Trial Outcomes & Findings for Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis] (NCT NCT03824561)
NCT ID: NCT03824561
Last Updated: 2025-09-11
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Recruitment status
COMPLETED
Target enrollment
1110 participants
Primary outcome timeframe
Up to Week 54
Results posted on
2025-09-11
Participant Flow
Participants took part in the study at 197 investigative sites in Japan, from 1 February 2019 to 12 February 2025.
Participants with ulcerative colitis who received Vedolizumab IV infusion 300 mg were enrolled. Participants received Vedolizumab IV infusion 300 mg as part of a routine normal practice.
Participant milestones
| Measure |
Vedolizumab 300 mg
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Overall Study
STARTED
|
1110
|
|
Overall Study
COMPLETED
|
1091
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Vedolizumab 300 mg
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
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|---|---|
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Overall Study
Protocol Violation
|
19
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 mg
n=1091 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 17.45 • n=1091 Participants
|
|
Sex: Female, Male
Female
|
470 Participants
n=1091 Participants
|
|
Sex: Female, Male
Male
|
621 Participants
n=1091 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=1091 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Number of Participants Who Experienced at Least One Adverse Events (AEs)
|
208 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=1091 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Number of Participants Who Experienced at Least One Adverse Drug Reactions
|
60 Participants
|
SECONDARY outcome
Timeframe: Week 54Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=1062 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
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|---|---|
|
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
With Presence
|
904 Participants
|
|
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
With Absence
|
158 Participants
|
SECONDARY outcome
Timeframe: Week 54Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=1062 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
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Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Continued Participants
|
880 Participants
|
|
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Not Continued Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 subscores and ranges from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=32 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
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|---|---|
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Change From Baseline in Complete Mayo Scores
|
-2.1 score on a scale
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=590 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Change From Baseline in Partial Mayo Scores
|
-3.4 score on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
The SIBDQ is an instrument used to assess quality of life (QOL) and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=653 Participants
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
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Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
|
9.3 score on a scale
Standard Deviation 12.86
|
Adverse Events
Vedolizumab 300 mg
Serious events: 82 serious events
Other events: 29 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Vedolizumab 300 mg
n=1091 participants at risk
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
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|---|---|
|
Infections and infestations
Appendicitis
|
0.27%
3/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Liver abscess
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Enteritis infectious
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
Herpes zoster oticus
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Infections and infestations
COVID-19
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.27%
3/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.18%
2/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
3/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Eye disorders
Cataract
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.18%
2/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.4%
37/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Intussusception
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.18%
2/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.18%
2/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
General disorders
Pyrexia
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Investigations
Neutrophil toxic granulation present
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Investigations
C-reactive protein increased
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.09%
1/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
Other adverse events
| Measure |
Vedolizumab 300 mg
n=1091 participants at risk
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.4%
15/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
14/1091 • Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place