Trial Outcomes & Findings for Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease (NCT NCT02743806)
NCT ID: NCT02743806
Last Updated: 2023-11-18
Results Overview
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
331 participants
Primary outcome timeframe
From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Results posted on
2023-11-18
Participant Flow
Participants took part in the study at 78 investigative sites in Australia, Bulgaria, the Czech Republic, Estonia, Hungary, India, Italy, Republic of Korea, Latvia, Malaysia, New Zealand, Poland, Romania, Russian Federation, Serbia, South Africa, Turkey, and Ukraine from 01 August 2016 to 03 January 2023.
A total of 331 participants with a diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) who have successfully completed the participation in qualifying vedolizumab clinical studies (C13008 \[NCT00790933\] and MLN0002-3028 \[NCT02425111\]) were enrolled in this extended access program (XAP) study to receive vedolizumab 300 mg.
Participant milestones
| Measure |
Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Overall Study
STARTED
|
331
|
|
Overall Study
COMPLETED
|
150
|
|
Overall Study
NOT COMPLETED
|
181
|
Reasons for withdrawal
| Measure |
Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Voluntary Withdrawal
|
54
|
|
Overall Study
Study Termination
|
65
|
|
Overall Study
Pregnancy
|
6
|
|
Overall Study
No Longer Clinically Benefiting
|
27
|
|
Overall Study
Reason Not Specified
|
12
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 mg
n=331 Participants
Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.29 • n=331 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=331 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=331 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=331 Participants
|
|
Race (NIH/OMB)
White
|
292 Participants
n=331 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=331 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=331 Participants
|
|
Region of Enrollment
Australia
|
13 Participants
n=331 Participants
|
|
Region of Enrollment
Bulgaria
|
4 Participants
n=331 Participants
|
|
Region of Enrollment
Czech Republic
|
115 Participants
n=331 Participants
|
|
Region of Enrollment
Estonia
|
4 Participants
n=331 Participants
|
|
Region of Enrollment
Hungary
|
46 Participants
n=331 Participants
|
|
Region of Enrollment
India
|
13 Participants
n=331 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=331 Participants
|
|
Region of Enrollment
Korea, Republic of
|
21 Participants
n=331 Participants
|
|
Region of Enrollment
Latvia
|
1 Participants
n=331 Participants
|
|
Region of Enrollment
Malaysia
|
1 Participants
n=331 Participants
|
|
Region of Enrollment
New Zealand
|
6 Participants
n=331 Participants
|
|
Region of Enrollment
Poland
|
41 Participants
n=331 Participants
|
|
Region of Enrollment
Romania
|
3 Participants
n=331 Participants
|
|
Region of Enrollment
Russian Federation
|
35 Participants
n=331 Participants
|
|
Region of Enrollment
Serbia
|
1 Participants
n=331 Participants
|
|
Region of Enrollment
Turkey
|
5 Participants
n=331 Participants
|
|
Region of Enrollment
Ukraine
|
5 Participants
n=331 Participants
|
|
Region of Enrollment
South Africa
|
12 Participants
n=331 Participants
|
|
Weight
|
76.91 kilograms (kg)
STANDARD_DEVIATION 16.988 • n=330 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
|
Height
|
171.4 centimeters (cm)
STANDARD_DEVIATION 11.06 • n=330 Participants • Number analyzed is the number of participants with data available for height at Baseline.
|
|
Body Mass Index (BMI)
|
26.16 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.667 • n=330 Participants • Number analyzed is the number of participants with data available for BMI at Baseline.
|
PRIMARY outcome
Timeframe: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)Population: FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=331 Participants
Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
61.9 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
15.1 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)Population: FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy \[PML\]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=331 Participants
Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
|
3.9 percentage of participants
|
Adverse Events
Vedolizumab 300 mg
Serious events: 50 serious events
Other events: 100 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vedolizumab 300 mg
n=331 participants at risk
Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Nervous system disorders
Intracranial aneurysm
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.60%
2/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
Abdominal abscess
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Investigations
Amylase increased
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
Anal abscess
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Anal fistula
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
COVID-19
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Eye disorders
Cataract
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.8%
4/142 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Crohn's disease
|
2.6%
5/189 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Product Issues
Device dislocation
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Nervous system disorders
Dizziness
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Endocrine disorders
Goitre
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Vascular disorders
Hypertension
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
2/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Nausea
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
2/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Vascular disorders
Peripheral artery dissection
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
Pneumonia
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Pseudopolyposis
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Subileus
|
0.60%
2/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Vascular disorders
Venous aneurysm
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
Other adverse events
| Measure |
Vedolizumab 300 mg
n=331 participants at risk
Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.
|
|---|---|
|
Infections and infestations
COVID-19
|
5.1%
17/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
14.1%
20/142 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Gastrointestinal disorders
Crohn's disease
|
18.5%
35/189 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Vascular disorders
Hypertension
|
6.3%
21/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
22/331 • From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER