to high; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Ketones: shift to positive; n=44, 43, 43, 42 | 1 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to high; n=44, 42, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Glucose: shift to positive; n=44, 43, 43, 41 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Blood: shift to positive; n=42, 39, 39, 42 | 3 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to low; n=44, 43, 43, 42 | 0 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic WBC; n=43, 40, 41, 42 | 4 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic RBC; n=44, 40, 40, 41 | 3 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Color: shift to positive; n=41, 43, 41, 39 | 2 participants |
| Placebo | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Protein: shift to positive; n=44, 41, 43, 41 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Color: shift to positive; n=41, 43, 41, 39 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Protein: shift to positive; n=44, 41, 43, 41 | 1 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Glucose: shift to positive; n=44, 43, 43, 41 | 2 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Ketones: shift to positive; n=44, 43, 43, 42 | 7 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic WBC; n=43, 40, 41, 42 | 9 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic RBC; n=44, 40, 40, 41 | 4 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Blood: shift to positive; n=42, 39, 39, 42 | 6 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to high; n=44, 42, 43, 42 | 0 participants |
| BG00012 | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic RBC; n=44, 40, 40, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to high; n=44, 42, 43, 42 | 2 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Blood: shift to positive; n=42, 39, 39, 42 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Color: shift to positive; n=41, 43, 41, 39 | 4 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Glucose: shift to positive; n=44, 43, 43, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Ketones: shift to positive; n=44, 43, 43, 42 | 9 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Protein: shift to positive; n=44, 41, 43, 41 | 1 participants |
| BG00012 + ASA | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic WBC; n=43, 40, 41, 42 | 3 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Color: shift to positive; n=41, 43, 41, 39 | 5 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic WBC; n=43, 40, 41, 42 | 3 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Protein: shift to positive; n=44, 41, 43, 41 | 1 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Blood: shift to positive; n=42, 39, 39, 42 | 2 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to high; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | pH: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Microscopic RBC; n=44, 40, 40, 41 | 2 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to high; n=44, 42, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Specific gravity: shift to low; n=44, 43, 43, 42 | 0 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Ketones: shift to positive; n=44, 43, 43, 42 | 6 participants |
| BG00012 Slow Titration | Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis | Glucose: shift to positive; n=44, 43, 43, 41 | 0 participants |
Secondary
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Time frame: Day 1 to Week 8
Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Constipation; n=6, 8, 13, 11 | 20.49 hours | Standard Deviation 12.04 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Indigestion; n=12, 13, 12, 12 | 4.76 hours | Standard Deviation 8.203 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Flatulence; n=23, 20, 22, 20 | 16.41 hours | Standard Deviation 44.149 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Lower abdominal pain; n=12, 19, 17, 16 | 6.65 hours | Standard Deviation 5.307 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Upper abdominal pain; n=17, 14, 19, 19 | 19.08 hours | Standard Deviation 46.873 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Diarrhea; n=20, 20 17, 15 | 5.57 hours | Standard Deviation 10.037 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Bloating; n=14, 14, 21, 12 | 9.50 hours | Standard Deviation 9.066 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Vomiting; n=3, 3, 3, 2 | 5.87 hours | Standard Deviation 5.033 |
| Placebo | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Nausea; n=12, 21, 21, 22 | 9.74 hours | Standard Deviation 17.008 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Vomiting; n=3, 3, 3, 2 | 10.08 hours | Standard Deviation 8.755 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Constipation; n=6, 8, 13, 11 | 28.20 hours | Standard Deviation 35.425 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Indigestion; n=12, 13, 12, 12 | 16.49 hours | Standard Deviation 28.865 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Diarrhea; n=20, 20 17, 15 | 2.92 hours | Standard Deviation 3.329 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Nausea; n=12, 21, 21, 22 | 7.05 hours | Standard Deviation 10.498 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Upper abdominal pain; n=17, 14, 19, 19 | 6.67 hours | Standard Deviation 16.916 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Flatulence; n=23, 20, 22, 20 | 9.06 hours | Standard Deviation 9.626 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Bloating; n=14, 14, 21, 12 | 16.91 hours | Standard Deviation 27.128 |
| BG00012 | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Lower abdominal pain; n=12, 19, 17, 16 | 13.93 hours | Standard Deviation 26.85 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Vomiting; n=3, 3, 3, 2 | 1.88 hours | Standard Deviation 2.717 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Nausea; n=12, 21, 21, 22 | 10.01 hours | Standard Deviation 18.283 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Diarrhea; n=20, 20 17, 15 | 14.66 hours | Standard Deviation 32.686 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Upper abdominal pain; n=17, 14, 19, 19 | 15.88 hours | Standard Deviation 25.307 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Lower abdominal pain; n=12, 19, 17, 16 | 10.84 hours | Standard Deviation 16.312 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Indigestion; n=12, 13, 12, 12 | 3.80 hours | Standard Deviation 2.543 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Constipation; n=6, 8, 13, 11 | 14.26 hours | Standard Deviation 9.783 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Bloating; n=14, 14, 21, 12 | 9.68 hours | Standard Deviation 10.108 |
| BG00012 + ASA | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Flatulence; n=23, 20, 22, 20 | 68.93 hours | Standard Deviation 290.248 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Constipation; n=6, 8, 13, 11 | 20.90 hours | Standard Deviation 18.06 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Lower abdominal pain; n=12, 19, 17, 16 | 7.75 hours | Standard Deviation 10.456 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Upper abdominal pain; n=17, 14, 19, 19 | 3.83 hours | Standard Deviation 5.712 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Flatulence; n=23, 20, 22, 20 | 63.84 hours | Standard Deviation 180.597 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Bloating; n=14, 14, 21, 12 | 77.24 hours | Standard Deviation 125.961 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Diarrhea; n=20, 20 17, 15 | 4.97 hours | Standard Deviation 9.687 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Indigestion; n=12, 13, 12, 12 | 4.91 hours | Standard Deviation 8.263 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Vomiting; n=3, 3, 3, 2 | 0.75 hours | Standard Deviation 0.707 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS | Nausea; n=12, 21, 21, 22 | 2.98 hours | Standard Deviation 3.247 |
Comparison: Nausea95% CI: [-6.34, 12.26]
Comparison: Nausea95% CI: [-8.81, 0.67]
Comparison: Diarrhea95% CI: [-3.15, 26.63]
Comparison: Diarrhea95% CI: [-2.67, 6.77]
Comparison: Upper abdominal pain95% CI: [-6.72, 25.14]
Comparison: Upper abdominal pain95% CI: [-11.31, 5.63]
Comparison: Lower abdominal pain95% CI: [-18.36, 12.19]
Comparison: Lower abdominal pain95% CI: [-20.71, 8.35]
Comparison: Vomiting95% CI: [-22.9, 6.49]
Comparison: Vomiting95% CI: [-30.13, 11.47]
Comparison: Indigestion95% CI: [-30.02, 4.63]
Comparison: Indigestion95% CI: [-29.48, 6.32]
Comparison: Constipation95% CI: [-35.44, 7.57]
Comparison: Constipation95% CI: [-33.39, 18.81]
Comparison: Bloating95% CI: [-20.4, 5.93]
Comparison: Bloating95% CI: [-10.78, 131.4]
Comparison: Flatulence95% CI: [-71.51, 191.2]
Comparison: Flatulence95% CI: [-27.09, 136.6]
Secondary
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Time frame: Week 1 to Week 4
Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Constipation; n=4, 8, 11, 11 | 17.05 hours | Standard Deviation 7.452 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Indigestion; n=11, 11, 9, 11 | 5.08 hours | Standard Deviation 8.552 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Flatulence; n=21, 17, 22, 19 | 12.83 hours | Standard Deviation 27.948 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Lower abdominal pain; n=9, 18, 14, 13 | 5.40 hours | Standard Deviation 4.658 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Upper abdominal pain; n=14, 14, 17, 15 | 21.37 hours | Standard Deviation 51.62 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Diarrhea; n=13, 20, 14, 14 | 5.20 hours | Standard Deviation 11.309 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Bloating; n=9, 14, 19, 11 | 6.70 hours | Standard Deviation 6.792 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Vomiting; n=2, 2, 2, 2 | 4.31 hours | Standard Deviation 5.999 |
| Placebo | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Nausea; n=10, 18, 18, 20 | 10.47 hours | Standard Deviation 18.678 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Vomiting; n=2, 2, 2, 2 | 5.63 hours | Standard Deviation 5.834 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Constipation; n=4, 8, 11, 11 | 27.61 hours | Standard Deviation 35.177 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Indigestion; n=11, 11, 9, 11 | 29.00 hours | Standard Deviation 48.416 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Diarrhea; n=13, 20, 14, 14 | 2.53 hours | Standard Deviation 3.013 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Nausea; n=10, 18, 18, 20 | 7.23 hours | Standard Deviation 10.916 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Upper abdominal pain; n=14, 14, 17, 15 | 6.81 hours | Standard Deviation 16.876 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Flatulence; n=21, 17, 22, 19 | 9.34 hours | Standard Deviation 12.946 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Bloating; n=9, 14, 19, 11 | 13.81 hours | Standard Deviation 25.321 |
| BG00012 | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Lower abdominal pain; n=9, 18, 14, 13 | 14.20 hours | Standard Deviation 27.637 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Vomiting; n=2, 2, 2, 2 | 2.53 hours | Standard Deviation 3.5 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Nausea; n=10, 18, 18, 20 | 11.18 hours | Standard Deviation 19.568 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Diarrhea; n=13, 20, 14, 14 | 16.04 hours | Standard Deviation 35.945 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Upper abdominal pain; n=14, 14, 17, 15 | 17.65 hours | Standard Deviation 26.294 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Lower abdominal pain; n=9, 18, 14, 13 | 12.51 hours | Standard Deviation 17.621 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Indigestion; n=11, 11, 9, 11 | 3.93 hours | Standard Deviation 2.873 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Constipation; n=4, 8, 11, 11 | 15.12 hours | Standard Deviation 7.761 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Bloating; n=9, 14, 19, 11 | 11.07 hours | Standard Deviation 10.631 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Flatulence; n=21, 17, 22, 19 | 35.86 hours | Standard Deviation 134.748 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Constipation; n=4, 8, 11, 11 | 21.28 hours | Standard Deviation 19.298 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Lower abdominal pain; n=9, 18, 14, 13 | 6.30 hours | Standard Deviation 6.08 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Upper abdominal pain; n=14, 14, 17, 15 | 4.31 hours | Standard Deviation 6.35 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Flatulence; n=21, 17, 22, 19 | 61.13 hours | Standard Deviation 168.572 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Bloating; n=9, 14, 19, 11 | 95.69 hours | Standard Deviation 186.884 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Diarrhea; n=13, 20, 14, 14 | 4.97 hours | Standard Deviation 10.074 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Indigestion; n=11, 11, 9, 11 | 5.05 hours | Standard Deviation 8.665 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Vomiting; n=2, 2, 2, 2 | 0.75 hours | Standard Deviation 0.707 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS | Nausea; n=10, 18, 18, 20 | 2.86 hours | Standard Deviation 3.359 |
Comparison: Nausea95% CI: [-6.79, 14.68]
Comparison: Nausea95% CI: [-9.57, 0.83]
Comparison: Diarrhea95% CI: [-2.84, 29.86]
Comparison: Diarrhea95% CI: [-2.41, 7.29]
Comparison: Upper abdominal pain95% CI: [-5.81, 27.5]
Comparison: Upper abdominal pain95% CI: [-12.08, 7.09]
Comparison: Lower abdominal pain95% CI: [-19.03, 15.64]
Comparison: Lower abdominal pain95% CI: [-23.93, 8.11]
Comparison: Vomiting95% CI: [-23.8, 17.6]
Comparison: Vomiting95% CI: [-22.75, 13]
Comparison: Indigestion95% CI: [-59.2, 9.05]
Comparison: Indigestion95% CI: [-54.89, 6.98]
Comparison: Constipation95% CI: [-35.38, 10.39]
Comparison: Constipation95% CI: [-32.79, 20.13]
Comparison: Bloating95% CI: [-15.87, 10.41]
Comparison: Bloating95% CI: [-22.04, 185.8]
Comparison: Flatulence95% CI: [-40.13, 93.18]
Comparison: Flatulence95% CI: [-31.65, 135.2]
Secondary
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Time frame: Week 5 to Week 8
Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Vomiting; n=1, 1, 1, 0 | 9.00 hours | — |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Indigestion; n=6, 7, 7, 5 | 2.43 hours | Standard Deviation 1.569 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Diarrhea; n=12, 13, 6, 8 | 4.50 hours | Standard Deviation 6.389 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Constipation; n=5, 2, 4, 4 | 23.35 hours | Standard Deviation 17.11 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Flatulence; n=9, 13, 7, 10 | 44.67 hours | Standard Deviation 112.426 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Upper abdominal pain; n=6, 5, 5, 5 | 5.29 hours | Standard Deviation 5.785 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Nausea; n=4, 9, 6, 9 | 3.96 hours | Standard Deviation 3.668 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Lower abdominal pain; n=7, 5, 5, 9 | 6.63 hours | Standard Deviation 7.739 |
| Placebo | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Bloating; n=7, 8, 7, 8 | 12.49 hours | Standard Deviation 10.595 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Lower abdominal pain; n=7, 5, 5, 9 | 3.98 hours | Standard Deviation 3.516 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Constipation; n=5, 2, 4, 4 | 15.47 hours | Standard Deviation 21.143 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Upper abdominal pain; n=6, 5, 5, 5 | 1.12 hours | Standard Deviation 0.965 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Indigestion; n=6, 7, 7, 5 | 2.57 hours | Standard Deviation 2.586 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Flatulence; n=9, 13, 7, 10 | 7.21 hours | Standard Deviation 10.051 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Bloating; n=7, 8, 7, 8 | 18.52 hours | Standard Deviation 25.682 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Diarrhea; n=12, 13, 6, 8 | 6.62 hours | Standard Deviation 12.782 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Nausea; n=4, 9, 6, 9 | 4.34 hours | Standard Deviation 6.256 |
| BG00012 | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Vomiting; n=1, 1, 1, 0 | 19.00 hours | — |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Vomiting; n=1, 1, 1, 0 | 0.58 hours | — |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Nausea; n=4, 9, 6, 9 | 2.66 hours | Standard Deviation 1.39 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Diarrhea; n=12, 13, 6, 8 | 7.05 hours | Standard Deviation 8.002 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Upper abdominal pain; n=6, 5, 5, 5 | 1.86 hours | Standard Deviation 1.491 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Lower abdominal pain; n=7, 5, 5, 9 | 2.84 hours | Standard Deviation 1.477 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Indigestion; n=6, 7, 7, 5 | 5.02 hours | Standard Deviation 6.944 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Constipation; n=5, 2, 4, 4 | 21.30 hours | Standard Deviation 23.181 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Bloating; n=7, 8, 7, 8 | 4.16 hours | Standard Deviation 3.018 |
| BG00012 + ASA | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Flatulence; n=9, 13, 7, 10 | 105.86 hours | Standard Deviation 275.125 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Constipation; n=5, 2, 4, 4 | 18.24 hours | Standard Deviation 8.644 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Lower abdominal pain; n=7, 5, 5, 9 | 22.54 hours | Standard Deviation 61.18 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Upper abdominal pain; n=6, 5, 5, 5 | 1.73 hours | Standard Deviation 1.44 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Flatulence; n=9, 13, 7, 10 | 18.48 hours | Standard Deviation 26.347 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Bloating; n=7, 8, 7, 8 | 85.64 hours | Standard Deviation 115.872 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Diarrhea; n=12, 13, 6, 8 | 2.14 hours | Standard Deviation 2.007 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Indigestion; n=6, 7, 7, 5 | 1.63 hours | Standard Deviation 1.101 |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Vomiting; n=1, 1, 1, 0 | NA hours | — |
| BG00012 Slow Titration | Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS | Nausea; n=4, 9, 6, 9 | 2.34 hours | Standard Deviation 1.904 |
Comparison: Nausea95% CI: [-7.35, 3.99]
Comparison: Nausea95% CI: [-6.62, 2.62]
Comparison: Diarrhea95% CI: [-11.64, 12.49]
Comparison: Diarrhea95% CI: [-14.11, 5.14]
Comparison: Upper abdominal pain95% CI: [-1.1, 2.57]
Comparison: Upper abdominal pain95% CI: [-1.17, 2.4]
Comparison: Lower abdominal pain95% CI: [-5.08, 2.79]
Comparison: Lower abdominal pain95% CI: [-42.19, 79.32]
Comparison: Indigestion95% CI: [-3.65, 8.56]
Comparison: Indigestion95% CI: [-3.71, 1.83]
Comparison: Constipation95% CI: [-48.73, 60.38]
Comparison: Constipation95% CI: [-28.38, 33.91]
Comparison: Bloating95% CI: [-35.56, 6.83]
Comparison: Bloating95% CI: [-22.88, 157.1]
Comparison: Flatulence95% CI: [-58.01, 255.3]
Comparison: Flatulence95% CI: [-5.22, 27.76]
Secondary
Duration of Flushing Events During the Overall Treatment Period, Based on MFSS
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Time frame: Day 1 to Week 8
Population: Participants with a flushing event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Flushing Events During the Overall Treatment Period, Based on MFSS | 98.4 minutes | Standard Deviation 92.04 |
| BG00012 | Duration of Flushing Events During the Overall Treatment Period, Based on MFSS | 63.2 minutes | Standard Deviation 34.55 |
| BG00012 + ASA | Duration of Flushing Events During the Overall Treatment Period, Based on MFSS | 69.8 minutes | Standard Deviation 78.09 |
| BG00012 Slow Titration | Duration of Flushing Events During the Overall Treatment Period, Based on MFSS | 68.9 minutes | Standard Deviation 52.82 |
95% CI: [-20.9, 34.1]
95% CI: [-14.2, 25.7]
Secondary
Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Time frame: Week 1 to Week 4
Population: Participants with a flushing event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS | 117.6 minutes | Standard Deviation 143.9 |
| BG00012 | Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS | 67.6 minutes | Standard Deviation 43.83 |
| BG00012 + ASA | Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS | 89.8 minutes | Standard Deviation 140.67 |
| BG00012 Slow Titration | Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS | 69.2 minutes | Standard Deviation 53 |
95% CI: [-26.5, 70.9]
95% CI: [-20.5, 23.6]
Secondary
Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Time frame: Week 5 to Week 8
Population: Participants with a flushing event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS | 113.2 minutes | Standard Deviation 160.82 |
| BG00012 | Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS | 55.7 minutes | Standard Deviation 32.37 |
| BG00012 + ASA | Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS | 73.2 minutes | Standard Deviation 66.34 |
| BG00012 Slow Titration | Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS | 56.0 minutes | Standard Deviation 35.79 |
95% CI: [-9.2, 44.2]
95% CI: [-17.2, 18]
Secondary
Number of Participants With Abnormalities in Vital Signs
↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute
Time frame: Day 1 to Week 8
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormalities in Vital Signs | Pulse >120 bpm or ↑ from BL of >20 bpm | 8 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | SBP >180 mm Hg or ↑ from BL of >40 mm Hg | 1 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | Respiration rate >25 b/m or ↑ from BL of ≥50% | 1 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | DBP <50 mm Hg or ↓ from BL of >20 mm Hg | 1 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | DBP >105 mm Hg or ↑ from BL of >30 mm Hg | 0 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | Temperature >38°C + ↑ from BL of ≥1°C | 0 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | Respiration rate 10 b/m or ↓ from BL of ≥50% | 0 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | SBP <90 mm Hg or ↓ from BL of >30 mm Hg | 1 participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs | Pulse <50 bpm or ↓ from BL of >20 bpm | 11 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | SBP <90 mm Hg or ↓ from BL of >30 mm Hg | 2 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | DBP >105 mm Hg or ↑ from BL of >30 mm Hg | 0 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | Respiration rate >25 b/m or ↑ from BL of ≥50% | 2 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | Pulse >120 bpm or ↑ from BL of >20 bpm | 10 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | DBP <50 mm Hg or ↓ from BL of >20 mm Hg | 3 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | Pulse <50 bpm or ↓ from BL of >20 bpm | 4 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | Temperature >38°C + ↑ from BL of ≥1°C | 0 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | SBP >180 mm Hg or ↑ from BL of >40 mm Hg | 0 participants |
| BG00012 | Number of Participants With Abnormalities in Vital Signs | Respiration rate 10 b/m or ↓ from BL of ≥50% | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | DBP <50 mm Hg or ↓ from BL of >20 mm Hg | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | Respiration rate >25 b/m or ↑ from BL of ≥50% | 3 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | Respiration rate 10 b/m or ↓ from BL of ≥50% | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | Pulse <50 bpm or ↓ from BL of >20 bpm | 3 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | SBP >180 mm Hg or ↑ from BL of >40 mm Hg | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | Temperature >38°C + ↑ from BL of ≥1°C | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | SBP <90 mm Hg or ↓ from BL of >30 mm Hg | 1 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | DBP >105 mm Hg or ↑ from BL of >30 mm Hg | 0 participants |
| BG00012 + ASA | Number of Participants With Abnormalities in Vital Signs | Pulse >120 bpm or ↑ from BL of >20 bpm | 20 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | Respiration rate 10 b/m or ↓ from BL of ≥50% | 0 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | Pulse >120 bpm or ↑ from BL of >20 bpm | 17 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | Pulse <50 bpm or ↓ from BL of >20 bpm | 4 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | SBP >180 mm Hg or ↑ from BL of >40 mm Hg | 0 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | SBP <90 mm Hg or ↓ from BL of >30 mm Hg | 1 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | DBP >105 mm Hg or ↑ from BL of >30 mm Hg | 0 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | DBP <50 mm Hg or ↓ from BL of >20 mm Hg | 1 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | Respiration rate >25 b/m or ↑ from BL of ≥50% | 3 participants |
| BG00012 Slow Titration | Number of Participants With Abnormalities in Vital Signs | Temperature >38°C + ↑ from BL of ≥1°C | 0 participants |
Secondary
Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results
Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'
Time frame: Day 1 to Week 8
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, not adverse event | 2 participants |
| Placebo | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, adverse event | 0 participants |
| BG00012 | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, adverse event | 0 participants |
| BG00012 | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, not adverse event | 3 participants |
| BG00012 + ASA | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, not adverse event | 2 participants |
| BG00012 + ASA | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, adverse event | 0 participants |
| BG00012 Slow Titration | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, not adverse event | 4 participants |
| BG00012 Slow Titration | Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results | Shift to abnormal, adverse event | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.
Time frame: Day 1 up to end of Safety Follow-up (9 weeks)
Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Any event | 24 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Discontinuation of treatment due to an event | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Serious event | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Moderate or severe event | 10 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Withdrawal from study due to an event | 2 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Severe event | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Related event | 8 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Discontinuation of treatment due to an event | 4 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Related event | 17 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Severe event | 4 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Serious event | 1 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Withdrawal from study due to an event | 4 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Moderate or severe event | 13 participants |
| BG00012 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Any event | 24 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Related event | 16 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Any event | 26 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Moderate or severe event | 12 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Severe event | 4 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Serious event | 0 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Discontinuation of treatment due to an event | 6 participants |
| BG00012 + ASA | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Withdrawal from study due to an event | 6 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Severe event | 1 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Withdrawal from study due to an event | 3 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Discontinuation of treatment due to an event | 3 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Moderate or severe event | 11 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Any event | 26 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Serious event | 0 participants |
| BG00012 Slow Titration | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs) | Related event | 18 participants |