Trial Outcomes & Findings for Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer (NCT NCT01012817)
NCT ID: NCT01012817
Last Updated: 2025-09-15
Results Overview
The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine \>= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is \< the upper limit of normal, or other \>= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. \>= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
4
|
6
|
7
|
3
|
4
|
3
|
6
|
5
|
7
|
3
|
31
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
6
|
6
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 Dose Level 1
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
n=3 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
n=4 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
n=6 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
n=7 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
n=3 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
n=4 Participants
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
n=3 Participants
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
n=6 Participants
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
n=5 Participants
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
n=7 Participants
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
n=3 Participants
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
n=31 Participants
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
58.7 years
n=7 Participants
|
67.7 years
n=5 Participants
|
62.3 years
n=4 Participants
|
60.3 years
n=21 Participants
|
59.7 years
n=8 Participants
|
50.3 years
n=8 Participants
|
52 years
n=24 Participants
|
54 years
n=42 Participants
|
56.2 years
n=42 Participants
|
56.2 years
n=42 Participants
|
50.1 years
n=42 Participants
|
55 years
n=36 Participants
|
60.8 years
n=36 Participants
|
58.0 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
31 Participants
n=36 Participants
|
87 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 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
|
0 Participants
n=36 Participants
|
1 Participants
n=24 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
|
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
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
29 Participants
n=36 Participants
|
84 Participants
n=24 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
|
1 Participants
n=36 Participants
|
1 Participants
n=24 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
|
1 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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=36 Participants
|
2 Participants
n=24 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
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
83 Participants
n=24 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
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 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
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All phase 1 patients that received treatment per protocol and evaluated for adverse events.
The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine \>= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is \< the upper limit of normal, or other \>= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. \>= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
n=3 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
n=3 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
n=6 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
n=6 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
n=3 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
n=3 Participants
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
n=3 Participants
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
n=6 Participants
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
n=3 Participants
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
n=6 Participants
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
n=3 Participants
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 48 weeks (12 courses)Population: All treated patients that were evaluated for disease response
The proportion of successes will be estimated by the number of successes(CR or PR) divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987). Complete Response (CR) is defined as disappearance of all target lesions and, if non target lesions exist, the disappearance of all non-target lesions and normalization of tumor maker level. At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum.
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
n=3 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
n=3 Participants
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
n=3 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
n=6 Participants
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
n=6 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
n=3 Participants
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
n=3 Participants
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
n=3 Participants
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
n=6 Participants
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
n=3 Participants
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
n=6 Participants
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
n=3 Participants
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
n=29 Participants
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors
|
0 percent of patients with response
|
33 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
17 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
50 percent of patients with response
|
0 percent of patients with response
|
0 percent of patients with response
|
SECONDARY outcome
Timeframe: The time from registration to death due to any cause, assessed up to 5 yearsThe distribution of survival time for phase 2 patients will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 yearsThe distribution of progression free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsDuration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 yearsTime to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsThe maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Dose Level 10
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1 Dose Level 11
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1 Dose Level 12
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1 Dose Level 13
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 2
Serious events: 12 serious events
Other events: 29 other events
Deaths: 2 deaths
Phase 1 Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Dose Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Dose Level 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1 Dose Level 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1 Dose Level 6
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1 Dose Level 7
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Dose Level 8
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 Dose Level 9
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
n=6 participants at risk
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
n=5 participants at risk
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
n=7 participants at risk
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
n=3 participants at risk
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
n=31 participants at risk
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
n=3 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
n=3 participants at risk
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
n=4 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
n=6 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
n=7 participants at risk
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
n=3 participants at risk
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
n=4 participants at risk
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
n=3 participants at risk
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Fever
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
ECG QT corrected interval prolonged
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
50.0%
3/6 • Number of events 3 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 2 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
Other adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 10
n=6 participants at risk
Patients receive 150qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 11
n=5 participants at risk
Patients receive 200qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 12
n=7 participants at risk
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 13
n=3 participants at risk
Patients receive 400qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
n=31 participants at risk
Patients receive 300qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 2
n=3 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 2mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 3
n=3 participants at risk
Patients receive 10qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 4
n=4 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 5
n=6 participants at risk
Patients receive 20qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 6
n=7 participants at risk
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 4mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 7
n=3 participants at risk
Patients receive 30qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 8
n=4 participants at risk
Patients receive 50qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 1 Dose Level 9
n=3 participants at risk
Patients receive 100qd veliparib PO on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and 3mg/m\^2 topotecan hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
42.9%
3/7 • Number of events 11 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
50.0%
3/6 • Number of events 8 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
50.0%
2/4 • Number of events 2 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 15 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
40.0%
2/5 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 19 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 40 • 75 months
|
100.0%
6/6 • Number of events 36 • 75 months
|
100.0%
5/5 • Number of events 22 • 75 months
|
85.7%
6/7 • Number of events 53 • 75 months
|
100.0%
3/3 • Number of events 21 • 75 months
|
67.7%
21/31 • Number of events 45 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
100.0%
3/3 • Number of events 5 • 75 months
|
100.0%
4/4 • Number of events 11 • 75 months
|
100.0%
6/6 • Number of events 112 • 75 months
|
57.1%
4/7 • Number of events 34 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
75.0%
3/4 • Number of events 33 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/3 • 75 months
|
66.7%
4/6 • Number of events 15 • 75 months
|
40.0%
2/5 • Number of events 7 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 18 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
75.0%
3/4 • Number of events 12 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 4 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
42.9%
3/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
6.5%
2/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
3/3 • Number of events 11 • 75 months
|
50.0%
3/6 • Number of events 4 • 75 months
|
80.0%
4/5 • Number of events 6 • 75 months
|
42.9%
3/7 • Number of events 20 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
25.8%
8/31 • Number of events 17 • 75 months
|
66.7%
2/3 • Number of events 9 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
50.0%
2/4 • Number of events 3 • 75 months
|
83.3%
5/6 • Number of events 20 • 75 months
|
28.6%
2/7 • Number of events 6 • 75 months
|
66.7%
2/3 • Number of events 4 • 75 months
|
50.0%
2/4 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
14.3%
1/7 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Bloating
|
66.7%
2/3 • Number of events 2 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 8 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 10 • 75 months
|
50.0%
3/6 • Number of events 12 • 75 months
|
40.0%
2/5 • Number of events 8 • 75 months
|
42.9%
3/7 • Number of events 10 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
38.7%
12/31 • Number of events 25 • 75 months
|
66.7%
2/3 • Number of events 8 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
50.0%
2/4 • Number of events 2 • 75 months
|
50.0%
3/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 5 • 75 months
|
66.7%
2/3 • Number of events 4 • 75 months
|
100.0%
4/4 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 5 • 75 months
|
50.0%
3/6 • Number of events 12 • 75 months
|
60.0%
3/5 • Number of events 6 • 75 months
|
71.4%
5/7 • Number of events 20 • 75 months
|
100.0%
3/3 • Number of events 7 • 75 months
|
25.8%
8/31 • Number of events 18 • 75 months
|
33.3%
1/3 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
100.0%
4/4 • Number of events 5 • 75 months
|
50.0%
3/6 • Number of events 39 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Number of events 3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
60.0%
3/5 • Number of events 5 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
100.0%
3/3 • Number of events 7 • 75 months
|
6.5%
2/31 • Number of events 5 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
50.0%
2/4 • Number of events 4 • 75 months
|
50.0%
3/6 • Number of events 4 • 75 months
|
42.9%
3/7 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
33.3%
2/6 • Number of events 13 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 15 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
9.7%
3/31 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
40.0%
2/5 • Number of events 14 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 3 • 75 months
|
33.3%
2/6 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 21 • 75 months
|
83.3%
5/6 • Number of events 24 • 75 months
|
100.0%
5/5 • Number of events 10 • 75 months
|
85.7%
6/7 • Number of events 32 • 75 months
|
100.0%
3/3 • Number of events 9 • 75 months
|
61.3%
19/31 • Number of events 48 • 75 months
|
66.7%
2/3 • Number of events 10 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
75.0%
3/4 • Number of events 8 • 75 months
|
100.0%
6/6 • Number of events 71 • 75 months
|
71.4%
5/7 • Number of events 13 • 75 months
|
66.7%
2/3 • Number of events 11 • 75 months
|
100.0%
4/4 • Number of events 16 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 75 months
|
83.3%
5/6 • Number of events 18 • 75 months
|
60.0%
3/5 • Number of events 3 • 75 months
|
85.7%
6/7 • Number of events 21 • 75 months
|
100.0%
3/3 • Number of events 10 • 75 months
|
41.9%
13/31 • Number of events 25 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
100.0%
4/4 • Number of events 11 • 75 months
|
66.7%
4/6 • Number of events 29 • 75 months
|
57.1%
4/7 • Number of events 5 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
75.0%
3/4 • Number of events 11 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
40.0%
2/5 • Number of events 2 • 75 months
|
57.1%
4/7 • Number of events 13 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
6.5%
2/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
50.0%
3/6 • Number of events 12 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 3 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 9 • 75 months
|
0.00%
0/3 • 75 months
|
9.7%
3/31 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 27 • 75 months
|
100.0%
6/6 • Number of events 17 • 75 months
|
60.0%
3/5 • Number of events 6 • 75 months
|
85.7%
6/7 • Number of events 33 • 75 months
|
100.0%
3/3 • Number of events 9 • 75 months
|
51.6%
16/31 • Number of events 50 • 75 months
|
66.7%
2/3 • Number of events 9 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
50.0%
2/4 • Number of events 3 • 75 months
|
83.3%
5/6 • Number of events 50 • 75 months
|
57.1%
4/7 • Number of events 12 • 75 months
|
66.7%
2/3 • Number of events 12 • 75 months
|
50.0%
2/4 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
General disorders
Fever
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
57.1%
4/7 • Number of events 8 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
28.6%
2/7 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 4 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 8 • 75 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 9 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Malaise
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 5 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Neck edema
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 10 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 8 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
16.1%
5/31 • Number of events 10 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
33.3%
1/3 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 4 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Pleural infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
50.0%
3/6 • Number of events 12 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
40.0%
2/5 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 17 • 75 months
|
28.6%
2/7 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Activated partial throm time prolonged
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 3 • 75 months
|
40.0%
2/5 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
83.3%
5/6 • Number of events 19 • 75 months
|
42.9%
3/7 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
50.0%
2/4 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 75 months
|
50.0%
3/6 • Number of events 5 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 4 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
0.00%
0/5 • 75 months
|
28.6%
2/7 • Number of events 13 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
ECG QT corrected interval prolonged
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
INR increased
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
50.0%
3/6 • Number of events 8 • 75 months
|
14.3%
1/7 • Number of events 10 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 14 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Investigations - Other, specify
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/6 • 75 months
|
40.0%
2/5 • Number of events 2 • 75 months
|
28.6%
2/7 • Number of events 5 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
66.7%
2/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
83.3%
5/6 • Number of events 40 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 6 • 75 months
|
33.3%
2/6 • Number of events 5 • 75 months
|
60.0%
3/5 • Number of events 9 • 75 months
|
42.9%
3/7 • Number of events 16 • 75 months
|
33.3%
1/3 • Number of events 8 • 75 months
|
22.6%
7/31 • Number of events 17 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
50.0%
3/6 • Number of events 10 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
33.3%
1/3 • Number of events 9 • 75 months
|
50.0%
2/4 • Number of events 9 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 16 • 75 months
|
100.0%
6/6 • Number of events 23 • 75 months
|
60.0%
3/5 • Number of events 16 • 75 months
|
71.4%
5/7 • Number of events 32 • 75 months
|
66.7%
2/3 • Number of events 8 • 75 months
|
48.4%
15/31 • Number of events 31 • 75 months
|
66.7%
2/3 • Number of events 11 • 75 months
|
66.7%
2/3 • Number of events 3 • 75 months
|
75.0%
3/4 • Number of events 10 • 75 months
|
100.0%
6/6 • Number of events 41 • 75 months
|
85.7%
6/7 • Number of events 32 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
50.0%
2/4 • Number of events 8 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 19 • 75 months
|
100.0%
6/6 • Number of events 21 • 75 months
|
60.0%
3/5 • Number of events 13 • 75 months
|
71.4%
5/7 • Number of events 15 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
64.5%
20/31 • Number of events 44 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
50.0%
2/4 • Number of events 6 • 75 months
|
83.3%
5/6 • Number of events 87 • 75 months
|
71.4%
5/7 • Number of events 34 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
50.0%
2/4 • Number of events 9 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
|
Investigations
Weight loss
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 32 • 75 months
|
100.0%
6/6 • Number of events 29 • 75 months
|
80.0%
4/5 • Number of events 26 • 75 months
|
71.4%
5/7 • Number of events 38 • 75 months
|
100.0%
3/3 • Number of events 9 • 75 months
|
45.2%
14/31 • Number of events 37 • 75 months
|
66.7%
2/3 • Number of events 9 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
50.0%
2/4 • Number of events 7 • 75 months
|
66.7%
4/6 • Number of events 44 • 75 months
|
71.4%
5/7 • Number of events 29 • 75 months
|
33.3%
1/3 • Number of events 13 • 75 months
|
75.0%
3/4 • Number of events 23 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 5 • 75 months
|
83.3%
5/6 • Number of events 18 • 75 months
|
60.0%
3/5 • Number of events 4 • 75 months
|
71.4%
5/7 • Number of events 20 • 75 months
|
100.0%
3/3 • Number of events 7 • 75 months
|
22.6%
7/31 • Number of events 11 • 75 months
|
33.3%
1/3 • Number of events 7 • 75 months
|
66.7%
2/3 • Number of events 4 • 75 months
|
75.0%
3/4 • Number of events 7 • 75 months
|
50.0%
3/6 • Number of events 30 • 75 months
|
42.9%
3/7 • Number of events 6 • 75 months
|
66.7%
2/3 • Number of events 10 • 75 months
|
50.0%
2/4 • Number of events 3 • 75 months
|
66.7%
2/3 • Number of events 10 • 75 months
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • Number of events 2 • 75 months
|
66.7%
4/6 • Number of events 7 • 75 months
|
60.0%
3/5 • Number of events 3 • 75 months
|
28.6%
2/7 • Number of events 6 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
12.9%
4/31 • Number of events 15 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 4 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
50.0%
3/6 • Number of events 33 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 2 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 5 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Number of events 15 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
6.5%
2/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 26 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
60.0%
3/5 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
66.7%
2/3 • Number of events 5 • 75 months
|
0.00%
0/4 • 75 months
|
50.0%
3/6 • Number of events 8 • 75 months
|
28.6%
2/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 8 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
33.3%
1/3 • Number of events 1 • 75 months
|
33.3%
2/6 • Number of events 8 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 12 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 11 • 75 months
|
50.0%
3/6 • Number of events 7 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
42.9%
3/7 • Number of events 9 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Number of events 6 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 23 • 75 months
|
0.00%
0/3 • 75 months
|
9.7%
3/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 6 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 22 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/3 • 75 months
|
50.0%
3/6 • Number of events 5 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 8 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
9.7%
3/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • 75 months
|
50.0%
3/6 • Number of events 14 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
14.3%
1/7 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 11 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
9.7%
3/31 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 4 • 75 months
|
25.0%
1/4 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 5 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • Number of events 8 • 75 months
|
50.0%
3/6 • Number of events 16 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
14.3%
1/7 • Number of events 7 • 75 months
|
100.0%
3/3 • Number of events 5 • 75 months
|
22.6%
7/31 • Number of events 12 • 75 months
|
33.3%
1/3 • Number of events 9 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
83.3%
5/6 • Number of events 42 • 75 months
|
28.6%
2/7 • Number of events 3 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
25.0%
1/4 • Number of events 10 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 11 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 8 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 11 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 13 • 75 months
|
33.3%
1/3 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
33.3%
2/6 • Number of events 16 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 6 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
6.5%
2/31 • Number of events 9 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Number of events 7 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
40.0%
2/5 • Number of events 2 • 75 months
|
42.9%
3/7 • Number of events 9 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
16.1%
5/31 • Number of events 15 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
50.0%
2/4 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
6.5%
2/31 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Insomnia
|
100.0%
3/3 • Number of events 6 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
28.6%
2/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 18 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 12 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
40.0%
2/5 • Number of events 4 • 75 months
|
14.3%
1/7 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 36 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
28.6%
2/7 • Number of events 5 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 8 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
28.6%
2/7 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
66.7%
2/3 • Number of events 2 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
16.7%
1/6 • Number of events 10 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • 75 months
|
33.3%
2/6 • Number of events 7 • 75 months
|
0.00%
0/5 • 75 months
|
57.1%
4/7 • Number of events 6 • 75 months
|
0.00%
0/3 • 75 months
|
22.6%
7/31 • Number of events 17 • 75 months
|
33.3%
1/3 • Number of events 7 • 75 months
|
33.3%
1/3 • Number of events 3 • 75 months
|
0.00%
0/4 • 75 months
|
66.7%
4/6 • Number of events 48 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
66.7%
2/3 • Number of events 6 • 75 months
|
25.0%
1/4 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 5 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 7 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 3 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
42.9%
3/7 • Number of events 9 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 4 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
9.7%
3/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 4 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 4 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 17 • 75 months
|
33.3%
2/6 • Number of events 10 • 75 months
|
20.0%
1/5 • Number of events 4 • 75 months
|
28.6%
2/7 • Number of events 17 • 75 months
|
100.0%
3/3 • Number of events 7 • 75 months
|
19.4%
6/31 • Number of events 25 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
25.0%
1/4 • Number of events 1 • 75 months
|
66.7%
4/6 • Number of events 45 • 75 months
|
57.1%
4/7 • Number of events 10 • 75 months
|
33.3%
1/3 • Number of events 11 • 75 months
|
25.0%
1/4 • Number of events 10 • 75 months
|
33.3%
1/3 • Number of events 10 • 75 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 7 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 8 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 19 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
16.1%
5/31 • Number of events 11 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
3.2%
1/31 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 2 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
40.0%
2/5 • Number of events 3 • 75 months
|
42.9%
3/7 • Number of events 8 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 12 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
14.3%
1/7 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
12.9%
4/31 • Number of events 7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
6.5%
2/31 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
33.3%
1/3 • Number of events 1 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/6 • 75 months
|
14.3%
1/7 • Number of events 1 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/3 • 75 months
|
0.00%
0/6 • 75 months
|
0.00%
0/5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
16.7%
1/6 • Number of events 2 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 75 months
|
16.7%
1/6 • Number of events 1 • 75 months
|
20.0%
1/5 • Number of events 1 • 75 months
|
14.3%
1/7 • Number of events 2 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/31 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
33.3%
2/6 • Number of events 5 • 75 months
|
0.00%
0/7 • 75 months
|
0.00%
0/3 • 75 months
|
0.00%
0/4 • 75 months
|
0.00%
0/3 • 75 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60