Trial Outcomes & Findings for Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (NCT NCT04075825)

Last Updated: 2025-04-23

Results Overview

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

Results posted on

2025-04-23

Participant Flow

Participants took part in the study at various investigative sites globally from 05 November 2019 to 02 April 2024.

Participants diagnosed with Complex Perianal Fistula in Crohn's Disease (CD) who completed the Week 52 visit in the parent study ADMIRE-CD II (Cx601-0303, NCT03279081) were enrolled. Participants remained in the treatment group (placebo or darvadstrocel) to which they were assigned in ADMIRE-CD II study.

Participant milestones

Participant milestones
Measure	Placebo Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Overall Study STARTED	74	76
Overall Study COMPLETED	57	63
Overall Study NOT COMPLETED	17	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Overall Study Withdrawal by Subject	6	8
Overall Study Physician Decision	3	1
Overall Study Lost to Follow-up	5	1
Overall Study Participation in New Clinical Trial	1	1
Overall Study Reason Not Specified	2	2

Baseline Characteristics

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Total n=150 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 11.33 • n=5 Participants	40.6 years STANDARD_DEVIATION 12.04 • n=7 Participants	39.8 years STANDARD_DEVIATION 11.69 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	35 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	62 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	68 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	40 Participants	43 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)	14 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Anaphylactic Reaction	0 Participants	0 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Immunogenicity/Allo-immunoreactions	3 Participants	7 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Tumorgenicity	1 Participants	3 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Fistula, Abscess	6 Participants	7 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Ectopic Tissue Formation	1 Participants	0 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Hypersensitivity	3 Participants	3 Participants
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Malignancy	1 Participants	2 Participants

SECONDARY outcome

Timeframe: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Week 52	36.49 percentage of participants Interval 25.52 to 47.45	50.00 percentage of participants Interval 38.76 to 61.24
Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Week 104	31.08 percentage of participants Interval 20.54 to 41.63	43.42 percentage of participants Interval 32.28 to 54.56

SECONDARY outcome

Timeframe: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Week 52	40.54 percentage of participants Interval 29.35 to 51.73	56.58 percentage of participants Interval 45.44 to 67.72
Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Week 104	32.43 percentage of participants Interval 21.77 to 43.1	47.37 percentage of participants Interval 36.14 to 58.59

SECONDARY outcome

Timeframe: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. . Overall number analyzed is the number of participants who were in combined remission at Week 52 of ADMIRE-CD II.

Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection \>2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment. Combined remission at Week 52 was defined as clinically assessed closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment. Percentages were rounded off to the nearest second decimal place.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=40 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II	54.76 percentage of participants Interval 39.71 to 69.81	42.50 percentage of participants Interval 27.18 to 57.82

SECONDARY outcome

Timeframe: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment. Percentages were rounded off to the nearest second decimal place.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)	29.73 percentage of participants Interval 19.32 to 40.14	36.84 percentage of participants Interval 26.0 to 47.69

SECONDARY outcome

Timeframe: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Percentages were rounded off to the nearest second decimal place.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156	9.62 percentage of participants Interval 3.2 to 21.03	7.02 percentage of participants Interval 1.95 to 17.0

SECONDARY outcome

Timeframe: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. Overall number analyzed is the number of participants with data available at ADMIRE-CD II Baseline. Number analyzed is the number of participants with data available for analyses at the specified timepoint.

The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'discharge' was used for this outcome measure. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=67 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 ADMIRE-CD II Baseline Score	1.53 score on a scale Standard Deviation 1.072	1.25 score on a scale Standard Deviation 0.893
Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 Change from ADMIRE-CD II Baseline up to Week 52 of this study	-0.67 score on a scale Standard Deviation 1.178	-0.56 score on a scale Standard Deviation 1.218
Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 Change from ADMIRE-CD II Baseline up to Week 104 of this study	-0.67 score on a scale Standard Deviation 1.279	-0.50 score on a scale Standard Deviation 1.128

SECONDARY outcome

Timeframe: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'pain' was used for this outcome measure. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=67 Participants Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 ADMIRE-CD II Baseline Score	1.25 score on a scale Standard Deviation 1.060	1.06 score on a scale Standard Deviation 0.936
Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 Change from ADMIRE-CD II Baseline up to Week 52 of this study	-0.49 score on a scale Standard Deviation 1.391	-0.54 score on a scale Standard Deviation 1.010
Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 Change from ADMIRE-CD II Baseline up to Week 104 of this study	-0.56 score on a scale Standard Deviation 1.271	-0.45 score on a scale Standard Deviation 1.060

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 11 other events

Deaths: 0 deaths

Darvadstrocel

Serious events: 11 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=74 participants at risk Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 participants at risk Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Infections and infestations COVID-19	10.8% 8/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	11.8% 9/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Investigations SARS-CoV-2 test positive	4.1% 3/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	6.6% 5/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=74 participants at risk Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.	Darvadstrocel n=76 participants at risk Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
Infections and infestations Abdominal abscess	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Infections and infestations Anal abscess	2.7% 2/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	3.9% 3/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Anal fistula	2.7% 2/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Anorectal disorder	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Infections and infestations COVID-19	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	2.6% 2/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Renal and urinary disorders Calculus urinary	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Crohn's disease	2.7% 2/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Psychiatric disorders Depression	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Faecaloma	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Musculoskeletal and connective tissue disorders Fistula discharge	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Gastrointestinal obstruction	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Intestinal obstruction	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Nervous system disorders Multiple sclerosis	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Renal and urinary disorders Nephrolithiasis	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Infections and infestations Perineal abscess	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Proctalgia	2.7% 2/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Gastrointestinal disorders Terminal ileitis	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Infections and infestations Tonsillitis	0.00% 0/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	1.3% 1/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Infections and infestations Urinary tract infection	1.4% 1/74 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.	0.00% 0/76 • Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II) Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.