Trial Outcomes & Findings for A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies (NCT NCT00983619)
NCT ID: NCT00983619
Last Updated: 2020-05-13
Results Overview
Optimal biologic dose (OBD) was defined as the dose lower than the maximum tolerated dose (MTD), used for dose expansion. The MTD is defined as the highest dose at which less than equal to (\<=) 1 out of 6 participants experience a dose limiting toxicities (DLT) from the time of first administration of MEDI-551 through the first 28-day cycle.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Day 1 to Day 28 of Cycle 1
Results posted on
2020-05-13
Participant Flow
A total of 137 participants were screened, out of which 1 participant never received the study treatment. A total of 136 participants received study treatment.
Participant milestones
| Measure |
Part A-MEDI-551 0.5 mg/kg
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
6
|
3
|
76
|
3
|
3
|
1
|
3
|
17
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
9
|
0
|
1
|
0
|
0
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
5
|
3
|
67
|
3
|
2
|
1
|
3
|
11
|
11
|
Reasons for withdrawal
| Measure |
Part A-MEDI-551 0.5 mg/kg
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
3
|
1
|
23
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
2
|
2
|
1
|
2
|
30
|
1
|
0
|
1
|
2
|
9
|
8
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
0
|
12
|
2
|
2
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
Baseline characteristics by cohort
| Measure |
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
TOTAL
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 19.5 • n=5 Participants
|
69.5 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
64.7 Years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
60.0 Years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
64.4 Years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
61.3 Years
STANDARD_DEVIATION 20.8 • n=8 Participants
|
70.0 Years
STANDARD_DEVIATION 7.0 • n=24 Participants
|
78.0 Years
STANDARD_DEVIATION NA • n=42 Participants
|
68.0 Years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
69.4 Years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
67.9 Years
STANDARD_DEVIATION 11.0 • n=42 Participants
|
65.7 Years
STANDARD_DEVIATION 11.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
55 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
81 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
70 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
130 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
122 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28 of Cycle 1Population: Dose limiting toxicity evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle 1).
Optimal biologic dose (OBD) was defined as the dose lower than the maximum tolerated dose (MTD), used for dose expansion. The MTD is defined as the highest dose at which less than equal to (\<=) 1 out of 6 participants experience a dose limiting toxicities (DLT) from the time of first administration of MEDI-551 through the first 28-day cycle.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=95 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Optimal Biologic Dose of MEDI-551 for Part A
|
—
|
12 mg/Kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 28 of Cycle 1Population: DLT evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle).
Highest protocol-defined dose is dose of MEDI-551 in the absence of exceeding the MTD in participants with relapsed or rituximab-refractory chronic lymphocytic leukemia (defined as those with less than a partial response (PR) or progression within 6 months after completing therapy with rituximab). The MTD is defined as the highest dose at which \<= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=7 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Highest Protocol-defined Dose for Part B
|
—
|
24 mg/Kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 28 of Cycle 1Population: DLT evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle 1).
Highest protocol-defined dose is the dose of MEDI-551 in combination with rituximab at the MTD or the highest protocol-defined dose in the absence of exceeding the MTD in participants with aggressive lymphomas. The MTD is defined as the highest dose at which \<= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=20 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Highest Protocol-defined Dose for Part C
|
—
|
12 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part A, Part B, and Part C
TESAEs
|
—
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
23 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part A, Part B, and Part C
TEAEs
|
—
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
76 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 28 of Cycle 1Population: DLT evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle 1).
A dose limiting toxicities (DLT) for arm A, B, and C was defined as MEDI-551 (or rituximab for Arm C) treatment-related AE of any toxicity grade that led to an inability to receive a full cycle of MEDI-551 (or rituximab for Arm C) or any Grade 3 or higher toxicity (except Grade 3 fever, transient Grade 3 rigors or chills, Grade 3 tumor lysis syndrome, any Grade 3 or 4 electrolyte alteration, any Grade 3 liver function test elevation,\>= Grade 3 or 4 lymphopenia or leukopenia, \<= Grade 4 neutropenia, \<= Grade 4 thrombocytopenia, \<= Grade 4 anemia, and Grade 3 infusion-related reaction and infusion reaction), during DLT evaluable period.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities of MEDI-551 in Part A, Part B, and Part C
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Gamma-glutamyl transferase increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood fibrinogen increased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Neutrophil count abnormal
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Neutrophil count decreased
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Platelet count decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Reticulocytosis
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood alkaline phosphatase increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood potassium decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypercalcemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Anemia
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood fibrinogen decreased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Febrile neutropenia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hematocrit decreased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hemoglobin increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Leukopenia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Lymphocyte count decreased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood uric acid increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Lymphopenia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Myelocytosis
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Neutropenia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Red blood cell count decreased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Thrombocytopenia
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
White blood cell count decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypergammaglobulinemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Activated PTT prolonged
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Leukocytosis
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Alanine aminotransferase increased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Aspartate aminotransferase increased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood chloride decreased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood creatinine increased
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood glucose decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood glucose increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood lactate dehydrogenase increased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood urea increased
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hyperbilirubinemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hyperglycemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hyperkalemia
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hyperuricemia
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypocalcemia
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypoglycemia
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypokalemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypomagnesemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hyponatremia
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Protein total decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Blood albumin decreased
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypernatremia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hypoalbuminemia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Haematuria
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Dysuria
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Pollakiuria
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hemoglobinuria
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Hydronephrosis
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C
Urinary incontinence
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure, pulse rate, respiratory rate, and pulse oximetry).
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Bradycardia
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Dyspnea
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Chills
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Hypertension
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Hypotension
|
—
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Orthostatic hypotension
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Palpitations
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Pyrexia
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
16 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Systolic hypertension
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C
Tachycardia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, and QT intervals from the primary lead of the digital 12-lead ECG.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Supraventricular tachycardia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Sinus bradycardia
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Atrial fibrillation
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Mitral valve incompetence
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Supraventricular extrasystoles
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Tricuspid valve incompetence
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
ECG QT prolonged
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Atrial flutter
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C
Atrial tachycardia
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Complete response (CR) is defined as disappearance of all evidence of disease according to International Working Group criteria (IWG). For nodal masses; fluorodeoxyglucose (FDG)-avid or polyethylene terephthalate (PET) positive prior to therapy; mass of any size permitted if PET negative .Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT). For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry (IHC) was negative.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=16 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=13 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Response for Part B, Part C, and Part D
|
—
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
—
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
18.8 Percentage of Participants
Interval 4.0 to 45.6
|
0 Percentage of Participants
Interval 0.0 to 24.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The PR is defined as regression of measurable disease and no new sites according to IWG criteria. Nodal masses: \>= 50% decrease in sum of the product diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. Spleen and liver: \>= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone marrow: irrelevant if positive prior to therapy.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=16 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=13 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Partial Response for Part B, Part C, and Part D
|
—
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
33.3 Percentage of Participants
|
25.0 Percentage of Participants
|
23.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of CR is calculated for participants with CR.
Duration of CR is from the first documentation of a CR to the time of progressive disease/relapse according to IWG criteria. The CR is disappearance of all evidence of disease according to IWG criteria. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. Kaplan-Meier method was used to evaluate duration of CR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=1 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Complete Response for Part B, Part C, and Part D
|
—
|
NA Months
Interval 5.6 to 5.6
Median was not estimable because insufficient number of participants had the events.
|
—
|
—
|
NA Months
Interval 0.3 to 0.3
Median was not estimable because insufficient number of participants had the events.
|
NA Months
Interval 20.0 to 38.4
Median was not estimable because insufficient number of participants had the events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Objective response rate (ORR) is proportion of participants with CR or partial response (PR) as per IWG criteria. CR is disappearance of all evidence of disease. Nodal masses; FDG-avid/PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. Spleen; not palpable, nodules disappeared. Bone marrow; infiltrate cleared on repeat biopsy; if unknown by morphology, IHC was negative. PR is regression of measurable disease and no new sites. Nodal masses: \>= 50% decrease in sum of the product diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. Spleen and liver: \>= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone marrow: irrelevant if positive prior to therapy.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=16 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=13 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate for Part B, Part C, and Part D
|
—
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
43.8 Percentage of participants
Interval 19.8 to 70.1
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. The DOR were calculated for participants with objective response.
Duration of objective response (DOR) is the first documentation of objective response to the first documented progressive disease (PD) or relapse according to IWG criteria. PD is defined as any new lesion or increase by \>=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) \> 1.5 cm in any axis, \>= 50% increase in SPD of more than one node, or \>= 50% increase in longest diameter of a previously identified node \> 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: \> 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate DOR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=2 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=2 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=7 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response for Part B, Part C, and Part D
|
—
|
NA Months
Interval 38.9 to 47.2
Median was not estimable because insufficient number of participants had the events.
|
27.5 Months
Interval 27.5 to 27.5
|
—
|
3.7 Months
Interval 2.4 to 3.7
|
NA Months
Interval 1.0 to 44.7
Median was not estimable because insufficient number of participants had the events.
|
3.7 Months
Interval 1.9 to 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Disease control includes CR, PR, or stable disease (SD) for at least 8 weeks according to IWG criteria. The CR is disappearance of all evidence of disease. Nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. Spleen; not palpable, nodules disappeared. Bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. PR is regression of measurable disease and no new sites. Nodal masses: \>= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Spleen and liver: \>= 50% decrease in SPD of nodules; no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy. SD is failure to attain CR/PR or PD.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=11 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control Rate for Part B, Part C, and Part D
|
—
|
100 Percentage of participants
Interval 29.2 to 100.0
|
100 Percentage of participants
Interval 29.2 to 100.0
|
—
|
100 Percentage of participants
Interval 29.2 to 100.0
|
68.8 Percentage of participants
Interval 41.3 to 89.0
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of disease control is calculated for the participants with objective response or stable disease response.
Duration of disease control is defined as the time period from start of MEDI-551 administration to the event of PD/relapse. PD is defined as any new lesion or increase by \>=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) \> 1.5 cm in any axis, \>= 50% increase in SPD of more than one node, or \>= 50% increase in longest diameter of a previously identified node \> 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: \> 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate duration of disease control.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=11 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Disease Control for Part B, Part C, and Part D
|
—
|
NA Months
Interval 9.7 to 50.9
Median was not estimable because insufficient number of participants had the events.
|
29.8 Months
Interval 22.6 to 39.5
|
—
|
5.5 Months
Interval 4.2 to 5.5
|
14.6 Months
Interval 1.7 to 46.5
|
3.8 Months
Interval 3.5 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. TTR were calculated for the participants with objective response.
Time to response (TTR) is measured from the start of MEDI-551 administration to the first documentation of response (CR or PR) and assessed in participants who have achieved objective response. Kaplan-Meier method was used to evaluate TTR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=2 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=2 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=7 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response for Part B, Part C, and Part D
|
—
|
6.5 Months
Interval 3.7 to 9.2
|
12.0 Months
Interval 12.0 to 12.0
|
—
|
1.8 Months
Interval 1.7 to 1.8
|
2.0 Months
Interval 1.7 to 17.3
|
1.8 Months
Interval 1.6 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Progression-free survival (PFS) is measured from the start of MEDI-551 treatment until the first documentation of disease progression, relapse or death, whichever occurs first. The PFS was censored on the date of last disease assessment for participants who have no documented PD/relapse or death prior to data cutoff, dropout, or the initiation of alternative anticancer therapy. Kaplan-Meier method was used to evaluate PFS.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=16 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=13 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival for Part B, Part C, and Part D
|
—
|
NA Months
Interval 9.7 to 50.9
Median was not estimable because insufficient number of participants had the events.
|
29.8 Months
Interval 22.6 to 39.5
|
—
|
5.5 Months
Interval 4.2 to 5.5
|
3.5 Months
Interval 0.7 to 46.5
|
2.0 Months
Interval 0.7 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Overall survival (OS) is measured from the start of MEDI-551 treatment until death. For participants who are alive at the end of study or lost to follow-up, OS will be censored on the last date when participants were known to be alive. Kaplan-Meier method was used to evaluate OS.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=16 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=13 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival for Part B, Part C, and Part D
|
—
|
NA Months
Interval 19.4 to 53.8
Median was not estimable because insufficient number of participants had the events.
|
NA Months
Interval 37.6 to 41.9
Median was not estimable because insufficient number of participants had the events.
|
—
|
25.0 Months
Interval 18.3 to 45.4
|
33.4 Months
Interval 0.9 to 51.3
|
17.9 Months
Interval 1.2 to 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=14 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part D
TEAEs
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part D
TESAEs
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=14 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Platelet count decreased
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Polycythemia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Thrombocytopenia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
White blood cell count decreased
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Blood ALP increased
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Blood bilirubin increased
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Blood LDH increased
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Blood potassium decreased
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Hypercalcemia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Hyperglycemia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Hyperuricemia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Hypocalcemia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Hypokalemia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Pollakiuria
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Urinary incontinence
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Anemia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Febrile neutropenia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Lymphocyte count decreased
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Neutropenia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D
Neutrophil count decreased
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure, pulse rate, respiratory rate, and pulse oximetry).
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=14 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Chills
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Dyspnea
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Hypertension
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Hypotension
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Palpitations
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Pyrexia
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D
Tachycardia
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 90-Day Post Last Dose (Approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, and QT intervals from the primary lead of the digital 12-lead ECG.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=14 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part D
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The CR is defined as disappearance of all evidence of disease according to IWG criteria. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative .Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Response for Part A
|
—
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
0 Percentage of Participants
Interval 0.0 to 60.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
12.5 Percentage of Participants
Interval 5.9 to 22.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The PR is defined as regression of measurable disease and no new sites according to IWG criteria. Nodal masses: \>= 50% decrease in sum of the product diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. Spleen and liver: \>= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone marrow: irrelevant if positive prior to therapy.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Partial Response for Part A
|
—
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
15.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of CR is calculated for participants with CR.
Duration of CR is from the first documentation of a CR to the time of progressive disease/relapse according to IWG criteria. The CR is disappearance of all evidence of disease. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. Kaplan-Meier method was used to evaluate duration of CR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=1 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=9 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Complete Response for Part A
|
—
|
7.1 Months
Interval 7.1 to 7.1
|
—
|
—
|
14.9 Months
Interval 14.9 to 14.9
|
—
|
14.3 Months
Interval 1.9 to 31.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The ORR is defined as proportion of participants with CR or PR according to IWG criteria. CR is disappearance of all evidence of disease. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if unknown by morphology, IHC was negative. PR is regression of measurable disease and no new sites. For nodal masses: \>= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. For spleen and liver: \>= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate for Part A
|
—
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
27.8 Percentage of participants
Interval 17.9 to 39.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. The DOR were calculated for participants with objective response.
The DOR is the first documentation of objective response to the first documented PD or relapse according to IWG criteria. PD is defined as any new lesion or increase by \>=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) \> 1.5 cm in any axis, \>= 50% increase in SPD of more than one node, or \>= 50% increase in longest diameter of a previously identified node \> 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: \> 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate DOR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=2 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=20 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response for Part A
|
—
|
8.8 Months
Interval 7.4 to 8.8
|
—
|
—
|
15.0 Months
Interval 15.0 to 15.0
|
3.0 Months
Interval 3.0 to 3.0
|
19.8 Months
Interval 0.0 to 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
Disease control includes CR, PR, or SD for at least 8 weeks according to IWG criteria. The CR is disappearance of all evidence of disease. For nodal masses; FDG -avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. PR is regression of measurable disease and no new sites. For nodal masses: \>= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. For spleen and liver: \>= 50% decrease in SPD of nodules; no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy. SD is failure to attain CR/PR or PD.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control Rate for Part A
|
—
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
73.6 Percentage of participants
Interval 61.9 to 83.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of disease control is calculated for the participants with objective response or stable disease response.
Duration of disease control is defined as the time period from start of MEDI-551 administration to the event of PD/relapse according to IWG criteria. PD is defined as any new lesion or increase by \>=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) \> 1.5 cm in any axis, \>= 50% increase in SPD of more than one node, or \>= 50% increase in longest diameter of a previously identified node \> 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: \> 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate duration of disease control.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=2 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=2 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=2 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=2 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=53 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Disease Control for Part A
|
—
|
12.6 Months
Interval 1.4 to 12.6
|
NA Months
Interval 9.4 to 21.0
Median was not estimable because insufficient number of participants had the events.
|
NA Months
Interval 3.5 to 7.4
Median was not estimable because insufficient number of participants had the events.
|
10.9 Months
Interval 3.9 to 94.9
|
6.6 Months
Interval 2.8 to 6.6
|
18.0 Months
Interval 0.9 to 49.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. TTR were calculated for the participants with objective response.
The TTR is measured from the start of MEDI-551 administration to the first documentation of response (CR or PR) and assessed in participants who have achieved objective response. Kaplan-Meier method was used to evaluate TTR.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=2 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=1 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=20 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response for Part A
|
—
|
3.7 Months
Interval 3.5 to 3.9
|
—
|
—
|
1.9 Months
Interval 1.9 to 1.9
|
3.6 Months
Interval 3.6 to 3.6
|
3.2 Months
Interval 0.3 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The PFS is measured from the start of MEDI-551 treatment until the first documentation of disease progression, relapse or death, whichever occurs first. Kaplan-Meier method was used to evaluate PFS. The PFS was censored on the date of last disease assessment for participants who have no documented PD/relapse or death prior to data cutoff, dropout, or the initiation of alternative anticancer therapy.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival for Part A
|
—
|
12.6 Months
Interval 1.4 to 12.6
|
5.9 Months
Interval 0.6 to 21.0
|
3.5 Months
Interval 1.6 to 9.9
|
4.9 Months
Interval 1.1 to 94.9
|
6.6 Months
Interval 2.1 to 6.6
|
11.3 Months
Interval 0.0 to 49.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)Population: Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.
The OS is measured from the start of MEDI-551 treatment until death. For participants who are alive at the end of study or lost to follow-up, OS will be censored on the last date when participants were known to be alive. Kaplan-Meier method was used to evaluate OS.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=5 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=72 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival for Part A
|
—
|
NA Months
Interval 1.4 to 21.5
Median was not estimable because insufficient number of participants had the events.
|
44.6 Months
Interval 0.8 to 91.5
|
9.9 Months
Interval 2.8 to 9.9
|
NA Months
Interval 1.7 to 94.9
Median was not estimable because insufficient number of participants had the events.
|
8.1 Months
Interval 2.8 to 12.5
|
45.3 Months
Interval 0.7 to 83.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For Part A: C1D1 of each cycles; For Part B: C1D1 of each cycle + C1D8, C1D15, and C1D22; For Part C: C1D2, C1D8, then Day 1 of each cycle until Cycle 10;For Part D: C1D1, C1D8, then Day 1 of each cycle until Cycle 10Population: Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551. The "Number of Participants Analyzed" denotes the number of participants evaluated for specific day.
Trough serum concentration (Ctrough) is defined as lowest concentration reached by a drug before the next dose is administered. The Ctrough concentration of MEDI-551 by treatment cycle is reported.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
Cycle 1 (C1) Day 1 (D1)
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
0.333 μg/mL
Standard Deviation 0.665
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
2.97 μg/mL
Standard Deviation 24.1
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C2D1
|
114 μg/mL
Standard Deviation 40.1
|
15.6 μg/mL
Standard Deviation 0.823
|
25.9 μg/mL
Standard Deviation 10.9
|
12.9 μg/mL
Standard Deviation 4.55
|
59.4 μg/mL
Standard Deviation 11.0
|
89.8 μg/mL
Standard Deviation 64.9
|
166 μg/mL
Standard Deviation 54.0
|
124 μg/mL
Standard Deviation 64.8
|
122 μg/mL
Standard Deviation 37.2
|
326 μg/mL
Standard Deviation 68.0
|
—
|
52.4 μg/mL
Standard Deviation 17.7
|
106 μg/mL
Standard Deviation 28.8
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C3D1
|
93.9 μg/mL
Standard Deviation 35.6
|
19.3 μg/mL
Standard Deviation 3.33
|
26.9 μg/mL
Standard Deviation 12.2
|
6.78 μg/mL
Standard Deviation 2.01
|
43.0 μg/mL
Standard Deviation 8.40
|
97.0 μg/mL
Standard Deviation 94.5
|
149 μg/mL
Standard Deviation 46.2
|
113 μg/mL
Standard Deviation 70.3
|
57.6 μg/mL
Standard Deviation 43.1
|
187 μg/mL
Standard Deviation 80.6
|
—
|
44.7 μg/mL
Standard Deviation 14.2
|
92.1 μg/mL
Standard Deviation 30.7
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C6D1
|
150 μg/mL
Standard Deviation 116
|
29.1 μg/mL
Standard Deviation 6.17
|
29.1 μg/mL
Standard Deviation 17.3
|
11.7 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
32.0 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
33.7 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
138 μg/mL
Standard Deviation 27.2
|
123 μg/mL
Standard Deviation 67.9
|
37.3 μg/mL
Standard Deviation 33.5
|
106 μg/mL
Standard Deviation 54.6
|
—
|
45.9 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
100 μg/mL
Standard Deviation 22.9
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C7D1
|
248 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
31.4 μg/mL
Standard Deviation 7.08
|
25.1 μg/mL
Standard Deviation 27.8
|
9.93 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
38.2 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
27.9 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
144 μg/mL
Standard Deviation 42.4
|
109 μg/mL
Standard Deviation 64.2
|
28.1 μg/mL
Standard Deviation 21.2
|
95.1 μg/mL
Standard Deviation 54.4
|
—
|
45.3 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
108 μg/mL
Standard Deviation 20.2
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C9D1
|
192 μg/mL
Standard Deviation 25.9
|
21.6 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
31.6 μg/mL
Standard Deviation 1.23
|
10.7 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
33.6 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
124 μg/mL
Standard Deviation 23.2
|
121 μg/mL
Standard Deviation 77.5
|
27.3 μg/mL
Standard Deviation 27.1
|
94.8 μg/mL
Standard Deviation 69.4
|
—
|
—
|
95.0 μg/mL
Standard Deviation 7.59
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C10D1
|
215 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
17.6 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
25.1 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
10.6 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
32.9 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
98.3 μg/mL
Standard Deviation 5.05
|
139 μg/mL
Standard Deviation 80.4
|
33.4 μg/mL
Standard Deviation 34.8
|
84.2 μg/mL
Standard Deviation 57.4
|
—
|
—
|
113 μg/mL
Standard Deviation 27.6
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C4D1
|
102 μg/mL
Standard Deviation 61.5
|
20.9 μg/mL
Standard Deviation 6.69
|
36.5 μg/mL
Standard Deviation 0.550
|
5.59 μg/mL
Standard Deviation 0.146
|
37.9 μg/mL
Standard Deviation 13.8
|
33.4 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
146 μg/mL
Standard Deviation 55.5
|
113 μg/mL
Standard Deviation 57.1
|
36.0 μg/mL
Standard Deviation 31.6
|
134 μg/mL
Standard Deviation 67.7
|
—
|
48.2 μg/mL
Standard Deviation 20.8
|
113 μg/mL
Standard Deviation 70.0
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C1D2
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
NA μg/mL
Standard Deviation NA
The sample was below limit of quantification.
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C1D8
|
109 μg/mL
Standard Deviation 58.5
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
46.5 μg/mL
Standard Deviation 20.9
|
102 μg/mL
Standard Deviation 25.0
|
125 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
58.0 μg/mL
Standard Deviation 14.3
|
115 μg/mL
Standard Deviation 38.0
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C1D15
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
81.8 μg/mL
Standard Deviation 38.3
|
197 μg/mL
Standard Deviation 51.2
|
329 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C1D22
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
116 μg/mL
Standard Deviation 47.4
|
281 μg/mL
Standard Deviation 29.5
|
—
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C5D1
|
147 μg/mL
Standard Deviation 105
|
26.6 μg/mL
Standard Deviation 7.17
|
46.8 μg/mL
Standard Deviation 8.03
|
—
|
56.9 μg/mL
Standard Deviation 19.6
|
31.8 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
136 μg/mL
Standard Deviation 19.3
|
117 μg/mL
Standard Deviation 60.9
|
35.7 μg/mL
Standard Deviation 32.0
|
121 μg/mL
Standard Deviation 78.1
|
—
|
51.6 μg/mL
Standard Deviation 2.64
|
102 μg/mL
Standard Deviation 26.3
|
|
Trough Serum Concentration of MEDI-551 by Treatment Cycle
C8D1
|
177 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
27.1 μg/mL
Standard Deviation 14.9
|
28.0 μg/mL
Standard Deviation 1.86
|
8.80 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
33.3 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
109 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
114 μg/mL
Standard Deviation 63.8
|
30.8 μg/mL
Standard Deviation 30.4
|
86.8 μg/mL
Standard Deviation 54.4
|
—
|
—
|
147 μg/mL
Standard Deviation 82.2
|
SECONDARY outcome
Timeframe: For Part A: C1D1 of each cycles; For Part B: C1D1 of each cycle + C1D8, C1D15, and C1D22; For Part C: C1D2, C1D8, then Day 1 of each cycle until Cycle 10;For Part D: C1D1, C1D8, then Day 1 of each cycle until Cycle 10Population: Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551. The "Number of Participants Analyzed" denotes the number of participants evaluated for specific day.
Peak serum concentration is concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
Cycle 1 (C1) Day 1 (D1)
|
260 μg/mL
Standard Deviation 87.3
|
12.3 μg/mL
Standard Deviation 1.20
|
22.8 μg/mL
Standard Deviation 1.24
|
46.0 μg/mL
Standard Deviation 22.2
|
100 μg/mL
Standard Deviation 11.0
|
166 μg/mL
Standard Deviation 59.5
|
280 μg/mL
Standard Deviation 99.1
|
240 μg/mL
Standard Deviation 90.0
|
122 μg/mL
Standard Deviation 24.2
|
335 μg/mL
Standard Deviation 79.1
|
199 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C1D2
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
160 μg/mL
Standard Deviation 23.5
|
214 μg/mL
Standard Deviation 79.9
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C2D1
|
333 μg/mL
Standard Deviation 72.7
|
27.5 μg/mL
Standard Deviation 0.752
|
43.9 μg/mL
Standard Deviation 13.2
|
48.8 μg/mL
Standard Deviation 21.7
|
149 μg/mL
Standard Deviation 29.7
|
238 μg/mL
Standard Deviation 106
|
467 μg/mL
Standard Deviation 114
|
350 μg/mL
Standard Deviation 130
|
186 μg/mL
Standard Deviation 116
|
749 μg/mL
Standard Deviation 133
|
—
|
205 μg/mL
Standard Deviation 33.5
|
304 μg/mL
Standard Deviation 108
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C3D1
|
277 μg/mL
Standard Deviation 95.7
|
26.3 μg/mL
Standard Deviation 2.20
|
46.4 μg/mL
Standard Deviation 16.6
|
58.7 μg/mL
Standard Deviation 0.783
|
145 μg/mL
Standard Deviation 31.2
|
260 μg/mL
Standard Deviation 89.6
|
374 μg/mL
Standard Deviation 116
|
326 μg/mL
Standard Deviation 110
|
155 μg/mL
Standard Deviation 38.2
|
374 μg/mL
Standard Deviation 125
|
—
|
192 μg/mL
Standard Deviation 78.1
|
311 μg/mL
Standard Deviation 74.0
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C4D1
|
295 μg/mL
Standard Deviation 116
|
30.3 μg/mL
Standard Deviation 5.46
|
48.3 μg/mL
Standard Deviation 12.7
|
63.7 μg/mL
Standard Deviation 35.1
|
161 μg/mL
Standard Deviation 85.6
|
201 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
359 μg/mL
Standard Deviation 115
|
342 μg/mL
Standard Deviation 119
|
156 μg/mL
Standard Deviation 81.7
|
384 μg/mL
Standard Deviation 169
|
—
|
212 μg/mL
Standard Deviation 84.1
|
261 μg/mL
Standard Deviation 99.4
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C5D1
|
338 μg/mL
Standard Deviation 245
|
39.4 μg/mL
Standard Deviation 6.85
|
70.8 μg/mL
Standard Deviation 5.43
|
—
|
151 μg/mL
Standard Deviation 58.1
|
203 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
372 μg/mL
Standard Deviation 113
|
347 μg/mL
Standard Deviation 98.1
|
153 μg/mL
Standard Deviation 71.6
|
363 μg/mL
Standard Deviation 261
|
—
|
250 μg/mL
Standard Deviation 82.3
|
290 μg/mL
Standard Deviation 66.0
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C7D1
|
502 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
41.3 μg/mL
Standard Deviation 4.72
|
39.5 μg/mL
Standard Deviation 30.8
|
41.0 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
123 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
182 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
383 μg/mL
Standard Deviation 54.6
|
355 μg/mL
Standard Deviation 95.7
|
174 μg/mL
Standard Deviation 60.4
|
333 μg/mL
Standard Deviation 133
|
—
|
235 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
392 μg/mL
Standard Deviation 93.0
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C8D1
|
511 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
29.9 μg/mL
Standard Deviation 12.3
|
58.2 μg/mL
Standard Deviation 16.9
|
32.2 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
130 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
409 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
367 μg/mL
Standard Deviation 102
|
164 μg/mL
Standard Deviation 52.0
|
342 μg/mL
Standard Deviation 173
|
—
|
—
|
317 μg/mL
Standard Deviation 150
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C9D1
|
593 μg/mL
Standard Deviation 200
|
32.2 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
46.8 μg/mL
Standard Deviation 5.58
|
37.8 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
127 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
391 μg/mL
Standard Deviation 79.6
|
394 μg/mL
Standard Deviation 125
|
159 μg/mL
Standard Deviation 64.7
|
299 μg/mL
Standard Deviation 69.8
|
—
|
—
|
363 μg/mL
Standard Deviation 90.3
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C10D1
|
484 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
43.3 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
33.5 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
42.3 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
133 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
307 μg/mL
Standard Deviation 49.8
|
394 μg/mL
Standard Deviation 157
|
166 μg/mL
Standard Deviation 64.1
|
316 μg/mL
Standard Deviation 189
|
—
|
—
|
349 μg/mL
Standard Deviation 70.4
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C1D8
|
303 μg/mL
Standard Deviation 97.4
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
162 μg/mL
Standard Deviation 17.3
|
393 μg/mL
Standard Deviation 80.8
|
470 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
246 μg/mL
Standard Deviation 76.1
|
115 μg/mL
Standard Deviation 38.0
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C1D15
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
182 μg/mL
Standard Deviation 31.1
|
517 μg/mL
Standard Deviation 135
|
619 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C1D22
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
208 μg/mL
Standard Deviation 46.7
|
533 μg/mL
Standard Deviation 223
|
—
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
NA μg/mL
Standard Deviation NA
Not applicable for this arm.
|
|
Peak Serum Concentration of MEDI-551 by Treatment Cycle
C6D1
|
303 μg/mL
Standard Deviation 237
|
40.4 μg/mL
Standard Deviation 3.87
|
34.4 μg/mL
Standard Deviation 4.21
|
43.2 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
123 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
198 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
345 μg/mL
Standard Deviation 101
|
337 μg/mL
Standard Deviation 82.1
|
130 μg/mL
Standard Deviation 45.7
|
349 μg/mL
Standard Deviation 140
|
—
|
209 μg/mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
332 μg/mL
Standard Deviation 102
|
SECONDARY outcome
Timeframe: Part A:Cycle(C)1 Day(D)1 (Pre & post dose [PPD] 2,6,24,48 hrs PD); PPD once a week in 4 weeks C till C71; Part B:C1 (D1,D8,D15,D22),PPD of D1 of each C till C28; Part C & D:PPD of C1 (D2,D8), predose D15 and 22, PPD of D1 of each C till C24Population: Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.
Area under the concentration-time curve at steady state (Css, AUC) of MEDI-551 is reported.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Curve at Steady State (AUCss) of MEDI-551
|
4250 μg⋅day/mL
Standard Deviation 2000
|
212 μg⋅day/mL
Standard Deviation 28.1
|
287 μg⋅day/mL
Standard Deviation 110
|
479 μg⋅day/mL
Standard Deviation 57.7
|
1660 μg⋅day/mL
Standard Deviation 778
|
2880 μg⋅day/mL
Standard Deviation 2190
|
5720 μg⋅day/mL
Standard Deviation 1620
|
4850 μg⋅day/mL
Standard Deviation 1720
|
1730 μg⋅day/mL
Standard Deviation 1030
|
4920 μg⋅day/mL
Standard Deviation 1440
|
NA μg⋅day/mL
Standard Deviation NA
Data not reported due to limited PK data up to Cycle 1 Day 15.
|
2240 μg⋅day/mL
Standard Deviation 338
|
4260 μg⋅day/mL
Standard Deviation 1340
|
SECONDARY outcome
Timeframe: Part A:Cycle(C)1 Day(D)1 (Pre & post dose [PPD] 2,6,24,48 hrs PD); PPD once a week in 4 weeks C till C71; Part B:C1 (D1,D8,D15,D22),PPD of D1 of each C till C28; Part C & D:PPD of C1 (D2,D8), predose D15 and 22, PPD of D1 of each C till C24Population: Population pharmacokinetic model included all participants who received at least one dose of MEDI-551 and provided at least one measurable serum concentration of MEDI-551.
Apparent clearance of MEDI-551 is reported.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance of MEDI-551
|
237 mL/day
Standard Deviation 72.5
|
206 mL/day
Standard Deviation 101
|
302 mL/day
Standard Deviation 173
|
373 mL/day
Standard Deviation 70.9
|
210 mL/day
Standard Deviation 28.9
|
268 mL/day
Standard Deviation 126
|
198 mL/day
Standard Deviation 44.3
|
235 mL/day
Standard Deviation 110
|
303 mL/day
Standard Deviation 108
|
243 mL/day
Standard Deviation 81.6
|
279 mL/day
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
288 mL/day
Standard Deviation 43.0
|
235 mL/day
Standard Deviation 87.5
|
SECONDARY outcome
Timeframe: Part A:Cycle(C)1 Day(D)1 (Pre & post dose [PPD] 2,6,24,48 hrs PD); PPD once a week in 4 weeks C till C71; Part B:C1 (D1,D8,D15,D22),PPD of D1 of each C till C28; Part C & D:PPD of C1 (D2,D8), predose D15 and 22, PPD of D1 of each C till C24Population: Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Central volume of distribution (Vd1) is defined as hypothetical volume into which a drug initially distributes upon administration and peripheral volume of distribution (Vd2) is defined as the sum of all tissue spaces outside the central compartment.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution of MEDI-551
Vd1
|
4510 mL
Standard Deviation 647
|
3970 mL
Standard Deviation 851
|
3920 mL
Standard Deviation 491
|
4350 mL
Standard Deviation 948
|
4070 mL
Standard Deviation 464
|
4210 mL
Standard Deviation 510
|
4230 mL
Standard Deviation 234
|
4450 mL
Standard Deviation 889
|
3560 mL
Standard Deviation 286
|
4490 mL
Standard Deviation 947
|
5690 mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
4520 mL
Standard Deviation 126
|
4350 mL
Standard Deviation 851
|
|
Volume of Distribution of MEDI-551
Vd2
|
3200 mL
Standard Deviation 1440
|
2670 mL
Standard Deviation 351
|
2010 mL
Standard Deviation 1080
|
1980 mL
Standard Deviation 888
|
2290 mL
Standard Deviation 767
|
2620 mL
Standard Deviation 1240
|
2920 mL
Standard Deviation 1070
|
3430 mL
Standard Deviation 2250
|
3290 mL
Standard Deviation 1440
|
2640 mL
Standard Deviation 1840
|
3670 mL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
4590 mL
Standard Deviation 847
|
2640 mL
Standard Deviation 1200
|
SECONDARY outcome
Timeframe: Part A:Cycle(C)1 Day(D)1 (Pre & post dose [PPD] 2,6,24,48 hrs PD); PPD once a week in 4 weeks C till C71; Part B:C1 (D1,D8,D15,D22),PPD of D1 of each C till C28; Part C & D:PPD of C1 (D2,D8), predose D15 and 22, PPD of D1 of each C till C24Population: Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.
Terminal half-life is the time required for the plasma concentration of MEDI-551 to fall by 50% during the terminal phase.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
n=14 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=67 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=1 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of MEDI-551
|
25.6 Days
Standard Deviation 7.96
|
26.0 Days
Standard Deviation 6.88
|
17.3 Days
Standard Deviation 7.65
|
13.3 Days
Standard Deviation 6.41
|
22.1 Days
Standard Deviation 3.26
|
21.7 Days
Standard Deviation 8.65
|
27.9 Days
Standard Deviation 9.08
|
28.9 Days
Standard Deviation 15.0
|
19.9 Days
Standard Deviation 9.34
|
23.8 Days
Standard Deviation 10.9
|
25.1 Days
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
25.3 Days
Standard Deviation 4.40
|
23.6 Days
Standard Deviation 9.38
|
SECONDARY outcome
Timeframe: Part A:C1D1; Part B: C1D1; Part C: C1D1; Part D: C1D1; End of treatment (EOT); 90 Days post last dose (approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551. Participants only with positive ADA is reported.
Number of participants with positive Anti-drug antibodies (ADA) titer to MEDI-551 is reported.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=3 Participants
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=17 Participants
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=14 Participants
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI-551
C1D1
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI-551
EOT
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI-551
90 Day Post Dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Part A:C1D1 of each cycles; Part B: C1D1 of each cycle + C1D8, C1D15, and C1D22; Part C: C1D2, C1D8, then Day 1 of each cycle until Cycle 10; Part D: C1D1, C1D8, Day 1 of each cycle until Cycle 10; EOT;90 Days post last dose (approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551. It was pre-specified that B-cell analysis was not required, due to limited data availability.
B-cell Concentration in serum is reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part A:C1D1 of each cycles; EOT;90 Days post last dose (approximately 9 years)Population: Safety population included all participants who received any treatment of MEDI-551.
Immunoglobin (Ig) concentration in serum is reported.
Outcome measures
| Measure |
Part D-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
Part A-MEDI-551 0.5 mg/kg
n=3 Participants
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 Participants
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 Participants
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 Participants
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 Participants
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunoglobulin (Ig) Concentration in Serum
C6D1
|
—
|
63.50 mg/dL
Standard Deviation 13.44
|
156.00 mg/dL
Standard Deviation 48.08
|
—
|
41.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
71.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
62.86 mg/dL
Standard Deviation 65.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
90 Days Post Dose
|
—
|
49.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
84.50 mg/dL
Standard Deviation 60.10
|
—
|
93.33 mg/dL
Standard Deviation 42.06
|
—
|
45.20 mg/dL
Standard Deviation 38.72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C9D1
|
—
|
51.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
137.50 mg/dL
Standard Deviation 30.41
|
46.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
41.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
62.35 mg/dL
Standard Deviation 61.90
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C10D1
|
—
|
47.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
155.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
46.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
41.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
73.17 mg/dL
Standard Deviation 66.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
EOT
|
—
|
43.50 mg/dL
Standard Deviation 12.02
|
96.00 mg/dL
Standard Deviation 80.58
|
7.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
54.40 mg/dL
Standard Deviation 46.55
|
65.33 mg/dL
Standard Deviation 19.76
|
217.25 mg/dL
Standard Deviation 1003.38
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C1D1
|
—
|
120.00 mg/dL
Standard Deviation 46.36
|
110.00 mg/dL
Standard Deviation 76.25
|
81.00 mg/dL
Standard Deviation 66.36
|
61.67 mg/dL
Standard Deviation 54.52
|
93.33 mg/dL
Standard Deviation 46.11
|
93.01 mg/dL
Standard Deviation 88.56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C2D1
|
—
|
67.50 mg/dL
Standard Deviation 7.78
|
113.67 mg/dL
Standard Deviation 92.81
|
67.67 mg/dL
Standard Deviation 58.05
|
57.00 mg/dL
Standard Deviation 47.05
|
74.50 mg/dL
Standard Deviation 47.38
|
88.90 mg/dL
Standard Deviation 92.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C3D1
|
—
|
62.50 mg/dL
Standard Deviation 6.36
|
106.00 mg/dL
Standard Deviation 87.93
|
31.00 mg/dL
Standard Deviation 29.70
|
57.25 mg/dL
Standard Deviation 48.29
|
76.50 mg/dL
Standard Deviation 50.20
|
67.90 mg/dL
Standard Deviation 66.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C4D1
|
—
|
64.00 mg/dL
Standard Deviation 9.90
|
152.50 mg/dL
Standard Deviation 13.44
|
31.00 mg/dL
Standard Deviation 33.94
|
63.67 mg/dL
Standard Deviation 56.52
|
98.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
66.84 mg/dL
Standard Deviation 61.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C5D1
|
—
|
69.00 mg/dL
Standard Deviation 11.31
|
145.50 mg/dL
Standard Deviation 38.89
|
50.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
58.67 mg/dL
Standard Deviation 45.17
|
77.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
69.24 mg/dL
Standard Deviation 70.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C7D1
|
—
|
56.00 mg/dL
Standard Deviation 1.41
|
127.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
47.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
41.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
61.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
67.26 mg/dL
Standard Deviation 69.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunoglobulin (Ig) Concentration in Serum
C8D1
|
—
|
47.00 mg/dL
Standard Deviation 7.07
|
147.00 mg/dL
Standard Deviation 28.28
|
45.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
41.00 mg/dL
Standard Deviation NA
Standard deviation is not reported as only one participant was evaluable for the specified arm.
|
—
|
73.76 mg/dL
Standard Deviation 66.87
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A-MEDI-551 0.5 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A-MEDI-551 1 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Part A-MEDI-551 2 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Part A-MEDI-551 4 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Part A-MEDI-551 8 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Part A-MEDI-551 12 mg/kg
Serious events: 23 serious events
Other events: 75 other events
Deaths: 30 deaths
Part B-MEDI-551 6 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part B-MEDI-551 12 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B-MEDI-551 24 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part C-MEDI-551 8 mg/kg + Rituximab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Part C-MEDI-551 12 mg/kg + Rituximab
Serious events: 9 serious events
Other events: 17 other events
Deaths: 9 deaths
Part D-MEDI-551 12 mg/kg
Serious events: 5 serious events
Other events: 14 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Part A-MEDI-551 0.5 mg/kg
n=3 participants at risk
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 participants at risk
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 participants at risk
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 participants at risk
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 participants at risk
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 participants at risk
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 participants at risk
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part D-MEDI-551 12 mg/kg
n=14 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Varicella
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
Other adverse events
| Measure |
Part A-MEDI-551 0.5 mg/kg
n=3 participants at risk
Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 1 mg/kg
n=4 participants at risk
Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 2 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 4 mg/kg
n=6 participants at risk
Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 8 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part A-MEDI-551 12 mg/kg
n=76 participants at risk
Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 6 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 12 mg/kg
n=3 participants at risk
Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part B-MEDI-551 24 mg/kg
n=1 participants at risk
Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
|
Part C-MEDI-551 8 mg/kg + Rituximab
n=3 participants at risk
Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part C-MEDI-551 12 mg/kg + Rituximab
n=17 participants at risk
Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
|
Part D-MEDI-551 12 mg/kg
n=14 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
34.2%
26/76 • Number of events 31 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
3/3 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
9/76 • Number of events 10 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.5%
4/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
6.6%
5/76 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
9.2%
7/76 • Number of events 11 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.5%
11/76 • Number of events 19 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
10.5%
8/76 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
75.0%
3/4 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.5%
4/17 • Number of events 18 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Hypergammaglobulinaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.1%
13/76 • Number of events 19 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 13 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
3/6 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 19 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Bradycardia
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Exophthalmos
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
13.2%
10/76 • Number of events 12 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
35.3%
6/17 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • Number of events 10 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.7%
18/76 • Number of events 21 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
29.4%
5/17 • Number of events 15 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
21.4%
3/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.1%
13/76 • Number of events 16 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
29.4%
5/17 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
21.4%
3/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
9.2%
7/76 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.5%
4/17 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Asthenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
6.6%
5/76 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Breakthrough pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Chills
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
6.6%
5/76 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Cyst
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Early satiety
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
2/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
3/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
36.8%
28/76 • Number of events 33 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
3/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
52.9%
9/17 • Number of events 20 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
35.7%
5/14 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Gravitational oedema
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Ill-defined disorder
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Malaise
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Mass
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Medical device site bruise
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Medical device site pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Necrosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Oedema
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
10.5%
8/76 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
29.4%
5/17 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
6.6%
5/76 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
2/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.1%
13/76 • Number of events 18 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
2/6 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.5%
4/17 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
9/76 • Number of events 11 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 10 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
10.5%
8/76 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
2/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
44.7%
34/76 • Number of events 108 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
28.6%
4/14 • Number of events 12 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood immunoglobulin m decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood triglycerides increased
|
33.3%
1/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Glucose urine present
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Karnofsky scale worsened
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 11 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
21.4%
3/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Mean cell volume increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Neutrophil count abnormal
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
6.6%
5/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
28.6%
4/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Occult blood positive
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Vitamin d decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
Weight increased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
21.4%
3/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
9.2%
7/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
35.7%
5/14 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
50.0%
2/4 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.5%
11/76 • Number of events 12 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
66.7%
2/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
23.5%
4/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
9/76 • Number of events 11 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.9%
6/76 • Number of events 9 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
29.4%
5/17 • Number of events 6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
13.2%
10/76 • Number of events 12 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
100.0%
1/1 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
21.4%
3/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
19.7%
15/76 • Number of events 20 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 7 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.3%
4/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Neuropathy peripheral
|
66.7%
2/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
16.7%
1/6 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Aggression
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
10.5%
8/76 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
14.3%
2/14 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Depressed mood
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/17 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
25.0%
1/4 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
3.9%
3/76 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
33.3%
1/3 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
17.6%
3/17 • Number of events 3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
7.1%
1/14 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
10.5%
8/76 • Number of events 8 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 5 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
28.6%
4/14 • Number of events 4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/76 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
1.3%
1/76 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
5.9%
1/17 • Number of events 1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/4 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/6 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
2.6%
2/76 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/1 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/3 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
11.8%
2/17 • Number of events 2 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
0.00%
0/14 • Day 1 through 90-Day Post Last Dose (Approximately 9 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Medimmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER