Trial Outcomes & Findings for A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL (NCT NCT02518113)
NCT ID: NCT02518113
Last Updated: 2019-09-11
Results Overview
A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria: CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of the patient from the study during Cycle 1).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Cycle 1 (Up To 28 Days)
Results posted on
2019-09-11
Participant Flow
Study completers are those participants that completed Part A cycle 1 or experienced a DLT. There were no participants enrolled to Part B and Phase 2 of the study.
Participant milestones
| Measure |
50 mg LY3039478 + Dexamethasone
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
15
|
3
|
|
Overall Study
COMPLETED
|
3
|
7
|
11
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
0
|
Reasons for withdrawal
| Measure |
50 mg LY3039478 + Dexamethasone
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
2
|
3
|
0
|
Baseline Characteristics
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
Baseline characteristics by cohort
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=3 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.83 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
36.42 years
STANDARD_DEVIATION 13.40 • n=7 Participants
|
45.87 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
26.67 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
39.94 years
STANDARD_DEVIATION 14.21 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up To 28 Days)Population: All participants who received at least one dose of study drug in Part A.
A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria: CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of the patient from the study during Cycle 1).
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=3 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Days)Population: All participants who received at least one dose of study drug in Part A.
A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria:CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting.A dose-limiting equivalent toxicity (DLET) was defined as an AE occurring between Day 1 and Day 28 of any cycle (other than Cycle 1) for a patient enrolled in the Phase 1 portion or in any cycle (including Cycle 1) for a patient enrolled in the Phase 2 portion that would have met the criteria for DLT if it had occurred during Cycle 1 for a patient enrolled in the Phase 1 portion.
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=36 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Recommended Dose of LY3039478 in Combination With Dexamethasone
|
75 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Objective Disease Progression (Up To 2 Months)Population: All participants who received at least one dose of study drug in Part A.
ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of patients achieving a CR or a CRi divided by the total number of patients randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=3 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 1-2, 3-4,6-8,24-30 hoursPopulation: All participants who received at least one dose of study drug in Part A and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC\[0-∞\]) of LY3039478 in Combination with Dexamethasone in Day 1
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=5 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=2 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1
|
3480 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
5000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 45
|
5870 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
6330 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
For n=2, range 3180-12600 was reported.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose, 1-2, 3-4,6-8,24-30 hoursPopulation: All participants who received at least one dose of study drug in Part A and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC\[0- 48\]) of LY3039478 in Combination with Dexamethasone in Day 8
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=5 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=8 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=2 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8
|
3050 ng*h/mL
Geometric Coefficient of Variation 18
|
4070 ng*h/mL
Geometric Coefficient of Variation 92
|
4640 ng*h/mL
Geometric Coefficient of Variation 55
|
8240 ng*h/mL
Geometric Coefficient of Variation NA
For n=2, range 4410-16100 was reported.
|
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression (Up To 12 Months)Population: All participants who received at least one dose of study drug in Part A.
ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of participants achieving a CR or a CRi divided by the total number of participants randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.
Outcome measures
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 Participants
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 Participants
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 Participants
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
125 mg LY3039478 + Dexamethasone
n=3 Participants
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
|---|---|---|---|---|
|
Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression (Up To 12 Months)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression (Up To 12 Months)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of CR to Relapse or Death from any Cause (Approximately 1 Year)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression or Death from Any Cause (Approximately 1 Year)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the Date of Death from Any Cause (Approximately 1.5 Years)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, End of Study (Approximately 1.5 Years)Population: Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Outcome measures
Outcome data not reported
Adverse Events
50 mg LY3039478 + Dexamethasone
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
75 mg LY3039478 + Dexamethasone
Serious events: 11 serious events
Other events: 12 other events
Deaths: 8 deaths
100 mg LY3039478 + Dexamethasone
Serious events: 9 serious events
Other events: 15 other events
Deaths: 12 deaths
125 mg LY3039478 + Dexamethasone
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 participants at risk
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 participants at risk
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 participants at risk
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
|
125 mg LY3039478 + Dexamethasone
n=3 participants at risk
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
16.7%
2/12 • Number of events 3 • Up To 16 Months
|
13.3%
2/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 5 • Up To 16 Months
|
|
Gastrointestinal disorders
Gastric ulcer
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 3 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
General disorders
Pain
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
H1n1 influenza
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 2 • Up To 16 Months
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Injury, poisoning and procedural complications
Overdose
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up To 16 Months
|
25.0%
3/12 • Number of events 3 • Up To 16 Months
|
13.3%
2/15 • Number of events 3 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 3 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
25.0%
3/12 • Number of events 3 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
Other adverse events
| Measure |
50 mg LY3039478 + Dexamethasone
n=6 participants at risk
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
75 mg LY3039478 + Dexamethasone
n=12 participants at risk
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
|
100 mg LY3039478 + Dexamethasone
n=15 participants at risk
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
|
125 mg LY3039478 + Dexamethasone
n=3 participants at risk
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • Number of events 4 • Up To 16 Months
|
16.7%
2/12 • Number of events 3 • Up To 16 Months
|
20.0%
3/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 4 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Cardiac disorders
Supraventricular tachycardia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Ear and labyrinth disorders
Hypoacusis
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Exophthalmos
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Eye disorders
Vitritis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
26.7%
4/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 3 • Up To 16 Months
|
58.3%
7/12 • Number of events 20 • Up To 16 Months
|
53.3%
8/15 • Number of events 19 • Up To 16 Months
|
66.7%
2/3 • Number of events 6 • Up To 16 Months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Gastrointestinal disorders
Lip dry
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
41.7%
5/12 • Number of events 8 • Up To 16 Months
|
33.3%
5/15 • Number of events 6 • Up To 16 Months
|
100.0%
3/3 • Number of events 8 • Up To 16 Months
|
|
Gastrointestinal disorders
Oesophagitis
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
25.0%
3/12 • Number of events 4 • Up To 16 Months
|
53.3%
8/15 • Number of events 8 • Up To 16 Months
|
100.0%
3/3 • Number of events 9 • Up To 16 Months
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up To 16 Months
|
25.0%
3/12 • Number of events 5 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Chills
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Complication associated with device
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Face oedema
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up To 16 Months
|
25.0%
3/12 • Number of events 3 • Up To 16 Months
|
40.0%
6/15 • Number of events 10 • Up To 16 Months
|
66.7%
2/3 • Number of events 8 • Up To 16 Months
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
8.3%
1/12 • Number of events 3 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
25.0%
3/12 • Number of events 4 • Up To 16 Months
|
26.7%
4/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 3 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Corona virus infection
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Cytomegalovirus infection
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Epstein-barr virus infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Infective glossitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Injury, poisoning and procedural complications
Overdose
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
16.7%
2/12 • Number of events 4 • Up To 16 Months
|
20.0%
3/15 • Number of events 5 • Up To 16 Months
|
33.3%
1/3 • Number of events 2 • Up To 16 Months
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
16.7%
2/12 • Number of events 6 • Up To 16 Months
|
26.7%
4/15 • Number of events 8 • Up To 16 Months
|
33.3%
1/3 • Number of events 3 • Up To 16 Months
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 4 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 5 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Chest x-ray abnormal
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 2 • Up To 16 Months
|
33.3%
1/3 • Number of events 5 • Up To 16 Months
|
|
Investigations
Immunoglobulins decreased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
16.7%
2/12 • Number of events 8 • Up To 16 Months
|
26.7%
4/15 • Number of events 8 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 9 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Investigations
Weight increased
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 3 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
16.7%
2/12 • Number of events 3 • Up To 16 Months
|
33.3%
5/15 • Number of events 5 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
2/6 • Number of events 4 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 4 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
33.3%
5/15 • Number of events 7 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
25.0%
3/12 • Number of events 5 • Up To 16 Months
|
53.3%
8/15 • Number of events 14 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
16.7%
2/12 • Number of events 8 • Up To 16 Months
|
13.3%
2/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
26.7%
4/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 5 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
26.7%
4/15 • Number of events 5 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
40.0%
6/15 • Number of events 6 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
20.0%
3/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
3/6 • Number of events 3 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
26.7%
4/15 • Number of events 4 • Up To 16 Months
|
33.3%
1/3 • Number of events 2 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
33.3%
1/3 • Number of events 1 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
13.3%
2/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 2 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
16.7%
2/12 • Number of events 2 • Up To 16 Months
|
6.7%
1/15 • Number of events 3 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
6.7%
1/15 • Number of events 1 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up To 16 Months
|
0.00%
0/12 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Number of events 2 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
13.3%
2/15 • Number of events 2 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/6 • Up To 16 Months
|
8.3%
1/12 • Number of events 1 • Up To 16 Months
|
0.00%
0/15 • Up To 16 Months
|
0.00%
0/3 • Up To 16 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60