Search review questions

Clinical relapse (at 30‐32 weeks, CDAI > 150) · patients with Crohn's disease (mixed disease activity population with clinical response at baseline)

Loss of clinical response · Crohn's disease patients (in remission at baseline)

Withdrawal due to adverse events · Crohn's disease patients (in remission at baseline)

Serious adverse events (at 2 years) · Crohn's disease patients (in remission at baseline)

Clinical relapse (at 52 weeks, HBI > 4) · patients with Crohn's disease (with mixed/low disease activity at baseline)

Loss of clinical response (at 52 weeks, HBI change from baseline of less than 4 points and a total score of less than 7 points) · patients with Crohn's disease (with mixed/low disease activity at baseline)

Withdrawal due to adverse events (at 52 weeks) · patients with Crohn's disease (with mixed/low disease activity at baseline)

Serious adverse events (at 52 weeks) · patients with Crohn's disease (with mixed/low disease activity at baseline)

Clinical relapse (at 22 weeks, CDAI > 150) · patients with Crohn's disease (active disease population with clinical response at baseline)

Loss of clinical response (at 22 weeks, less than 100 points in CDAI change) · patients with Crohn's disease (active disease population with clinical response at baseline)

Withdrawal due to adverse events (at 30 weeks) · patients with Crohn's disease (active disease population with clinical response at baseline)

Loss of clinical response (at 32 weeks, less than 70 points in CDAI change) · patients with Crohn's disease (mixed disease activity population with clinical response at baseline)

Serious adverse events · patients with Crohn's disease (active disease population with clinical response at baseline)

Clinical relapse · patients with Crohn's disease (active disease population with clinical response at baseline)

Loss of clinical response (at 56 weeks, less than 100 points in CDAI change) · patients with Crohn's disease (active disease population with clinical response at baseline)

Withdrawal due to adverse events (at 56 weeks) · patients with Crohn's disease (active disease population with clinical response at baseline)

Serious adverse events (at 56 weeks) · patients with Crohn's disease (active disease population with clinical response at baseline)

Withdrawal due to adverse events (at 32‐54 weeks) · patients with Crohn's disease (mixed disease activity population with clinical response at baseline)

Serious adverse events (at 54 weeks) · patients with Crohn's disease (mixed disease activity population with clinical response at baseline)

Clinical relapse (at 48 weeks, CDAI of 150 or greater together with an increase in CDAImore than 70 points above baseline over 2 consecutive weeks or definitive clinical relapse requiring immediate intervention, as judged by the treating physician) · Crohn's disease patients (in remission at baseline)

Loss of clinical response · Crohn's disease patients (in remission at baseline)

Withdrawal due to adverse events (at 48 weeks) · Crohn's disease patients (in remission at baseline)

Serious adverse events (at 48 weeks to 2 years) · Crohn's disease patients (in remission at baseline)

Clinical relapse · Crohn's disease patients (in remission at baseline)

Clinical remission (14 days) · people with mild‐to‐moderate disease (Rachmilewitz index) or active disease (SCCAI score of 4 to 10)

Withdrawals due to adverse events (9 weeks) · people with mild to moderately active ulcerative colitis

Clinical remission · people with mild‐to‐moderate ulcerative colitis based on Truelove and Witts criteria

Clinical improvement (Lichtiger index) (4 weeks) · people with mild‐to‐moderate ulcerative colitis based on Truelove and Witts criteria

Quality of life · people with mild‐to‐moderate ulcerative colitis based on Truelove and Witts criteria

Total adverse events · people with mild‐to‐moderate ulcerative colitis based on Truelove and Witts criteria

Withdrawals due to adverse events · people with mild‐to‐moderate ulcerative colitis based on Truelove and Witts criteria

Clinical relapse (6 months) · people with histologically confirmed diagnosis of ulcerative colitis in remission

Clinical improvement (partial Mayo score) (60 days) · people with histologically confirmed diagnosis of ulcerative colitis in remission

Quality of life (IBDQ) (60 days) · people with histologically confirmed diagnosis of ulcerative colitis in remission

Total adverse events (6 months) · people with histologically confirmed diagnosis of ulcerative colitis in remission

Clinical improvement (Rachmilewitz index) (14 days) · people with mild‐to‐moderate disease (Rachmilewitz index) or active disease (SCCAI score of 4 to 10)

Withdrawals due to adverse events (60 days to 6 months) · people with histologically confirmed diagnosis of ulcerative colitis in remission

Clinical relapse (4 weeks) · people in remission or with mildly activeulcerative colitis

Clinical improvement · people in remission or with mildly activeulcerative colitis

Quality of life (IBDQ) (4 weeks) · people in remission or with mildly activeulcerative colitis

Total adverse events · people in remission or with mildly activeulcerative colitis

Withdrawals due to adverse events (4 weeks) · people in remission or with mildly activeulcerative colitis

Clinical relapse (4 weeks) · people in remission or with mildly activeulcerative colitis

Clinical improvement · people in remission or with mildly activeulcerative colitis

Quality of life (IBDQ) (4 weeks) · people in remission or with mildly activeulcerative colitis

Total adverse events · people in remission or with mildly activeulcerative colitis

Quality of life (IBDQ) (2 or 3 months) · people with mild‐to‐moderate disease (Rachmilewitz index) or active disease (SCCAI score of 4 to 10)

Withdrawals due to adverse events (4 weeks) · people in remission or with mildly activeulcerative colitis

Total adverse events · people with mild‐to‐moderate disease (Rachmilewitz index) or active disease (SCCAI score of 4 to 10)

Withdrawals due to adverse events (14 days to 2 or 3 months) · people with mild‐to‐moderate disease (Rachmilewitz index) or active disease (SCCAI score of 4 to 10)