Trial Outcomes & Findings for GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease (NCT NCT03139604)
NCT ID: NCT03139604
Last Updated: 2025-09-02
Results Overview
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
439 participants
Primary outcome timeframe
Day 28
Results posted on
2025-09-02
Participant Flow
Participants took part in the study at 128 investigative sites in 19 different countries.
A total of 498 participants were screened for this study, of which 59 participants were screen failures and 439 participants were randomized to treatment.
Participant milestones
| Measure |
Itacitinib Plus Corticosteroids
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
220
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
219
|
220
|
Reasons for withdrawal
| Measure |
Itacitinib Plus Corticosteroids
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Overall Study
Other
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
16
|
17
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Death
|
65
|
67
|
|
Overall Study
Study Terminated by Sponsor
|
122
|
127
|
|
Overall Study
Final EOS data missing due to COVID-19 restrictions that affected on-site monitoring
|
5
|
3
|
Baseline Characteristics
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Baseline characteristics by cohort
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Total
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 12.96 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
167 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
196 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) Population
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
|
74.0 Percentage of Participants
Interval 67.6 to 79.7
|
66.4 Percentage of Participants
Interval 59.7 to 72.6
|
SECONDARY outcome
Timeframe: Month 6,9,12 and 24Population: Full Analysis Set (FAS) Population
Defined as the percentage of participants who died due to causes other than malignancy relapse.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Nonrelapse Mortality
6 Months
|
36 participants
|
37 participants
|
|
Nonrelapse Mortality
9 Months
|
46 participants
|
45 participants
|
|
Nonrelapse Mortality
12 Months
|
51 participants
|
52 participants
|
|
Nonrelapse Mortality
24 Months
|
56 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 monthsPopulation: Full Analysis Set (FAS) Population
Defined as the interval from first response until GVHD progression or death.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Duration of Response
|
587 days
Interval 513.0 to
Upper bound is not estimable
|
NA days
Not Estimable
|
SECONDARY outcome
Timeframe: Protocol-defined timepoints up to Day 28Population: All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.
Defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=162 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Cmax of Itacitinib When Administered in Combination With Corticosteroids
|
796 nM
Standard Deviation 642
|
—
|
SECONDARY outcome
Timeframe: Protocol-defined timepoints up to Day 28Population: All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7 as this is more representative of true steady state. Day 28 is positively biased as non responders are withdrawn from study by D28.
Defined as minimum observed plasma concentration.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=62 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Cmin of Itacitinib When Administered in Combination With Corticosteroids
|
72.5 nM
Standard Deviation 121
|
—
|
SECONDARY outcome
Timeframe: Protocol-defined timepoints up to Day 28Population: All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.
Defined as time to maximum plasma concentration.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=62 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Tmax of Itacitinib When Administered in Combination With Corticosteroids
|
2.1 hrs
Interval 0.83 to 5.3
|
—
|
SECONDARY outcome
Timeframe: Protocol-defined timepoints up to Day 28Population: All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.
Defined as area under the concentration-time curve.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=62 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
AUC of Itacitinib When Administered in Combination With Corticosteroids
|
6720 nM*h
Standard Deviation 6210
|
—
|
SECONDARY outcome
Timeframe: Protocol-defined timepoints up to Day 28Population: All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.
Defined as oral dose clearance.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=62 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
CL/F of Itacitinib When Administered in Combination With Corticosteroids
|
104 L/h
Standard Deviation 76.7
|
—
|
SECONDARY outcome
Timeframe: End of Study, total particpation expected to average 24 monthsPopulation: Full Analysis Set (FAS) Population who were responders
Defined as the interval from treatment initiation to first response
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=195 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=185 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Time to Response
|
9.9 days
Standard Deviation 6.25
|
10.1 days
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Randomization through end of Study, study duration expected to average 24 monthsPopulation: Full Analysis Set (FAS) Population
Defined as the proportion of subjects whose underlying hematologic disease relapses
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=217 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Relapse Rate of Malignant and Nonmalignant Hematologic Disease
|
12.4 percentage
|
11.4 percentage
|
SECONDARY outcome
Timeframe: Randomization through end of Study, study duration expected to average 24 monthsPopulation: Full Analysis Set (FAS) Population
Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Malignancy Relapse-related Mortality Rate
|
6.4 percentage
|
7.7 percentage
|
SECONDARY outcome
Timeframe: 6 months from randomizationPopulation: Full Analysis Set (FAS) Population
Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Failure-free Survival
|
44.29 proportion of participants
|
40.00 proportion of participants
|
SECONDARY outcome
Timeframe: End of Study up to approximately 24 monthsPopulation: Full Analysis Set (FAS) Population
Defined as the interval from study enrollment to death due to any cause.
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Overall Survival (OS)
|
365 days
Interval 1.0 to 867.0
|
348.5 days
Interval 1.0 to 827.0
|
SECONDARY outcome
Timeframe: 30-35 days after end of treatment, approximately 24 monthsPopulation: Safety Analysis Set
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=215 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=216 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Number of Treatment-emergent Adverse Events With INCB39110
|
208 participants
|
214 participants
|
SECONDARY outcome
Timeframe: Randomization through end of Study, study duration expected to average 24 monthsPopulation: Full Analysis Set (FAS) Population
Defined as \> 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (\< 0.5 × 109/L) and/or thrombocytopenia (\< 20 × 109/L) within 2 months of transplantion
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Incidence Rate of Secondary Graft Failure
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28, 56, 100, and 180Population: Safety Analysis Set
Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=215 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=216 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Proportion of Subjects Who Discontinue Corticosteroids
Day 28
|
3 participants
|
3 participants
|
|
Proportion of Subjects Who Discontinue Corticosteroids
Day 56
|
16 participants
|
11 participants
|
|
Proportion of Subjects Who Discontinue Corticosteroids
Day 100
|
39 participants
|
45 participants
|
|
Proportion of Subjects Who Discontinue Corticosteroids
Day 180
|
39 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Days 56 and 100Population: Full Analysis Set (FAS) Population
Summary statistics of subjects discontinuing immunosuppressive medications will be calculated
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Proportion of Subjects Who Discontinue Immunosuppressive Medications
Day 56
|
12 participants
|
10 participants
|
|
Proportion of Subjects Who Discontinue Immunosuppressive Medications
Day 100
|
11 participants
|
8 participants
|
SECONDARY outcome
Timeframe: up to day 100Population: Full Analysis Set (FAS) Population
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Incidence Rate of aGVHD Flares
|
42 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Days 180 and 365Population: Full Analysis Set (FAS) Population
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Incidence Rate of cGVHD
Day 180
|
25 participants
|
36 participants
|
|
Incidence Rate of cGVHD
Day 365
|
43 participants
|
58 participants
|
SECONDARY outcome
Timeframe: Days 14, 56 and 100Population: Full Analysis Set (FAS) Population
Outcome measures
| Measure |
Itacitinib Plus Corticosteroids
n=219 Participants
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=220 Participants
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
|---|---|---|
|
Objective Response Rate
Day 14
|
170 participants
|
160 participants
|
|
Objective Response Rate
Day 56
|
138 participants
|
124 participants
|
|
Objective Response Rate
Day 100
|
92 participants
|
96 participants
|
Adverse Events
Itacitinib Plus Corticosteroids
Serious events: 133 serious events
Other events: 207 other events
Deaths: 69 deaths
Placebo Plus Corticosteroids
Serious events: 131 serious events
Other events: 206 other events
Deaths: 69 deaths
Total
Serious events: 264 serious events
Other events: 413 other events
Deaths: 138 deaths
Serious adverse events
| Measure |
Itacitinib Plus Corticosteroids
n=215 participants at risk
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=216 participants at risk
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Total
n=431 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Transaminases increased
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Vascular device infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Peritonitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Rotavirus test positive
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Shock
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Sinusitis aspergillus
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Spinal subdural haematoma
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Status epilepticus
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
4/215 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
2.3%
5/216 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
2.1%
9/431 • Number of events 9 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Hypotension
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Influenza
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Lethargy
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Limbic encephalitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Liver function test increased
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Microangiopathy
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Mucormycosis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
2.3%
5/216 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
1.6%
7/431 • Number of events 7 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Abscess
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Acute graft versus host disease
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.4%
6/431 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Neutrophil count decreased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Oedema
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Oedema peripheral
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Oral herpes
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.9%
4/215 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Eye disorders
Photophobia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia
|
5.1%
11/215 • Number of events 12 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
5.6%
24/431 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia influenzal
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia necrotising
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.47%
1/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Presyncope
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pseudomonal sepsis
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pseudomonas infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Pyrexia
|
7.0%
15/215 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
4.6%
10/216 • Number of events 10 • 30 days after last dose approximately up to 24 months
|
5.8%
25/431 • Number of events 29 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.47%
1/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Renal impairment
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
2.3%
5/216 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
1.9%
8/431 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Sepsis
|
2.3%
5/215 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
2.6%
11/431 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Septic shock
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
1.9%
8/431 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Sinusitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.9%
4/216 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Syncope
|
1.9%
4/215 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
2.1%
9/431 • Number of events 9 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.4%
6/431 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Toxic encephalopathy
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/215 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.9%
4/216 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
1.6%
7/431 • Number of events 7 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Weight decreased
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
White blood cell count decreased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Adenoviral hepatitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Congenital, familial and genetic disorders
Bartter's syndrome
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell crisis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood bilirubin increased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Bullous oedema of the bladder
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Clostridium test positive
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Diabetic coma
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Disseminated aspergillosis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Embolism
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Enterococcus test positive
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Klebsiella sepsis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Klebsiella test positive
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Cardiac disorders
Myocardial infarction
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
8/215 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
2.3%
5/216 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
3.0%
13/431 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Adenovirus infection
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Aspergillus infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Asthenia
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
BK virus infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
1.9%
4/216 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood fibrinogen decreased
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Bronchitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Psychiatric disorders
Confusional state
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cystitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
1.9%
4/215 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus infection
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
1.2%
5/431 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
2.8%
6/215 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
1.6%
7/431 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
2.3%
5/215 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
2.3%
5/216 • Number of events 5 • 30 days after last dose approximately up to 24 months
|
2.3%
10/431 • Number of events 10 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.70%
3/431 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
10/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
5.3%
23/431 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Encephalitis
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Escherichia infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Escherichia sepsis
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Fatigue
|
0.93%
2/215 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
7/215 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
3.7%
8/216 • Number of events 10 • 30 days after last dose approximately up to 24 months
|
3.5%
15/431 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Fungal infection
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
General disorders
General physical health deterioration
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Graft versus host disease
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
0.93%
4/431 • Number of events 4 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
1.4%
3/215 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
2.1%
9/431 • Number of events 9 • 30 days after last dose approximately up to 24 months
|
|
Immune system disorders
Graft versus host disease in lung
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/215 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.00%
0/216 • 30 days after last dose approximately up to 24 months
|
0.23%
1/431 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Herpes zoster
|
0.47%
1/215 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
1/216 • Number of events 1 • 30 days after last dose approximately up to 24 months
|
0.46%
2/431 • Number of events 2 • 30 days after last dose approximately up to 24 months
|
Other adverse events
| Measure |
Itacitinib Plus Corticosteroids
n=215 participants at risk
Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Placebo Plus Corticosteroids
n=216 participants at risk
Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.
|
Total
n=431 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
26/215 • Number of events 32 • 30 days after last dose approximately up to 24 months
|
12.0%
26/216 • Number of events 28 • 30 days after last dose approximately up to 24 months
|
12.1%
52/431 • Number of events 60 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
11/215 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
7.4%
32/431 • Number of events 36 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
30/215 • Number of events 39 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
11.8%
51/431 • Number of events 62 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
29.3%
63/215 • Number of events 80 • 30 days after last dose approximately up to 24 months
|
25.0%
54/216 • Number of events 66 • 30 days after last dose approximately up to 24 months
|
27.1%
117/431 • Number of events 146 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
23/215 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
8.3%
18/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
9.5%
41/431 • Number of events 43 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
10.7%
23/215 • Number of events 37 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
8.4%
36/431 • Number of events 55 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Asthenia
|
5.6%
12/215 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
8.8%
19/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
7.2%
31/431 • Number of events 34 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
17/215 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 25 • 30 days after last dose approximately up to 24 months
|
8.8%
38/431 • Number of events 45 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
12/215 • Number of events 14 • 30 days after last dose approximately up to 24 months
|
7.4%
16/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
6.5%
28/431 • Number of events 33 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood cholesterol increased
|
7.4%
16/215 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
6.3%
27/431 • Number of events 32 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Blood creatinine increased
|
11.6%
25/215 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
8.8%
19/216 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
10.2%
44/431 • Number of events 47 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
11.6%
25/215 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 22 • 30 days after last dose approximately up to 24 months
|
10.7%
46/431 • Number of events 49 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
32/215 • Number of events 35 • 30 days after last dose approximately up to 24 months
|
19.4%
42/216 • Number of events 54 • 30 days after last dose approximately up to 24 months
|
17.2%
74/431 • Number of events 89 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus infection
|
7.4%
16/215 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
4.6%
10/216 • Number of events 12 • 30 days after last dose approximately up to 24 months
|
6.0%
26/431 • Number of events 32 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
12.1%
26/215 • Number of events 35 • 30 days after last dose approximately up to 24 months
|
11.1%
24/216 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
11.6%
50/431 • Number of events 61 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
15.8%
34/215 • Number of events 38 • 30 days after last dose approximately up to 24 months
|
12.0%
26/216 • Number of events 30 • 30 days after last dose approximately up to 24 months
|
13.9%
60/431 • Number of events 68 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.2%
24/215 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
10.6%
23/216 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
10.9%
47/431 • Number of events 52 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
19.5%
42/215 • Number of events 48 • 30 days after last dose approximately up to 24 months
|
19.9%
43/216 • Number of events 60 • 30 days after last dose approximately up to 24 months
|
19.7%
85/431 • Number of events 108 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Dizziness
|
10.7%
23/215 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
7.9%
17/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
9.3%
40/431 • Number of events 43 • 30 days after last dose approximately up to 24 months
|
|
Eye disorders
Dry eye
|
8.4%
18/215 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
7.9%
17/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
8.1%
35/431 • Number of events 37 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
14/215 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
8.3%
18/216 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
7.4%
32/431 • Number of events 39 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.0%
28/215 • Number of events 31 • 30 days after last dose approximately up to 24 months
|
6.9%
15/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
10.0%
43/431 • Number of events 50 • 30 days after last dose approximately up to 24 months
|
|
Renal and urinary disorders
Dysuria
|
7.9%
17/215 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
3.7%
8/216 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
5.8%
25/431 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
9.3%
20/215 • Number of events 22 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
9.5%
41/431 • Number of events 45 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Fatigue
|
13.0%
28/215 • Number of events 32 • 30 days after last dose approximately up to 24 months
|
17.1%
37/216 • Number of events 54 • 30 days after last dose approximately up to 24 months
|
15.1%
65/431 • Number of events 86 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.1%
11/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
3.2%
7/216 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
4.2%
18/431 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Headache
|
9.3%
20/215 • Number of events 21 • 30 days after last dose approximately up to 24 months
|
14.8%
32/216 • Number of events 39 • 30 days after last dose approximately up to 24 months
|
12.1%
52/431 • Number of events 60 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
21.9%
47/215 • Number of events 56 • 30 days after last dose approximately up to 24 months
|
23.1%
50/216 • Number of events 57 • 30 days after last dose approximately up to 24 months
|
22.5%
97/431 • Number of events 113 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
9/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
7.4%
16/216 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
5.8%
25/431 • Number of events 34 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Hypertension
|
21.4%
46/215 • Number of events 52 • 30 days after last dose approximately up to 24 months
|
14.4%
31/216 • Number of events 35 • 30 days after last dose approximately up to 24 months
|
17.9%
77/431 • Number of events 87 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.4%
31/215 • Number of events 33 • 30 days after last dose approximately up to 24 months
|
12.5%
27/216 • Number of events 34 • 30 days after last dose approximately up to 24 months
|
13.5%
58/431 • Number of events 67 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
12/215 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
10.6%
23/216 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
8.1%
35/431 • Number of events 39 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
16/215 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
9.3%
20/216 • Number of events 21 • 30 days after last dose approximately up to 24 months
|
8.4%
36/431 • Number of events 38 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.6%
40/215 • Number of events 51 • 30 days after last dose approximately up to 24 months
|
16.2%
35/216 • Number of events 43 • 30 days after last dose approximately up to 24 months
|
17.4%
75/431 • Number of events 94 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.6%
27/215 • Number of events 46 • 30 days after last dose approximately up to 24 months
|
9.7%
21/216 • Number of events 28 • 30 days after last dose approximately up to 24 months
|
11.1%
48/431 • Number of events 74 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
16/215 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
10.2%
22/216 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
8.8%
38/431 • Number of events 54 • 30 days after last dose approximately up to 24 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
14/215 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
5.8%
25/431 • Number of events 31 • 30 days after last dose approximately up to 24 months
|
|
Psychiatric disorders
Insomnia
|
10.2%
22/215 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
11.6%
25/216 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
10.9%
47/431 • Number of events 49 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.7%
23/215 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
8.8%
19/216 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
9.7%
42/431 • Number of events 44 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
17.7%
38/215 • Number of events 47 • 30 days after last dose approximately up to 24 months
|
15.3%
33/216 • Number of events 45 • 30 days after last dose approximately up to 24 months
|
16.5%
71/431 • Number of events 92 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
36/215 • Number of events 57 • 30 days after last dose approximately up to 24 months
|
18.5%
40/216 • Number of events 59 • 30 days after last dose approximately up to 24 months
|
17.6%
76/431 • Number of events 116 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Oedema
|
3.3%
7/215 • Number of events 7 • 30 days after last dose approximately up to 24 months
|
7.4%
16/216 • Number of events 16 • 30 days after last dose approximately up to 24 months
|
5.3%
23/431 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Oedema peripheral
|
24.7%
53/215 • Number of events 55 • 30 days after last dose approximately up to 24 months
|
24.5%
53/216 • Number of events 61 • 30 days after last dose approximately up to 24 months
|
24.6%
106/431 • Number of events 116 • 30 days after last dose approximately up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
14/215 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
6.3%
27/431 • Number of events 28 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Platelet count decreased
|
17.7%
38/215 • Number of events 45 • 30 days after last dose approximately up to 24 months
|
10.2%
22/216 • Number of events 25 • 30 days after last dose approximately up to 24 months
|
13.9%
60/431 • Number of events 70 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
13/215 • Number of events 14 • 30 days after last dose approximately up to 24 months
|
7.9%
17/216 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
7.0%
30/431 • Number of events 38 • 30 days after last dose approximately up to 24 months
|
|
General disorders
Pyrexia
|
15.8%
34/215 • Number of events 44 • 30 days after last dose approximately up to 24 months
|
14.4%
31/216 • Number of events 38 • 30 days after last dose approximately up to 24 months
|
15.1%
65/431 • Number of events 82 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.8%
6/215 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
6.5%
14/216 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
4.6%
20/431 • Number of events 21 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.0%
73/215 • Number of events 87 • 30 days after last dose approximately up to 24 months
|
31.9%
69/216 • Number of events 77 • 30 days after last dose approximately up to 24 months
|
32.9%
142/431 • Number of events 164 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Tremor
|
12.6%
27/215 • Number of events 28 • 30 days after last dose approximately up to 24 months
|
8.8%
19/216 • Number of events 21 • 30 days after last dose approximately up to 24 months
|
10.7%
46/431 • Number of events 49 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
17/215 • Number of events 25 • 30 days after last dose approximately up to 24 months
|
7.9%
17/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
7.9%
34/431 • Number of events 44 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
7.0%
15/215 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
7.9%
17/216 • Number of events 19 • 30 days after last dose approximately up to 24 months
|
7.4%
32/431 • Number of events 34 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
23/215 • Number of events 26 • 30 days after last dose approximately up to 24 months
|
11.6%
25/216 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
11.1%
48/431 • Number of events 53 • 30 days after last dose approximately up to 24 months
|
|
Psychiatric disorders
Anxiety
|
7.9%
17/215 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
7.0%
30/431 • Number of events 30 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
6/215 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
5.6%
12/216 • Number of events 16 • 30 days after last dose approximately up to 24 months
|
4.2%
18/431 • Number of events 22 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Dysgeusia
|
5.1%
11/215 • Number of events 12 • 30 days after last dose approximately up to 24 months
|
0.93%
2/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
3.0%
13/431 • Number of events 15 • 30 days after last dose approximately up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
10/215 • Number of events 10 • 30 days after last dose approximately up to 24 months
|
6.0%
13/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
5.3%
23/431 • Number of events 23 • 30 days after last dose approximately up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
9/215 • Number of events 9 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
4.6%
20/431 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
5.1%
11/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
3.9%
17/431 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
|
Vascular disorders
Hypotension
|
7.4%
16/215 • Number of events 16 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
6.3%
27/431 • Number of events 27 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
6/215 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 14 • 30 days after last dose approximately up to 24 months
|
3.9%
17/431 • Number of events 22 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
7/215 • Number of events 8 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 12 • 30 days after last dose approximately up to 24 months
|
4.2%
18/431 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
2.8%
6/215 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
3.9%
17/431 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Neutrophil count decreased
|
7.0%
15/215 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
4.2%
9/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
5.6%
24/431 • Number of events 29 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Oral candidiasis
|
5.1%
11/215 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
5.1%
22/431 • Number of events 24 • 30 days after last dose approximately up to 24 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.1%
11/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
2.8%
6/216 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
3.9%
17/431 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
|
Infections and infestations
Pneumonia
|
2.3%
5/215 • Number of events 6 • 30 days after last dose approximately up to 24 months
|
5.1%
11/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
3.7%
16/431 • Number of events 17 • 30 days after last dose approximately up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
11/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
1.4%
3/216 • Number of events 3 • 30 days after last dose approximately up to 24 months
|
3.2%
14/431 • Number of events 14 • 30 days after last dose approximately up to 24 months
|
|
Eye disorders
Vision blurred
|
3.3%
7/215 • Number of events 7 • 30 days after last dose approximately up to 24 months
|
5.6%
12/216 • Number of events 13 • 30 days after last dose approximately up to 24 months
|
4.4%
19/431 • Number of events 20 • 30 days after last dose approximately up to 24 months
|
|
Investigations
Weight decreased
|
5.1%
11/215 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
3.7%
8/216 • Number of events 10 • 30 days after last dose approximately up to 24 months
|
4.4%
19/431 • Number of events 21 • 30 days after last dose approximately up to 24 months
|
|
Investigations
White blood cell count decreased
|
5.6%
12/215 • Number of events 18 • 30 days after last dose approximately up to 24 months
|
4.6%
10/216 • Number of events 11 • 30 days after last dose approximately up to 24 months
|
5.1%
22/431 • Number of events 29 • 30 days after last dose approximately up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER