Trial Outcomes & Findings for A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease (NCT NCT02620046)
NCT ID: NCT02620046
Last Updated: 2025-04-03
Results Overview
A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
746 participants
Primary outcome timeframe
Up to 97.9 months
Results posted on
2025-04-03
Participant Flow
Participants took part in the study at various investigative sites globally from 15 April 2016 to 12 June 2024.
Participants who had previously participated in Study MLN0002SC-3027 \[NCT02611830\] or MLN0002SC-3031 \[NCT02611817\] and were eligible to participate received vedolizumab subcutaneously (SC) \[either 108 milligrams (mg) once every two weeks (Q2W) or once per week (QW)\] in the disease groups of Ulcerative Colitis and Crohn's Disease in this study. Data is presented accordingly.
Participant milestones
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
Participants with ulcerative colitis (UC) who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with Crohn's disease (CD) who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
458
|
|
Overall Study
COMPLETED
|
125
|
162
|
|
Overall Study
NOT COMPLETED
|
163
|
296
|
Reasons for withdrawal
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
Participants with ulcerative colitis (UC) who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with Crohn's disease (CD) who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
42
|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
|
Overall Study
Withdrawal by Subject
|
36
|
66
|
|
Overall Study
Site Termination
|
3
|
3
|
|
Overall Study
Pregnancy
|
3
|
7
|
|
Overall Study
Lack of Efficacy
|
81
|
146
|
|
Overall Study
Leukopenia or Lymphopenia
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
13
|
21
|
|
Overall Study
Significant Protocol Deviation
|
0
|
1
|
Baseline Characteristics
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
Baseline characteristics by cohort
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=288 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
n=458 Participants
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
265 Participants
n=5 Participants
|
440 Participants
n=7 Participants
|
705 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
253 Participants
n=5 Participants
|
361 Participants
n=7 Participants
|
614 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
226 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
643 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 97.9 monthsPopulation: The SAF included all participants who had received at least 1 dose of study medication during this study (MLN0002SC-3030).
A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=288 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
n=458 Participants
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
TEAEs
|
22.9 events per 100 participant years
|
28.0 events per 100 participant years
|
|
Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Serious TEAEs
|
6.5 events per 100 participant years
|
8.7 events per 100 participant years
|
SECONDARY outcome
Timeframe: Up to 97.9 monthsPopulation: The SAF included all participants who had received at least 1 dose of study medication during this study (MLN0002SC-3030).
AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=288 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
n=458 Participants
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
|
16.3 events per 100 participant years
|
17.4 events per 100 participant years
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set (FAS) included all enrolled participants of this study MLN0002SC-3030. Overall number of participants analyzed is the number of participants with data available for analyses.
Clinical response is defined as a decrease in the partial Mayo score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=288 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48
|
168 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: FAS included all enrolled participants of this study MLN0002SC-3030. Overall number analyzed is the number of randomized CD participants withdrawn from the parent study between Week 6 and Week 52.
Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only \[defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52\]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=114 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: FAS included all enrolled participants of this study MLN0002SC-3030.
Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore \>1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=288 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score
|
150 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: FAS included all enrolled participants of this study MLN0002SC-3030.
Clinical remission is defined as total HBI score of ≤4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.
Outcome measures
| Measure |
Ulcerative Colitis: Vedolizumab 108 mg
n=458 Participants
Participants with UC who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
Crohn's Disease: Vedolizumab 108 mg
Participants with CD who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas participants who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
|
|---|---|---|
|
Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores
|
217 Participants
|
—
|
Adverse Events
Ulcerative Colitis: Only Vedolizumab Q2W
Serious events: 29 serious events
Other events: 94 other events
Deaths: 3 deaths
Ulcerative Colitis: Only Vedolizumab QW
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Ulcerative Colitis: Vedolizumab Dose Escalation From Q2W to QW
Serious events: 24 serious events
Other events: 55 other events
Deaths: 0 deaths
Crohn's Disease: Only Vedolizumab Q2W
Serious events: 55 serious events
Other events: 151 other events
Deaths: 2 deaths
Crohn's Disease: Only Vedolizumab QW
Serious events: 35 serious events
Other events: 78 other events
Deaths: 0 deaths
Crohn's Disease: Vedolizumab Dose Escalation From Q2W to QW
Serious events: 31 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ulcerative Colitis: Only Vedolizumab Q2W
n=163 participants at risk
Participants with UC who received vedolizumab SC 108 mg Q2W in this study were included in this arm group.
|
Ulcerative Colitis: Only Vedolizumab QW
n=60 participants at risk
Participants with UC who received vedolizumab SC 108 mg QW in this study were included in this arm group.
|
Ulcerative Colitis: Vedolizumab Dose Escalation From Q2W to QW
n=65 participants at risk
Participants with UC who experienced treatment failure (i.e., disease worsening or need for rescue medications) while receiving vedolizumab 108 mg Q2W during this study and underwent dose escalation to receive vedolizumab SC 108 mg QW were included in this arm group.
|
Crohn's Disease: Only Vedolizumab Q2W
n=239 participants at risk
Participants with CD who received vedolizumab SC 108 mg Q2W in this study were included in this arm group.
|
Crohn's Disease: Only Vedolizumab QW
n=117 participants at risk
Participants with CD who received vedolizumab SC 108 mg QW in this study were included in this arm group.
|
Crohn's Disease: Vedolizumab Dose Escalation From Q2W to QW
n=102 participants at risk
Participants with CD who experienced treatment failure (i.e., disease worsening or need for rescue medications) while receiving vedolizumab 108 mg Q2W during this study and underwent dose escalation to receive vedolizumab SC 108 mg QW were included in this arm group.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.1%
2/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
3/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
9.2%
6/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.6%
3/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.84%
2/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Angina pectoris
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Appendiceal abscess
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Appendicitis
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
COVID-19
|
1.2%
2/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
4/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.5%
4/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
11.7%
7/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
16.9%
11/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
4/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.5%
10/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
13.7%
14/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Vascular disorders
Deep vein thrombosis
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Diverticulitis
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/61 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/27 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/32 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.94%
1/106 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/63 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/45 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Investigations
Fibrin D dimer increased
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Gastrointestinal organ contusion
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Headache
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Ileal ulcer perforation
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Influenza
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/61 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/27 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/32 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.94%
1/106 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/63 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/45 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Intestinal fibrosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.84%
2/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Ischaemic stroke
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Liver contusion
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage II
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.1%
2/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Orchitis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Endocrine disorders
Parathyroid disorder
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Peritonitis
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.9%
3/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.75%
1/133 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/54 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/57 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.75%
1/133 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/54 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/57 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pneumatocele
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Pyelonephritis acute
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/33 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.75%
1/133 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/54 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/57 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Sepsis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.1%
5/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Subileus
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Syncope
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Tooth abscess
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.42%
1/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.6%
1/61 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/27 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/32 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/106 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/63 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.2%
1/45 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Injury, poisoning and procedural complications
Wound
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
Other adverse events
| Measure |
Ulcerative Colitis: Only Vedolizumab Q2W
n=163 participants at risk
Participants with UC who received vedolizumab SC 108 mg Q2W in this study were included in this arm group.
|
Ulcerative Colitis: Only Vedolizumab QW
n=60 participants at risk
Participants with UC who received vedolizumab SC 108 mg QW in this study were included in this arm group.
|
Ulcerative Colitis: Vedolizumab Dose Escalation From Q2W to QW
n=65 participants at risk
Participants with UC who experienced treatment failure (i.e., disease worsening or need for rescue medications) while receiving vedolizumab 108 mg Q2W during this study and underwent dose escalation to receive vedolizumab SC 108 mg QW were included in this arm group.
|
Crohn's Disease: Only Vedolizumab Q2W
n=239 participants at risk
Participants with CD who received vedolizumab SC 108 mg Q2W in this study were included in this arm group.
|
Crohn's Disease: Only Vedolizumab QW
n=117 participants at risk
Participants with CD who received vedolizumab SC 108 mg QW in this study were included in this arm group.
|
Crohn's Disease: Vedolizumab Dose Escalation From Q2W to QW
n=102 participants at risk
Participants with CD who experienced treatment failure (i.e., disease worsening or need for rescue medications) while receiving vedolizumab 108 mg Q2W during this study and underwent dose escalation to receive vedolizumab SC 108 mg QW were included in this arm group.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
3/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.1%
2/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
13.8%
33/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
17.1%
20/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
14.7%
15/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
2/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.2%
10/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.6%
3/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.9%
7/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
3/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.3%
5/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
13.8%
9/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.9%
14/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.6%
3/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.9%
6/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.1%
5/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.0%
7/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.9%
4/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
3/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.7%
5/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
14.2%
34/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
12.0%
14/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.8%
11/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
9/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.3%
2/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.6%
3/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.9%
14/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.4%
4/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.8%
9/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.7%
4/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.4%
13/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.9%
5/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Bronchitis
|
5.5%
9/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
9.2%
6/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.7%
16/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.8%
8/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.8%
8/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
COVID-19
|
14.7%
24/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.3%
2/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.7%
5/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
12.1%
29/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.4%
4/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.8%
9/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
23.3%
14/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
50.8%
33/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
12/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.2%
10/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.8%
8/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.9%
26/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
25.6%
30/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
52.0%
53/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
12/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.3%
2/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
12.3%
8/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.5%
18/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.3%
12/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
9.8%
10/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
General disorders
Fatigue
|
3.7%
6/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.4%
13/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.3%
5/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.9%
5/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
4/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.7%
4/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.1%
2/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.6%
11/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.1%
6/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.9%
4/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
3/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.9%
6/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Nervous system disorders
Headache
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
3/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.8%
7/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.9%
19/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.3%
5/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
13.7%
14/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Herpes zoster
|
2.5%
4/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.84%
2/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.3%
5/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Vascular disorders
Hypertension
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
12/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.6%
3/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.9%
5/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Influenza
|
2.5%
4/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
3/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.8%
7/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
12/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.3%
5/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.9%
3/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
General disorders
Injection site erythema
|
1.2%
2/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.3%
5/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
2/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.98%
1/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
General disorders
Injection site reaction
|
1.2%
2/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.7%
4/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.84%
2/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.00%
0/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.61%
1/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.3%
5/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.9%
3/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Nasopharyngitis
|
14.1%
23/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
18.3%
11/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
23.1%
15/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.9%
26/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
13.7%
16/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
19.6%
20/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
7/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.6%
3/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.9%
14/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.0%
7/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
12.7%
13/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Pharyngitis
|
4.3%
7/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.5%
6/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.1%
6/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.9%
3/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Pneumonia
|
1.8%
3/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.3%
3/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
0.85%
1/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
2.0%
2/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
General disorders
Pyrexia
|
3.1%
5/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.7%
4/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.6%
3/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
12/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.7%
9/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
9.8%
10/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Sinusitis
|
5.5%
9/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.3%
2/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
6.2%
4/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
12/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.1%
6/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.8%
8/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.2%
28/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.0%
6/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
10.8%
7/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
15.9%
38/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
11.1%
13/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
17.6%
18/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
8/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.3%
2/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.5%
1/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.0%
12/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
4.3%
5/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
8.8%
9/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
4/163 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
1.7%
1/60 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.1%
2/65 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
5.4%
13/239 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
3.4%
4/117 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
7.8%
8/102 • Up to 97.9 months
The SAF included all participants who had received at least 1 dose of study medication in this study (MLN0002SC-3030). Adverse events and All-cause mortality are presented as per the dosing regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place