Trial Outcomes & Findings for A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy (NCT NCT03345836)
NCT ID: NCT03345836
Last Updated: 2022-08-15
Results Overview
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI \<150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).
COMPLETED
PHASE3
624 participants
Week 12
2022-08-15
Participant Flow
This study had 3 Parts: Part 1:randomized,double-blind,placebo-controlled InductionPeriod(IP); Part 2:Once enrollment for Part1 completed,participants were further enrolled in open-label,single-arm active IP to receive upadacitinib 45mg.Clinical non-responders from Parts1 and 2 entered Part3; Part 3:ExtendedTreatmentPeriod for non-responders from Part1 or 2 had 3 cohorts:Cohort 1=placebo participants from Part 1,Cohort2=upadacitinib participants from Part 1.Cohort3=participants from Part2.
Participant milestones
| Measure |
Part 1 (Double-blind): Placebo
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
|
Part 1 (Double-blind): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Period 1: DB and OL Induction (12 Weeks)
STARTED
|
171
|
324
|
129
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
COMPLETED
|
149
|
291
|
123
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
NOT COMPLETED
|
22
|
33
|
6
|
0
|
0
|
0
|
|
Period 2: 12-Week Extended Treatment
STARTED
|
0
|
0
|
0
|
78
|
69
|
14
|
|
Period 2: 12-Week Extended Treatment
COMPLETED
|
0
|
0
|
0
|
67
|
51
|
8
|
|
Period 2: 12-Week Extended Treatment
NOT COMPLETED
|
0
|
0
|
0
|
11
|
18
|
6
|
Reasons for withdrawal
| Measure |
Part 1 (Double-blind): Placebo
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
|
Part 1 (Double-blind): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Period 1: DB and OL Induction (12 Weeks)
Adverse Event
|
5
|
17
|
2
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
Withdrew Consent
|
8
|
8
|
3
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
Lack of Efficacy
|
8
|
4
|
0
|
0
|
0
|
0
|
|
Period 1: DB and OL Induction (12 Weeks)
Reason not Specified
|
1
|
3
|
1
|
0
|
0
|
0
|
|
Period 2: 12-Week Extended Treatment
Adverse Event
|
0
|
0
|
0
|
8
|
5
|
0
|
|
Period 2: 12-Week Extended Treatment
Withdrew Consent
|
0
|
0
|
0
|
0
|
5
|
1
|
|
Period 2: 12-Week Extended Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2: 12-Week Extended Treatment
Lack of Efficacy
|
0
|
0
|
0
|
2
|
6
|
3
|
|
Period 2: 12-Week Extended Treatment
Coronavirus Disease (COVID-19) Logistical Restrictions
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2: 12-Week Extended Treatment
Reason not Specified
|
0
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
Baseline characteristics by cohort
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the Double-blind Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Double-blind Induction Period.
|
Part 2 (Open Label): Upadacitinib 45 mg
n=129 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label Induction Period.
|
Total
n=624 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Part 1 (Double Blind)
|
37.5 years
n=171 Participants • Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
|
38.4 years
n=324 Participants • Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
|
—
|
38.1 years
n=495 Participants • Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
|
|
Age, Continuous
Part 2 (Open Label)
|
—
|
—
|
39.1 years
n=129 Participants • Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
|
39.1 years
n=129 Participants • Results are reported separately for Part 1 (Double Blind) and Part 2 (Open Label.)
|
|
Sex: Female, Male
Female
|
75 Participants
n=171 Participants
|
155 Participants
n=324 Participants
|
60 Participants
n=129 Participants
|
290 Participants
n=624 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=171 Participants
|
169 Participants
n=324 Participants
|
69 Participants
n=129 Participants
|
334 Participants
n=624 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=171 Participants
|
24 Participants
n=324 Participants
|
8 Participants
n=129 Participants
|
40 Participants
n=624 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=171 Participants
|
300 Participants
n=324 Participants
|
121 Participants
n=129 Participants
|
584 Participants
n=624 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=624 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=171 Participants
|
1 Participants
n=324 Participants
|
0 Participants
n=129 Participants
|
2 Participants
n=624 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=171 Participants
|
69 Participants
n=324 Participants
|
11 Participants
n=129 Participants
|
118 Participants
n=624 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=171 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=624 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=171 Participants
|
19 Participants
n=324 Participants
|
5 Participants
n=129 Participants
|
30 Participants
n=624 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=171 Participants
|
230 Participants
n=324 Participants
|
113 Participants
n=129 Participants
|
469 Participants
n=624 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=171 Participants
|
5 Participants
n=324 Participants
|
0 Participants
n=129 Participants
|
5 Participants
n=624 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=624 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI \<150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
|
21.1 percentage of participants
Interval 14.9 to 27.2
|
38.9 percentage of participants
Interval 33.6 to 44.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Response at Week 12
|
3.5 percentage of participants
Interval 0.8 to 6.3
|
34.6 percentage of participants
Interval 29.4 to 39.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)Population: Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE 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 |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
n=129 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
n=78 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
n=69 Participants
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
n=14 Participants
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
112 Participants
|
221 Participants
|
86 Participants
|
53 Participants
|
45 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤2.8 and average daily abdominal pain (AP) score ≤1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
|
14.0 percentage of participants
Interval 8.8 to 19.2
|
39.8 percentage of participants
Interval 34.5 to 45.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
Endoscopic remission was defined per SES-CD. SES-CD ≤4 and at least 2-point reduction from Baseline and no subscore \>1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 12
|
2.3 percentage of participants
Interval 0.1 to 4.6
|
19.1 percentage of participants
Interval 14.9 to 23.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1. Overall Number of Participants Analyzed are the number of participants taking corticosteroids at Baseline.
As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI \<150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=60 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=108 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline
|
11.7 percentage of participants
Interval 3.5 to 19.8
|
34.3 percentage of participants
Interval 25.3 to 43.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1. Overall Number of Participants Analyzed are the number of participants with data available at the given timepoint.
The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=129 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=278 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12
|
3.9 score on a scale
Standard Error 0.97
|
11.4 score on a scale
Standard Error 0.69
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1. Overall Number of Participants Analyzed are the number of participants with data available at the given timepoint.
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 1=worst to 7= best. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=130 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=280 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
|
21.6 score on a scale
Standard Error 3.02
|
46.0 score on a scale
Standard Error 2.14
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
|
12.4 percentage of participants
Interval 7.4 to 17.4
|
33.2 percentage of participants
Interval 28.0 to 38.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
|
27.5 percentage of participants
Interval 20.8 to 34.2
|
50.5 percentage of participants
Interval 45.1 to 56.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI \<150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4
|
17.7 percentage of participants
Interval 11.9 to 23.4
|
29.6 percentage of participants
Interval 24.7 to 34.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12 in Part 1: Double-blind Induction PeriodPopulation: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=171 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)
|
8.8 percentage of participants
Interval 4.5 to 13.0
|
6.2 percentage of participants
Interval 3.6 to 8.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT1 Population included all randomized participants who received at least one dose of DB study drug during Part 1. Overall Number of Participants Analyzed are the number of participants with any EIMs at Baseline.
EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver. Results were based on NRI-C.
Outcome measures
| Measure |
Part 1 (Double Blind): Placebo
n=60 Participants
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=131 Participants
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in Participants With EIMs at Baseline
|
21.7 percentage of participants
Interval 11.2 to 32.1
|
32.8 percentage of participants
Interval 24.8 to 40.9
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 (Double-blind): Placebo
Part 1 (Double Blind): Upadacitinib 45 mg
Part 2 (Open Label): Upadacitinib 45 mg
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Serious adverse events
| Measure |
Part 1 (Double-blind): Placebo
n=171 participants at risk
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open Label): Upadacitinib 45 mg
n=129 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the OL Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
n=78 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
n=69 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
n=14 participants at risk
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
COLITIS
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
5.8%
10/171 • Number of events 13 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.2%
7/324 • Number of events 7 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.1%
4/129 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.8%
3/78 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
5.8%
4/69 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.93%
3/324 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
General disorders
PYREXIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
ANAL ABSCESS
|
1.2%
2/171 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.93%
3/324 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
COVID-19
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.6%
2/129 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
COLONIC ABSCESS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
RETROPERITONEAL ABSCESS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Musculoskeletal and connective tissue disorders
ANKYLOSING SPONDYLITIS
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Psychiatric disorders
DEPRESSION
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Psychiatric disorders
DRUG USE DISORDER
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
Other adverse events
| Measure |
Part 1 (Double-blind): Placebo
n=171 participants at risk
Participants received upadacitinib matching placebo tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 1 (Double Blind): Upadacitinib 45 mg
n=324 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
|
Part 2 (Open Label): Upadacitinib 45 mg
n=129 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the OL Induction Period.
|
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
n=78 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
n=69 participants at risk
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
|
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
n=14 participants at risk
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.3%
9/171 • Number of events 12 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.9%
16/324 • Number of events 17 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.7%
6/129 • Number of events 6 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.8%
3/78 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.4%
11/171 • Number of events 13 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.8%
9/324 • Number of events 10 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.8%
3/78 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.2%
7/324 • Number of events 7 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
5.4%
7/129 • Number of events 7 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
7.6%
13/171 • Number of events 13 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.7%
12/324 • Number of events 12 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.9%
5/129 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
6.4%
5/78 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
5.8%
4/69 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
NAUSEA
|
4.7%
8/171 • Number of events 9 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.6%
15/324 • Number of events 15 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.3%
3/129 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.8%
3/78 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
4/171 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.5%
8/324 • Number of events 8 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
General disorders
PYREXIA
|
4.7%
8/171 • Number of events 8 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.0%
13/324 • Number of events 13 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.1%
4/129 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
5.1%
4/78 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
FOLLICULITIS
|
0.58%
1/171 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.5%
5/324 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.6%
2/129 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
6.4%
5/78 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
INFLUENZA
|
1.2%
2/171 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.8%
9/324 • Number of events 10 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.6%
2/78 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.3%
3/69 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.9%
5/171 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
23/324 • Number of events 24 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.6%
2/129 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
3.8%
3/78 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.9%
2/69 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.9%
5/171 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
5.2%
17/324 • Number of events 18 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.6%
2/78 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.9%
2/69 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.31%
1/324 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.4%
11/171 • Number of events 11 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.2%
7/324 • Number of events 7 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.6%
2/129 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.6%
2/78 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.4%
11/171 • Number of events 12 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.2%
4/324 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.6%
2/78 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.4%
1/69 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Musculoskeletal and connective tissue disorders
FISTULA DISCHARGE
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Nervous system disorders
HEADACHE
|
5.3%
9/171 • Number of events 10 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
6.2%
20/324 • Number of events 24 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
6.2%
8/129 • Number of events 8 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
2.6%
2/78 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Psychiatric disorders
INSOMNIA
|
1.2%
2/171 • Number of events 2 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.5%
5/324 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.78%
1/129 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
1.3%
1/78 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/324 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.3%
4/171 • Number of events 4 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
4.6%
15/324 • Number of events 16 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
14.0%
18/129 • Number of events 18 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
6.4%
5/78 • Number of events 5 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/14 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/171 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.93%
3/324 • Number of events 3 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/129 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/78 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
0.00%
0/69 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Safety Population for Part 1 (SA1)=all participants who received at least one dose of the study drug in Part 1,SA2=all participants who received at least one dose of the study drug in Part 2, and SA3=all participants who received at least one dose of the study drug (upadacitinib 30 mg or upadacitinib 45 mg) in Part 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER